Australians for Ethical Stem Cell Research

Take heart! ESCs are a dud, but ASCs continue to kick goals.

2011-11-15T17:15:00.000+10:00

Right on cue, a day after Geron gives up tinkering with embryos, another report from the US of adult stem cell therapy for humans with heart failure.

Read about it or listen to it HERE at the ABC World Today.

I don't want to dampen the excitement, but of course we have had adult stem cell treatment for humans with heart failure for a decade or so - for example, an article in the Journal of the Americal College of Cardiology HERE. Nevertheless, this latest pair of studies is particularly good.

A conference in Florida has heard that two separate trials of stem cell therapy in humans have been surprisingly successful in replacing damaged muscle and getting the heart to pump better. The Heart Foundation says it could completely revolutionise the way heart failure is treated...

The first study used stem cells from the marrow:

We saw some of the hearts pumping better and patients able to walk further, but the most impressive result of this trial really are the clinical events, or what we call MACE - which stands for major adverse cardiac event - and what we saw was that there was a significant decrease in these adverse clinical events including death, requirement for revascularization procedures and heart attacks in these patients.

The second study used a patient's own heart stem cells (multiplied up and reinjected to the damaged area of heart muscle):

In the study these cells boosted the heart function by about 15 to 20 per cent and they also were also able to reduce the area of heart muscle damage by about 25 per cent. So these are findings never seen before.

I trust the significance of these two news events is not lost on our science reporters! Truly ESCs and cloning are dying a lingering and unlamented death, while ASCs for therapy are the most exciting thing in medicine today.

Puff, puff, "POP" goes the Geron ESC bubble!

2011-11-15T12:42:00.000+10:00

What a bunch of clowns at Geron Corp - massaging the share price over the decade with each new announcement of impending ESC therapies (see the comic collation HERE) and then dropping their bogus ESC experiment for spinal injury half way through a phase 1 trial (remind yourself about that HERE).

Geron announced yesterday that they are closing their spinal-injury trial to new enrolments, and laying off most of their staff in that area now, with the rest going by mid-2012. Too bad for the existing patients with a spine full of potentially tumorigenic ESC-derivatives... Geron hopes some other company will take over their "stem cell assets".

The media release of 14th November states:

The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company’s research and clinical-stage assets.

That means their ESC-derivative experiments are not promising enough to even complete the earliest-stage trial, despite all the ludicrous hype they and their media puppies propagated last year.

No doubt some government-funded body will take up these sort of futile experiments using dumb public money (futile and dumb becaause anything an ESC-derivative can do an ethically uncontentiuos iPSC-derivative can do better - because it matches the patient; even better, in spinal injury an ASC therapy would both match the patient and avoid the danger of tumours).

But in the real world, smart private money will continue to see through the hype and hoax of embryo stem cell "therapies".

RIP Geron's ESC fizzer.

Confirmation: cloning has NOT produced a single patient-matched stem cell

2011-11-08T13:02:00.001+10:00

The question was raised, from the cloning review in this month's Quadrant, as to whether last month's Nature report means our claim is now out of date, where we said: "Cloning, for all the millions spent worldwide and all the blighted human entities created and destroyed, has failed to obtain even a single pluripotent stem cell."

The answer is still no. Human cloning has still not achieved any useable pluripotent stem cell - for two reasons. First, the experiment in Nature was not true cloning - the 'Dolly' technique, creating an identical twin embryo for patient-matched stem cells - but the creation of a triploid amalgam of the donor's and the mother's nuclear DNA. The resultant genetically-mutilated embryo contains a fatal extra set of chromosomes. Second, the experiment might have been tweaked to the stage of stem cells, but these are entirely unuseable stem cells as far as "therapeutic cloning" goes. It is a new form of abuse of the human embryo, but it does not qualify as achieving cloning's goal of pluripotent stem cells that match the donor.
For clarification, here is an article by AESCR researcher, Richard Egan, with thanks to Mercatornet where it was published last month, at this LINK.

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In an article published in Nature on 6 October 2011, Scott Noggle and his colleagues at the New York Stem Cell Foundation Laboratory report on their experiments in which they have derived stem cells from human embryos created by adding the nucleus of a somatic cell to a human egg.

The fact that the stem cells were useless made no difference to the amount of publicity this latest human cloning experiment received, but the reports did draw attention again to the supply of human eggs for the research and the ethics of paying women to undergo risky superovulation.

The process used was a form of cloning. However, in standard cloning – the technique used to produce Dolly the sheep – the nucleus is removed from an egg and replaced with the nucleus from a somatic cell. In the New York experiments it was first found that this process routinely fails with human eggs, with development of the human embryo created by cloning arresting before reaching the stage at which stem cells can be extracted.

The experimenters tried leaving the nucleus of the egg in place and merely adding the nucleus from the somatic cell. It appears that this left in place some factor in the egg that is crucial to the continued development of the human embryo.

However, as a result of leaving the nucleus of the egg in place while adding the nucleus of a somatic cell was that each cell of the resulting human embryo, including the extracted stem cells, is triploid – having 69 chromosomes rather than the normal human complement of 46 chromosomes.

This means that this experiment has not achieved the goal of obtaining patient-matched stem cells by cloning or “oocyte reprogramming” as some prefer to call it these days.

The triploid cells obviously don’t match the patient’s DNA and could not be safely used in therapies. Nor are they likely to be of any use for drug testing.

Nonetheless, with cloning research otherwise stalled around the world this experiment is likely to refuel the search for a way to make cloning for human embryonic stem cells work.

The New York experimenters do have a significant advantage over other cloning researchers. The Empire State Stem Cell Board in March 2010 approved contract policy conditions that allowed researchers to pay “women donating oocytes solely for research purposes … out-of-pocket expenses, including payments for travel, housing, medical care, child care and similar expenses incurred as a result of the donation of the oocytes for research purposes and compensated for the time, inconvenience and burden associated with the donation.”

This policy enabled the New York Stem Cell Foundation Laboratory to pay 16 women to procure (the word donate seems inappropriate when payment is being made) a total of 270 fresh eggs. This is an average of nearly 17 eggs from each woman.

New York is the only jurisdiction in the world to allow payment for egg procurement for research from women who are not undergoing egg retrieval for reproductive purposes.

Superovulation, which women undergo to produce eggs in this quantity is dangerous carrying a mortality risk of between 2.52 (UK 2003-05) and 6 (Netherlands 1984-2008) per 100,000. Professor Emerita of Sociology, Dianne Beeson, has given evidence to a US Congressional hearing on the dangers that egg extraction for cloning poses to women’s health and life. Up to 14 percent of patients undergoing superovulation experience some form of ovarian hyperstimulation syndrome, or OHSS. Common symptoms of mild OHSS include abdominal discomfort, ovarian enlargement, nausea and vomiting. Those who develop severe OHSS may experience a wide range of serious conditions including loss of future fertility, kidney or multiple organ failure, and death. The frequency of severe OHSS is estimated to be as high as 10 per cent of women who undergo the procedure.

The recent Heerey review of Australia’s cloning legislation recommended in June 2011 that there be no change to the current system in Australia where women can be reimbursed for reasonable expenses in relation to egg donation but that this does not include compensation for time or loss of income. The recommendation was particularly welcome as review committee member Professor Loane Skene had been a public advocate for Australia following New York’s approach to compensation for women for undergoing the procedure of egg retrieval. Perhaps it was just as well that this review had reported before the New York experiments were reported and the results could be hyped to justify the benefits of paying women for their eggs.

Sydney IVF which holds the only three licenses for cloning issued by the NHMRC Licensing Committee relies on obtaining eggs from women undergoing IVF. As of 28 February 2011 they had used 435 “clinically unsuitable eggs” in cloning experiments but failed to obtain development beyond the compact morula stage.

The licenses were set to expire on 16 September 2011 but on 24 August 2011 the NHMRC Licensing Committee extended the licenses until 16 September 2012. This is a disappointing decision in the light of the failure of the experiments to date and the obvious unsuitability of “clinically unsuitable eggs” as research material as already established by researchers at Newcastle in Britain and elsewhere.

The Heerey review in its majority recommendation that the law continue to allow licenses for cloning for research to be issued noted that:

However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT [somatic cell nuclear transfer – the main cloning technique] research in animals and humans.

The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT

It is difficult to see how the NHMRC Licensing Committee could justify extending the Sydney IVF cloning licenses in the light of this recommendation.

However, it should be clear by now that different rules apply to cloning. Meaningless experiments are hyped as dramatic advances and snake oil salesmen are given a welcome mat and millions of dollars of funding.

QUADRANT ARTICLE: "Cloning - the Blighted Science"

2011-11-05T12:07:00.000+10:00

If your weekend reading does not already include a rollicking obituary for the brief and unlamented era of human cloning, I have a full review in the new Quadrant magazine which is available online HERE.

The article arises from the Legislative Review earlier this year into Australia's cloning laws - that Review was an opportunity for us to rethink (re-pent) the abuses formerly legislated, even on the pragmatic grounds that newer science renders cloning redundant. As expected, however, the majority of the committee members argued for the status quo - the "yes, cloning has been a dud so far and yes, Yamanaka's method seems to have achieved what cloning could never achieve - but let's just research everything anyway " approach - and thereby the Review recommendations save face for those scientists and social progressives who invested so much energy in this battle of the culture wars back in 2006.

The subheadings of the article are: End of an Era; Humans Second Class; Fraud & Fairy Tales; Reality Check on Embryos; Death Throes; The 2011 Review: Clinging to Cloning.

Cloning is a human desecration and a scientific failure. It has always been unethical, in that it creates human embryos with their destruction in mind; it is now also clearly unnecessary. The Senate vote was carried in 2006 by the argument that cloning was the only possible way to obtain “pluripotent stem cells” that perfectly match the patient. That argument lies in shreds, in part through the failure of cloning to produce results but above all through the discovery of an alternative stem cell technique which is both effective and ethically uncontentious.

"Human cloning law: on the way out?" - Guest Blog.

2011-08-16T12:47:00.000+10:00

Guest Blog by Richard Egan, research officer with the Coalition for the Defence of Human Life in WA. Richard prepared a comprehensive submission to the cloning review for the Coalition which can be viewed at: https://legislationreview.nhmrc.gov.au/sites/default/files/submissions/cdhl-sub-cloning-human-embryos-legislation-review.pdf

Richard has recently returned from a series of conferences and meetings with bioethicists in the US. We are grateful to him for letting us post this clear summary of the key points of the recent Legislative Review.
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Human cloning: on the way out?

A recent review of the law permitting human cloning for research is less than enthusiastic about cloning and admits the law may soon be outdated.

In 2002 both Houses of the Commonwealth Parliament voted unanimously to prohibit all forms of human cloning, including cloning for research. The overwhelming consensus was that it was ethically wrong to create a human embryo for the purpose of destroying it in research, including research involving the extraction of embryonic stem cells.

A majority of both Houses did, however, support legislation which permitted the use of so-called “excess” human embryos, fertilised in vitro for reproductive purposes but never implanted, to be used for research, including the extraction of embryonic stem cells.

In 2005 a review of this legislation by the Lockhart committee coincided with the six month period between the much celebrated claim by Korean scientist Hwang Woo Suk to have successfully created several human embryonic stem cell lines from cloned human embryos and the revelation that this claim was fraudulent.

Based largely on the perceived need for Australia to catch up with the (fraudulent) Korean developments the Lockhart committee recommended changing the law to permit human cloning for research.

Despite the setback of Hwang’s fraud being exposed proponents of human cloning successfully hyped the possible results from such research to persuade a bare majority of one in the Australian Senate that legislation permitting human cloning for research was the best hope that the lame would soon walk, the blind see and the diabetic discard his or her insulin supplies.

The new law permitting cloning was assented to on 12 December 2006 and came into effect six months later in July 2007.

Heerey review

The report of the review of the new legislation by a committee chaired by former Federal Court judge the Hon Peter Heerey QC was released by the Gillard government on 7 July 2011.

The past four years has not favoured the proponents of human cloning.

The report observes:

Attempts to generate human ES cells by SCNT have been pursued for over seven years and, with the notable exception of work reported from Korea and subsequently admitted to be fraudulent, are yet to produce a claim to development of a human ES cell line, though development of embryos to the eight cell stage has been achieved.

A majority of the committee did recommend that the scheme permitting human cloning for research under license continue while commenting:

However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT [somatic cell nuclear transfer – the main cloning technique] research in animals and humans.

The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT.

Committee member the Rev Fr Kevin McGovern strongly dissented from this recommendation noting:

the approach recommended by the Lockhart Review, which stated that ‘the greater the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified.’

Reverend McGovern believes that in 2011 the latter standard has been reached for SCNT. In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT?

Some scientists have proposed some possible benefits of SCNT, but their arguments are not entirely convincing. Dr Megan Munsie argues that SCNT-ES cells might more closely resemble ES cells than iPS cells. However, the evidence from animal work is that SCNT generally produces damaged or abnormal embryos. This strongly suggests that even if SCNT-ES cells more closely resemble ES cells, these SCNT-ES cells will still be genetically abnormal and inferior to ES cells.

Professor Bob Williamson advocates SCNT to generate stem cell lines as disease models to study late-onset conditions. It is not clear, however, why SCNT-derived lines would be more useful than iPSClines.

Beyond that, there is only the possibility of what ‘might’ be learnt if research into SCNT continues. The proposed benefits of SCNT research therefore seem not entirely convincing, sometimes rather small, and largely theoretical. On the other hand, SCNT involves the most profound of ethical concerns. It is the creation of human life which will be used in research and then destroyed. When people understand this, many people within the community are troubled by SCNT.

For all this, however, this most serious of ethical concerns has been judged less significant than the mostly theoretical benefits which might come if research into SCNT is allowed to continue. With this outcome, Reverend McGovern wonders whether the ethical concerns about SCNT research are ultimately being given anything more than lip-service.

The report noted that fellow committee member Dr Faye Thompson “shares Reverend McGovern’s concerns about SCNT”. So only three of the committee’s five members fully endorsed the recommendation – including known cloning advocates Professors Loane Skene and Ian Frazer who had each played a key role in the 2006 hype for cloning.

The report notes that of the total number of 264 submissions, 188 were from the general community. Of these, 112 specifically commented that they did not support human cloning, while all 188 stated that they did not support the use of human embryos for research.

In its final recommendation the report calls for a further review of the legislation each five years commenting that:

The Review Committee thinks it highly desirable that in this rapidly changing field of science there be periodic reviews. For example, it may be that by the time of the next review it has become accepted that SCNT is no longer appropriate.

Other recommendations

The Heerey committee unanimously recommended that there be no change to the legislation which prohibits payment for eggs or sperm. This was noteworthy given the very public campaign of committee member Professor Loane Skene for such a change.

The committee also rejected a proposal to change the legislation to allow the creation by fertilisation of human embryos with genetic inheritance from more than two people. Proponents claim this could help women with mitochondrial disease have children unaffected by the disease.

The majority of the committee also recommended allowing experimental research in creating human embryos using sperm or eggs derived by manipulating body cells or embryonic stem cells [in vitro derived or IVD gametes] . This technique could ultimately be used to create a child from sperm and an egg derived from a single individual or from two persons of the same sex.

Fr McGovern again dissented observing that:

the development of knowledge about human IVD gametes will lead almost inevitably to their use in human reproduction, even if many in our society are opposed to this.

The committee rejected calls from the Coalition for the Defence of Human Life and other community organisations to repeal the provisions in the law permitting the use of eggs from aborted baby girls to make human embryos for research.

In what can only be described as a lack of moral imagination the committee could not see anything to distinguish this abhorrent practice from other forms of making human embryos for research (such as cloning) or from the donation of tissue from aborted babies for other purposes. While these practices are all unethical surely there is something particularly repulsive to human and moral sensibility in making an aborted baby girl a mother only to cannibalise her offspring for speculative research.

Fr McGovern is to be commended for his forthright dissent and astute comments throughout the report. On the fundamental question of using any human embryos as a source for stem cells, including those “excess” to IVF requirements he states:

Section 8 of the NHMRC Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research requires that embryos which must be disposed of should be disposed of respectfully.

He does not believe that the evisceration of these embryos to extract their stem cells is respectful disposal. As we would be concerned if this was done to a human being at any other stage of human development, he believes that we should be concerned about this.

Indeed.

The Coalition for the Defence of Human life will continue to work for an end to all legislation that permits destructive research of any kind on any human embryo.

Media Release: Cloning left on Futile Life-Support (Legislative Review)

2011-07-08T18:39:00.001+10:00

“The Legislative Review tabled yesterday (July 7th) is a lame attempt by the majority of this (outrageously stacked) committee to keep the blighted science of SCNT/cloning on its futile life-support” said Dr David van Gend, national director of Australians for Ethical Stem Cell Research. “Section 5.3 showcases the shriveled case for cloning, with only ardent supporters of cloning (Muncie, Williamson, Elefanty) being quoted in the section and no critics quoted at all. As expected, this one-sided chorus culminates in the stale old slogan of the ethically indifferent: "let's just research everything".

“However, even the majority position – including prominent cloning advocates Ian Frazer and Loane Skene - admits to the increasing difficulty of justifying any SCNT/cloning experiments at all, given the failure of cloning and the success of its ethical alternatives:

The Review Committee notes the lack of progress in SCNT research in animals and humans. The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT

“The dissenting opinion by Kevin McGovern, Director of the Caroline Chisholm Centre for Health Ethics (and the report states “Dr Kaye Thompson shares Reverend McGovern’s concerns about SCNT”) is a masterpiece of clear thinking and demolishes the ramshackle apologia of the dominant committee members.

In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT?

“McGovern has shown the way forward for an ethical society. Shame on Minister Mark Butler who, as our association predicted, cynically delayed tabling the cloning review until the last day before the long winter recess, about 6 weeks after the date the report was put on his desk. That means Senate critics like Barnett, Fielding and McGauran are gone, and Butler ensured the Review would not be examined until a safely libertarian Greens party held the balance of power in the Senate. Under a fair-minded Senate cloning would fall; it has always been unethical and now it is clearly unnecessary, as McGovern shows. The case for cloning is now so diminished that it could never carry a conscience vote like it did in the hysterically hyped days of 2006.

“Perhaps that means the vile project of creating human embryos solely with their exploitation and destruction in mind will linger as a stain on the statutes until the wresting of control of the Senate from the Greens. However, my hope is that Labor and the Coalition will unite against the Greens to turn off the futile life-support on this blighted science”, Dr van Gend concluded.

QUOTE FROM REVIEW:

END quote

Recommendation 3: (by majority) The provisions in the current legislation regarding SCNT should not be amended.

However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT research in animals and humans. The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT.

The foregoing represents a majority view of the Review Committee. Reverend Kevin McGovern, however, notes:

The approach recommended by the Lockhart Review, which stated that ‘the greater the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified.’ Reverend McGovern believes that in 2011 the latter standard has been reached for SCNT. In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT?

Some scientists have proposed some possible benefits of SCNT, but their arguments are not entirely convincing. Dr Megan Munsie argues that SCNT-ES cells might more closely resemble ES cells than iPS cells. However, the evidence from animal work is that SCNT generally produces damaged or abnormal embryos. This strongly suggests that even if SCNT-ES cells more closely resemble ES cells, these SCNT-ES cells will still be genetically abnormal and inferior to ES cells. Professor Bob Williamson advocates SCNT to generate stem cell lines as disease models to study late-onset conditions. It is not clear, however, why SCNT-derived lines would be more useful than iPSC- lines. Beyond that, there is only the possibility of what ‘might’ be learnt if research into SCNT continues. The proposed benefits of SCNT research therefore seem not entirely convincing, sometimes rather small, and largely theoretical. On the other hand, SCNT involves the most profound of ethical concerns. It is the creation of human life which will be used in research and then destroyed. When people understand this, many people within the community are troubled by SCNT.

For all this, however, this most serious of ethical concerns has been judged less significant than the mostly theoretical benefits which might come if research into SCNT is allowed to continue. With this outcome, Reverend McGovern wonders whether the ethical concerns about SCNT research are ultimately being given anything more than lip-service.

No fizz left in the cloning bottle: Legislative Review finally released

2011-07-08T00:09:00.001+10:00

As predicted, Minister Mark Butler delayed tabling the cloning review until today, about 6 weeks after the due date for tabling in Parliament (27th May, which was in fact the date the report was put on his desk). That means potential Senate critics like Barnett, Fielding and McGauran are gone, and a safely 'progressive' Greens party holds the balance of power in the Senate.

Getting to the substance of the report, and for this post limiting it to the central question of cloning: a reading of the relevant section (5.3) shows the lame attempt by the majority of the committee to keep this sickly science on its futile life-support. This section was largely an apologia for the residual shrivelled case for cloning, with only ardent supporters of cloning (Muncie, Williamson, Elefanty) being quoted in the section and no critics quoted at all. As expected, this one-sided chorus culminates in the stale old trope of the morally menopausal: "let's just research everything".

Nevertheless, I detect throughout this report the bracing presence of Rev Kevin McGovern, Director of the Caroline Chisholm Centre for Health Ethics. His dissenting comment appended to Recommendation 3 is a masterpiece of clear thinking and demolishes the ramshackle apologia of the dominant committee members.

Read Rec 3, below, and note the 'however' from the Committee about how there is no avoiding the lack of progress / lack of living up to the hype (yes, they even used the word 'hype' describing the promise of cloning, earlier in the report) and therefore even less likelihood that further experimentation would be approved in Australia.

Recommendation 3: (by majority) The provisions in the current legislation regarding SCNT should not be amended.

However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT research in animals and humans. The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT.

One wonders why they lack the ethical rigour to admit that cloning has failed the test of 'compelling promise and necessity', but McGovern makes that point with great strength straight after the Committee's majority comment. Read and admire this from McGovern:

The foregoing represents a majority view of the Review Committee. Reverend Kevin McGovern, however, notes:

The approach recommended by the Lockhart Review, which stated that ‘the greater the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified.’ Reverend McGovern believes that in 2011 the latter standard has been reached for SCNT. In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT?

Some scientists have proposed some possible benefits of SCNT, but their arguments are not entirely convincing. Dr Megan Munsie argues that SCNT-ES cells might more closely resemble ES cells than iPS cells. However, the evidence from animal work is that SCNT generally produces damaged or abnormal embryos. This strongly suggests that even if SCNT-ES cells more closely resemble ES cells, these SCNT-ES cells will still be genetically abnormal and inferior to ES cells. Professor Bob Williamson advocates SCNT to generate stem cell lines as disease models to study late-onset conditions. It is not clear, however, why SCNT-derived lines would be more useful than iPSC- lines. Beyond that, there is only the possibility of what ‘might’ be learnt if research into SCNT continues. The proposed benefits of SCNT research therefore seem not entirely convincing, sometimes rather small, and largely theoretical. On the other hand, SCNT involves the most profound of ethical concerns. It is the creation of human life which will be used in research and then destroyed. When people understand this, many people within the community are troubled by SCNT.

For all this, however, this most serious of ethical concerns has been judged less significant than the mostly theoretical benefits which might come if research into SCNT is allowed to continue. With this outcome, Reverend McGovern wonders whether the ethical concerns about SCNT research are ultimately being given anything more than lip-service.

Perfectly stated. If the Minister had done what was required of him by statute and tabled the Report on the 27th May when it was put on his desk, I know Senator Guy Barnett for one would have brought this passage of penetrating argument by McGovern to the attention of fellow Senators. The case for cloning now is so diminished that it could never carry a conscience vote like it did in the hysterically hyped days of 2006.

That, I suspect, is why the dominant players in this Review Committee have opted for the small target strategy, not moving any controversial amendments (other than on IVD gametes - more planned for a later post) and therefore not provoking the Senate to pay any real attention to the existing legislation. Likewise, the Minister's failure to table the Review in May - despite questions from at least one outgoing Senator, as I recall - is part of a small-target strategy of his own.

Perhaps that means the vile project of creating human embryos solely with their exploitation and destruction in mind will linger as a stain on the statues until a change of Government. So be it. For now, cloning is in terminal decline since the advent of iPS, and its futile life-support will indeed be switched off by a more morally serious Government in due course...

Lung stem cell? Promising, but no reason to take up smoking again...

2011-05-12T13:07:00.000+10:00

Very interesting article today in the New Engalnd Journal of Medicine identifying another native adult stem cell, this time resident in the lung:

Human lungs contain identifiable stem cells. In animal models, these cells participate in tissue homeostasis and regeneration. They have the undemonstrated potential to promote tissue restoration in patients with lung disease.

For those without a subscription to NEJM, see the write-up in Forbes.

Very promising as a potential pathway for regeneration of damaged lung tissue.

NHMRC CLONING REVIEW DUE TO REPORT TO PARLIAMENT 27th MAY 2011

2011-03-28T16:21:00.002+10:00

Thanks to all who made a submission to the Cloning Review (see Blog entry for Feb 15th).

The large majority of submissions argued against cloning, in light of the new, ethical alternative.

Read all the submissions at: https://legislationreview.nhmrc.gov.au/public_submissions

You can listen to our National Director's comments HERE in an online interview.

The concluding remarks in the submission by Australians for Ethical Stem Cell Research:

I trust that we have made the case that the scientific landscape of stem cell science has changed so dramatically since November 2007 that the argument about the ‘unique necessity’ for cloning no longer applies; that if our Senators and MPs had known in 2006 what we know now, cloning would never have been permitted. Arguments for SCNT/cloning are now marginal: its proposed role in mitochondrial disease is demonstrated here as a conceptual error, and the call to create cloned ESCs as a ‘comparison’ to iPSCs, even though we know ESCs are functionally identical to iPSCs, is truly clutching at straws. A sense of proportion – measuring the substantial ethical barrier to the creation of human embryos as mere research material, versus the shrivelled residual arguments for SCNT/cloning – should result in recommendations to repeal this inhuman and unjustified practice.

Our submission online at the Cloning Review

2011-03-16T15:00:00.002+10:00

The Cloning Review Committee is posting yesterday's last-day-rush of submissions, including ours, to the legislative review site. There are many well worth a read, over a good red one night this week...

Ours is at the link: https://legislationreview.nhmrc.gov.au/submission/submission-165 and opens with a line of argument tediously familiar to anyone who has followed this blog since 2009, and its predecessor, the pre-Yamanaka, "Conscience versus Con Science" since 2006:

Summary statement

SCNT/cloning is a human corruption and a scientific failure. It is unethical, in that it involves the creation of living human embryos solely for research and destruction. It is unnecessary, in that the stem cell revolution of 2007 has removed the sole scientific argument for cloning: SCNT/cloning is no longer the “unique method” for obtaining patient-matched pluripotent stem cells, in fact it has never obtained even a single human stem cell for all the millions spent and all the embryos created and destroyed. The new “induced pluripotent stem cell” (iPSC) technique has succeeded magnificently in achieving patient-matched pluripotent stem cells where cloning has failed. Further, the iPSC method is ethically uncontentious: it does not use women’s eggs and does not create and destroy human embryos. This Review Committee should recommend repeal of the unethical practice of SCNT/cloning - a practice which since 2007 has no plausible justification - and recommend restoring the long-standing prohibition on the creation of human embryos solely for research.

Action! March 15 Deadline to say NO to human cloning...

2011-02-15T17:34:00.007+10:00

We only have until March 15th to tell the federal Cloning Review that we want this inhuman and unjustifiable science banned once again. Please see https://legislationreview.nhmrc.gov.au/2010-legislation-review for ‘how to make a submission’.

Background:In 2006, by just one vote in the Senate, a law was passed allowing human cloning – the creation of living human embryos solely for the purpose of research and destruction. The law bans the cloned embryo from being implanted in a woman’s womb, and decrees that the embryo must be destroyed before 14 days of age, but still permits the creation of embryonic human life solely for exploitation in stem cell experiments and IVF research.

That was wrong and unnecessary then, and even more unnecessary now – since the magnificent breakthrough by Yamanaka in November 2007 of ‘direct reprogramming’ of adult skin cells into the exact equivalent of embryonic stem cells, without ever creating or destroying a human embryo. This revolution in stem cell science means that scientists now have an entirely ethical method to obtain the specialized stem cells that cloning hoped to obtain but never has obtained. Cloning is a failed science; the new Yamanaka method has proven both simple and effective.

Reading:To get the latest on why cloning is both wrong and redundant, read my review article from Viewpoint magazine, “An Obituary for Human Cloning”. And browse this blog for some highlights of the new world of entirely ethical stem cell science - where there is no need for cloning.

Action:
Then please write a submission, however short and simple, to the committee. All we need to convey is that:

· It is wrong to create human embryos solely for research and destruction.
· We understand that cloning (SCNT) is one method of creating a living human embryo, as was confirmed at the Senate hearings in 2006 – the same method used for creating Dolly the sheep.
· We know that, since the Yamanaka 'iPS cell' breakthrough in November 2007 (see my review article) we have an entirely ethical, and proven, method of obtaining the specialised stem cells that cloning hoped (but failed) to obtain, so there is no longer any serious justification for cloning.
· If our Senators had known in 2006 what we know since the Yamanaka breakthrough, cloning would never have been considered, and no laws would have been passed.
· We now want the Review Committee to acknowledge the dramatically changed scientific landscape, and recommend to Parliament that the provisions allowing cloning are no longer scientifically justified, and should be repealed.

As always, the committee is dominated by well-known supporters of cloning (see my December entry on 'Cloning review at last'). That is a disgraceful derailment of a supposedly 'independent' review. However, that is not our primary concern. We need to send lots of careful, thoughtful submissions - even a short summary statement is fine, and there is no need to provide responses in all sections of the review - so they know that the public is aware that the old arguments for cloning no longer apply, that it is now a redundant science supported by unjustifiable laws.

FURTHER COMMENTS by our WA Rep: In 2002 the Commonwealth passed laws permitting research on so called “left over” human embryos but banning the deliberate creation of human embryos for research by any means, including a comprehensive ban on the cloning of human embryos.

A 2005 review of that legislation proposed revoking the ban on cloning and allowing human embryos to be created for research by cloning or by the use of eggs derived from aborted baby girls. Legislation implementing the changes passed the Senate by just one vote. It was given Royal Assent on 12th December 2006.

All states except Western Australia subsequently passed mirror legislation allowing cloning. In WA note was taken of the revolutionary developments in science in November 2007 which allowed pluripotent stem cells to be derived from any body cell by a process which avoided any creation or destruction of a human embryo.

Only Sydney IVF has been issued with licenses to experiment on cloning. Since obtaining the licenses on 16 September 2008 Sydney IVF has used 389 “clinically unsuitable” human eggs (ova) in an attempt to create cloned human embryos. In only 32 attempts was there development to the two cell stage and in no case was the eight cell stage passed. This is well short of the point at which embryonic stem cells could be extracted. The official report on the experiments states: No reproducible method for SCNT [somatic cell nuclear transfer] using clinically unsuitable eggs for the efficient epigenetic reprogramming of human embryonic stem cells to the blastocyst stage has been established to date.

It seems futile to be trying to clone using eggs that are no good at being fertilised. This approach was tried and abandoned by British researchers at Newcastle some years ago. They switched to using fresh, good quality eggs obtained through an egg sharing arrangement with women undergoing IVF at half price rates – a form of payment for eggs.

This approach is currently banned in Australia.

In July 2009 review committee member Loane Skene called for Australia to follow the lead of New York State which broke ranks in the US by allowing payments to women for eggs for research. It seems likely Skene will seek to persuade the committee to recommend this change.
Inducing ovulation in women in order to harvest their eggs exposes them to a massive 239% increased risk of uterine cancer, 150% increased risk of non-Hodgkin’s lymphoma and a 42% increased risk of breast cancer.

Up to 10 percent of patients undergoing induced ovulation experience severe ovarian hyperstimulation syndrome (OHSS) with symptoms including loss of future fertility, kidney or multiple organ failure, and death. Deaths from OHSS include 32 year old Irish woman Jacqueline Rushton, who died in Dublin on 14 January 2003. She suffered a gradual deterioration of her organs, virtually all of which were slowly destroyed. Temilola Akinbolagbe, a young woman who died in April 2005 in London, suffered a more sudden death from a massive heart attack linked directly to OHSS.

You are encouraged to make a brief submission to the legislative review:
- opposing any proposal to allow payment for human eggs for cloning research;
- calling on cloning to be banned because it is a failed approach to obtaining stem cells for therapy and it involves the unethical creation and destruction of human embryos.

Submissions can be made online at: https://legislationreview.nhmrc.gov.au/node/add/submission

Hard copy submissions may be mailed to: Legislation Review, National Health and Medical Research Council, GPO Box 1421 Canberra ACT 2601

Nice in Mice: skin straight to heart cells (forget embryos)

2011-01-31T16:05:00.002+10:00

I can’t improve on my comrade David Prentice’s coverage of this latest bit of Direct Reprogramming Wizardry. I wonder if this new way of obtaining perfectly-matched stem cells (with no need for embryos or cloning, and apparently minimising the risks inherent even in iPS cells) will generate the sort of science-media interest that the futile tinkering at Geron generated...

Changing Skin Directly to Beating Heart Cells
by David PrenticeJanuary 30, 2011 http://www.frcblog.com/2011/01/changing-skin-directly-to-beating-heart-cells/

Scientists with the Scripps Research Institute have directly converted adult mouse skin cells into beating heart cells, without using any stem cell intermediate, and without the laborious process of generating embryonic-like stem cells. Using a reprogramming process similar to that for induced pluripotent stem (iPS) cells, they were able to directly produce “spontaneously contracting patches” of heart cells in the lab. The research is published online in Nature Cell Biology.

The group used the same four genes (“Yamanaka factors”) often used to make iPS cells, but switched off the gene activity after a few days, before the cells had a chance to become iPS cells. Then they stimulated the cells with factors to direct them into becoming cardiac-type cells.

According to Dr. Sheng Ding, senior author of the study:
“In 11 days, we went from skin cells to beating heart cells in a dish. It was phenomenal to see.“This work represents a new paradigm in stem cell reprogramming. We hope it helps overcome major safety and other technical hurdles currently associated with some types of stem cell therapies.”

The worrisome type of stem cells is pluripotent stem cells, i.e., embryonic stem cells, which have a propensity to grow out of control and form tumors.

Back in 2009, similar story titles (converting skin to beating heart cells) appeared when a group used skin cells to make human iPS cells (pluripotent, embryonic-like stem cells), then turned those iPS cells into cardiomyoctyes in culture. But because of the embryonic-like nature of iPS cells, their practical application for patient transplant is in doubt. When pluripotent cells are injected in mice, they cause cancer-like growths.

Direct reprogramming, going from one cell type to another without forming a pluripotent stem cell, offers a way around the practical problems of pluripotent stem cells. Several other groups have shown the possibility of direct reprogramming to form various tissue types.

Meanwhile, adult stem cells have already successfully treated patients with chronic heart failure.

Cloning Review at last! If you didn't laugh, you'd cry

2010-12-22T15:07:00.034+10:00

This is part disgrace, part farce. A Review that is only announced a few days after the final date at which the statutory report was meant to be completed and tabled (i.e. within four years of the date of Royal Assent which was 12th December 2006); a Government Minister who does not appear to know the effect or subsequent history of the legislation to be reviewed; a new Committee of Review featuring the architect and chief activist of the last Review! What a display of government amateurishness, and what a shamefully cynical process for conducting a new Review on such a contentious matter.

Here is the release from the Federal Minister for Mental Health and Ageing, Mark Butler, and the poor bloke can't get much right. Take this, for instance:

The Acts, passed by the Australian Parliament in 2002 and followed by complementary state and territory legislation, banned human cloning...

No, Minister. For the record, the Acts from 2006 were not followed by complementary state legislation, at least in Western Australia, because that enlightened State (early 2008) rejected the federal laws in the light of the recent Yamanaka breakthrough in 'direct reprogramming' (in Nov 2007) that rendered cloning redundant. And let's cut the weasel words that the Acts "banned human cloning". The whole point is that they allowed human cloning - go ahead and create as many embryonic humans as you like, just do not let the cloned human embryo be brought to birth. Hence the title "Prohibition of Human Reproductive Cloning", i.e. live-birth cloning. There is no prohibition on cloning, provided the embryo is destroyed in research prior to 14 days of age. Create, but be sure to kill, or you will have broken the law under this Act. Nice, that.

As to the makeup of this committee: shame, shame, shame... As mentioned, Prof Loane Skene, Chair of the last Review (the Lockhart Committee) and a leading lobbyist for cloning, gets a guernsey again: how sweet to get to review her own handiwork, since the 2006 legislation is almost verbatim the recommendations of her Committee. And not only that - she has gone into print as recently as October this year, in the peer-reviewed journal of public affairs, Viewpoint, stating that the current cloning laws are not needing any changes. How prejudiced can a review Committee member possibly be!

Well, a close second for publicly-stated prejudice is the sole scientist on the Review Committee, Prof Ian Frazer. He has been an outspoken activist in favour of cloning, and used the full authority of his role as "Australian of the Year" in 2006 to lobby MPs and Senators. He wrote an influential and, in my view, gravely misleading letter on that letterhead to MPs and Senators on the eve of the vote in 2006 on the current legislation. His letter systematically rebutted the case our association had put to the Parliament (including a full page national newspaper ad only days earlier) as to the superiority of adult stem cells and the hype over embryonic stem cells and cloning.

Most outrageous was his claim in the letter that the problem of tumour formation (which in truth is the fatal flaw in embryonic stem cell / cloning science and not a clinical problem at all with adult stem cells) is really a problem with all stem cells! "Any potential for cancer formation would be inherent to stem cells from any source (adult or embryo)", he writes. So there! A pox on both their houses, says this authoritative scientist! Load of nonsense - the truth is that tumours in embryonic stem cell experiments are an accepted and expected problem, while adult stem cell experiments are notably free of tumours. Even the International Society for Stem Cell Research acknowledges (paragraph 2) that "embyonic stem cells themselves cannot directly be used for therapies as they would likely cause tumors" - but that problem does not apply to adult stem cells. Either Frazer does not understand this central, highly practical problem in embryonic stem cell science, or this was a deliberately misleading message sent to MPs and Senators on the eve of the vote - effectively countering our truthful argument that only adult stem cells could be safely used in direct treatment, as only adult stem cells were safe from the risk of tumours. And now he is on the Review Committee!

In our national newspaper ad we had stated, correctly: "Embryonic stem cells remain unproven in animals and unusable in humans - for reasons such as tumour formation - while our own adult stem cells are safely used in many human conditions." By way of rebuttal Prof Frazer claimed, astonishingly, that "there are no therapeutic uses of stem cells (whether embryonic, adult, or generated by nuclear transfer)". His claim set the B-S metre swinging wildly, given that by late 2006 we had hundreds of patients showing therapeutic benefits from adult stem cells - admittedly early and often small-scale, but certainly 'therapeutic uses' - in a wide range of conditions, including heart disease, wound repair, corneal repair, auto-immune disease. And of course exactly zero with embryonic stem cells. Again, a more truthful statement confirming that there are, and were, adult stem cell therapies, is found at the ISSCR site (paragraph 3) - referring to conditions and trials that were published before Frazer wrote his letter to Senators:

The range of diseases where stem cell treatments have been shown to be beneficial in responsibly conducted clinical trials is still extremely restricted. The best defined and most extensively used is blood stem cell transplantation to treat diseases and conditions of the blood and immune system, or to restore the blood system after treatments for specific cancers. Some bone, skin and corneal diseases or injuries can be treated with grafting of tissue that depends upon stem cells from these organs. These therapies are also generally accepted as safe and effective by the medical community.

But 'these therapies' were flatly denied by Frazer in his letter to Senators on the eve of the vote. Frazer's was a muddled as well as misleading claim about 'no therapeutic uses', given that later in his letter he acknowledged therapeutic uses for adult stem cells in bone-marrow transplants, but it was certainly effective in persuading our representatives that our side of the debate was wrong and they had better allow "all avenues of research" to proceed. On any honest comparison of the actual science versus what he gave our MPs to believe, how is that intervention not an abuse of his authority as "Australian of the Year", in my view misleading our elected representatives on the very eve of the vote? And how then is such a politicised scientist considered suitable as the sole scientific member of this 'independent' Review Committee?

He concluded his "Australian of the Year" letter to MPs and Senators with as shameless a piece of emotional arm-twisting as I have seen, playing the 'sick child' card:

The decision you make... has the potential to impact on the quality of medical treatment our children receive. Will our children look back in 25 years and say "Our parliamentarians made the right decision, that gave us access to cures for diabetes, heart disease, and neurological disorders", or will they be forced to travel to the US, Europe and Asia to seek treaments?

I have no problem with a known cloning advocate like Frazer being on the committee, as long as his influence could be balanced on the committee by a scientist of equal standing, somebody who could challenge his dubious factual claims - but there is nobody. From Queensland we have an expert in the ethics of midwifery! What earthly use is she on a cloning review committee - unless she wants to upgrade the legislation to allow live-birth cloning so she can expound on the ethics thereof? In Queensland we have giants in the field of stem cell science, like Prof Alan Mackay-Sim or Prof Peter Silburn, so why not put them up there with Frazer? Aha! But they are likely to bring some rigour to bear on the actual facts of stem-cell science, especially post-Yamanaka, and at times have exhibited the personality disorder of 'cloning scepticism', and that would never do! In Victoria we have one of the most senior research scientists in the country, and an expert on stem cells where Frazer certainly is not - Prof TJ Martin - who would have been the obvious choice for this Review, if sound science was the true objective. But no, Victoria gives us the lawyer and serial committee activist, Skene.

This committee is, like its predecessor, another cynical exercise in getting the Report that the "just research everything and who gives a damn about human embryos" lobby desires. Good luck to the token Catholic ethicist on the Committee, but because he has no other scientist on the committee to challenge the well-established views and advocacy of Prof Frazer and Prof Skene, I suspect his voice will be drowned by the noise of the committee's big guns.

Or will Frazer and Skene astonish their critics and prove to be objective and balanced about the diminished place of cloning in the new era of stem cell science? Will they acknowledge that the one great argument for cloning in 2006 - that SCNT was the only way to obtain specialised pluripotent stem cells that exactly match the patient - is no longer a valid argument (post-Yamanaka, in the new era of iPS direct reprogramming)? Will they accept that, had we known in 2006 what we know now, no legislation on cloning would ever have been drafted, let alone passed on the floor of Parliament?

Therefore, will they have the grace to conclude that this divisive practice of cloning, which in the view of many desecrates human life and violates the profound meaning of human reproduction and relationships, is no longer justified and can now safely be repealed in favour of the non-contentious iPS alternative? Please, please, let it be so.

Giving the tale of two-dad-mice a miss

2010-12-15T23:04:00.003+10:00

Just a bit of idle mutilation by scientists who were once little boys pulling wings off butterflies. This creepy step is not coming anytime soon (or distant) to a gay couple near you, for the same pesky reasons of human complexity that have foiled the cloners of men rather than mice.

Try the Wall St Journal for an outline of this "weird" experiment (to use the word of the principal mutilator); or get as much explanation as you would ever need from Dr David Prentice at his FRC blog.

Ah yes - the other 'ESC' treatment!!

2010-11-29T17:36:00.008+10:00

After Geron Corp and the non-ESC non-treatment trial in spine inury, I see that Advanced Cell Technology (ACT) has made its own bid for five minutes of fame, this time with a rare form of macular degeneration (Stargardt's macular dystrophy). Five minutes is all it takes for intelligent people to ask the same questions I posed re Geron:

1. Given that we can do all this with adult stem cells (for example, see HERE) why mess with embryos (with their inherent problems of tumours, and immune supression, let alone the ethical ugliness)?

2. Even if you really really really want to use tumorigenic pluripotent stem cells, why not spare the patient the need for immune suppressant drugs and use iPS cells (for example, see HERE) as a source of the transplatable cells - because they at least match the patient?

What mug would turn away from the obvious advantages using safe, genetically perfect ASCs and instead use dangerous pluripotent cells? And if only the latter "will do", what mug would use 'foreign' ESCells when he could use genetically matched iPS cells? For as the old song goes: "Anything 'e' can do, 'i' can do better" especially when it comes to matching the patient's immune system.

Still, if all your company's resources and IP is tied up with embryos, and the FDA is fool enough to grant your reckless and unjustified experiment on human subjects, and your legal liability is sufficient - then it is understandable (although still unjustifiable) that you would proceed with ESC-derived cells.

Hype-alert: as with Geron so with ACT, not a single ESC will ever be injected into a patient (despite the breathless headlines in the media) because, of course, you can never do that. Likewise, this ACT trial is not a treatment: is is just a phase 1 safety trial to see what harm the ESC-derived cells might do to the subjects. So while it is understandable for the CEO to talk up the company's trial, it is not as he puts it "a game changer for the medical community". The only game changer will be when steady minds and smart investment finally expose this embryo-tinkering for the redundant stunt that it is. Then we can divert our energies to the two fertile fields of stem cell research: ASC for safe direct therapies and iPS for ethically uncontentious genetic research and drug development.

My review article on the Death of Cloning

2010-11-29T17:24:00.002+10:00

For a glossy summary of why cloning is a blighted science, and why our Parliaments can and must remove the legislation that underpins cloning, here is a link to my peer-reviewed article in the latest edition of 'Viewpoint'. This is a public-issues journal put out by the Australian Christian Lobby, and features a pair of opposing opinions - in this case the other side was put by Professor Loane Skene, former Chair of the Lockhart Review Committee which recommended cloning to the Federal Government back in 2005.

To read her article, and all the other valuable material in the October edition of Viewpoint, please buy one, or a dozen and give them to friends for Christmas, via http://www.viewpointmagazine.com.au

As for my article, feel free to circulate - but mention Viewpoint as the source, thanks.

Turn skin cells to buckets of blood cells – and forget embryos

2010-11-09T18:12:00.002+10:00

Something funny happened on the way to reprogramming a patient’s skin cell to an iPS cell. An astute observer at McMaster’s University, Canada, noticed that some of the cells did not fully reprogram, and the half-baked cell had that donut-look of a red blood cell. Now they have learned to control this partial reprogramming, and the McMaster’s news release yesterday tells the story:

Making blood from skin does not require the middle step of changing a skin stem cell into a pluripotent stem
Hamilton, ON (November 7, 2010) – In an important breakthrough, scientists at McMaster University have discovered how to make human blood from adult human skin.
The discovery, published in the prestigious science journal Nature today, could mean that in the foreseeable future people needing blood for surgery, cancer treatment or treatment of other blood conditions like anemia will be able to have blood created from a patch of their own skin to provide transfusions. Clinical trials could begin as soon as 2012.

Mick Bhatia, scientific director of McMaster’s Stem Cell and Cancer Research Institute in the Michael G. DeGroote School of Medicine, and his team of researchers have also shown that the conversion is direct. Making blood from skin does not require the middle step of changing a skin stem cell into a pluripotent stem cell that could make many other types of human cells, then turning it into a blood stem cell.

Samuel Weiss, professor and director, Hotchkiss Brain Institute, University of Calgary, said: “This groundbreaking work from Mick Bhatia’s lab is both fascinating and important. It heralds a new age by discovering a role for ‘directed differentiation’ in the treatment of cancers and other disorders of the blood and immune system.”

Yet the ABC cannot help itself. Reporting on such a compelling breakthrough using our own adult cells, it still has to perform a wanton genuflection to those embryonic wannabes. Having established that the Canadian technique does indeed produce human blood cells that exactly match the patient – the authentic pot of gold at the end of the stem cell rainbow - and does it without messing with eggs, embryos or cloning, ABC reporter Jennifer Macey still has to get the token wet-blanket scientist to say that “unlike embryonic stem cells, which can produce millions of new cells, it's still unclear whether the adult skin cells will be able to produce enough blood.”

Yeah, right – show us a single embryonic stem cell that can produce even a single red blood cell that matches even a single human patient. There is none. Zero, zip. To achieve such a cell you first have to successfully clone the patient into her twin embryo, extract the embryonic stem cells, and then differentiate those ESCs into a blood cell. What utter folly. What an insult to our intelligence, pretending such a futile embryonic pursuit deserves equal billing with direct reprogramming of adult cells. It is time for pro-cloning scientists to get over their wounded pride in backing a dud science, stop wasting our hard-earned tax dollars, and stop pretending to ABC journalists and others that cloning is anything but an expensive and offensive failure.

Meantime, let the magnificent work on the near-alchemy of ‘directed differentiation’ proceed apace.

Time to con the pollies again: a cutting-edge cloning project!

2010-10-16T13:51:00.005+10:00

And then there is the other story in the SMH today - License sought to make cloned human embryos

Passing strange that the chaps in Melbourne should wait until a month before the next federal legislative review is due, and then make their exciting announcement of a cloning trial. Just too caught up with other things since 2006? Bit busy; perhaps discouraged that their colleages in Sydney (and the rest of the word, for that matter) have not been able to get a single stem cell from their cloned embryos? Obviously nothing to do with fabricating a sense of significance around this redundant science in time to dupe the MPs yet again.

Fooled by hype and emotional blackmail ("how dare you stand in the way of a cure for my ...insert disease category.... child!") in 2003, browbeaten by emotional blackmail and hype in 2006 - yes, it is entirely possible that the MPs will again go supine before the solemn claims of scientists that "we really need to research everything" if we are to make the lame to walk and the blind to see.

No, for once, dear representatives, get clear that this science is not only a vile corruption of our humanity - intentionally creating embryonic human life for the sole purpose of destructive research - but is as dead and dated as Dolly. We are in a magnificent new era, the era of Yamanaka's iPS direct reprogramming, where the exact stem cells that cloning hoped to obtain, but never did, have now been obtained in spades by an ethically uncontentious method. Cloning has lost the only justification it ever had, and the one serious argument that got it past the Parliement in 2006.

Again, this article from the SMH's science reporter has some rigour in not dodging the nature of cloning - as the making a a living human embryo with the sole purpose of research . Note the correct description in the article:

In this procedure a person's DNA would be put into an egg to produce a days-old
cloned embryo from which embryonic stem cells could be extracted.

Some sound reporting on the Geron experiment

2010-10-16T13:36:00.005+10:00

Deborah Smith of the Sydney Morning Herald is a specimen of that rare species: a well-researched science reporter. It says a lot about general reporting on stem cell science that an article like today’s, below, should come as a pleasant surprise for its sober and careful presentation - and not only because this association gets to put its case.

An informed reader could quibble re no mention of the published ASC alternatives for spinal treatment, and re inadequate explanation that ANY experiment conducted with Geron’s ESC derivatives could be more profitably conducted with iPS derivatives, and likewise fall about laughing at the Prof from another planet who calls this Geron-come-lately non-event "the dawn of the Stem Cell age" - but overall it meets the requirements for intelligent scientific/bioethical reporting.

A race from lab to patient
Date: October 16 2010
Deborah Smith

The first test of an embryonic stem cell therapy in humans has left even the fiercest advocates nervous, writes Deborah Smith.

''IT'S been a long time coming,'' says Joanna Knott, chairwoman of SpinalCure Australia, about the ''exciting'' news that the world's first clinical trial in people of a human embryonic stem cell therapy has finally begun in the US.

Professor Andrew Elefanty, a stem cell researcher at Monash University, disagrees. ''I think history will judge it has been very fast.''

It is only 12 years since human embryonic stem cells - the immortal, master cells that can be converted into 200 different types of tissue - were first extracted from donated IVF embryos. Now cells derived from them have been injected into a person with severe spinal injuries in Atlanta. From lab to patient in just over a decade is ''truly rapid progress'', Elefanty says.

Dr David van Gend, an opponent of embryo research, however, says the trial by US company Geron Corporation is unnecessary and dangerous. ''It is an uncertain experiment, which has got even proponents of embryonic stem cell research worried.''

READ MORE...

Scientist re Geron: "My gut feeling is that it's a scam"

2010-10-16T10:19:00.001+10:00

Now I think Michael Fumento, writing at AOL, is too kind to Geron – but here is his take “in the wake of Geron Corp.'s ballyhooed experiment, which, while it's unlikely to do much to advance health, could do a lot for Geron's financial prospects.”

Thumbs up to the neuroscientist quoted herein: "My gut feeling is that it's a scam," he said.

Read on at http://www.aolnews.com/opinion/article/opinion-geron-corp-stem-cell-news-is-more-hype-than-science/19673060

Geron's futile fiddling finally approved

2010-10-12T21:42:00.008+10:00

So the FDA has blinked, and the first patient has finally been injected with Geron's dubious nerve cells derived from IVF embryos. The race is on to see whether the immune suppressive drugs (required to induce tolerance of the foreign embryo's cells) or the still-risky cells themselves cause greater harm to these poor desperate individuals.

The media, true to form, sit at the feet of the embryo-cell masters, and accept uncritically whatever is spun at them. So, in the premier current affairs programme in Australia, the ABC AM radio show this morning, journalist Kim Landers reports:

“At a hospital in Atlanta, doctors have injected embryonic stem cells into a patient's damaged spinal cord.”

No, they have not. No ES cell (whether from IVF embryos or from cloning - and for that matter no iPS cell) can be put into a human being, because they form teratoma tumours in animals. For ‘authoritative confirmation’ of this fact, see the statement on the ISSCR web site (‘Top 10 Things to Know about Stem Cell Treatments’ at point 2):

“embryonic stem cells themselves cannot directly be used for therapies as they would likely cause tumors”.

Only adult stem cells can be put into humans, and have been in large numbers, because they alone are stable and safe in vivo.

Correct reporting would be that the Geron Corp ES cell trial in spine injury would NOT put a single ES cell into any patient; it merely uses ES cells (from IVF embryos) to generate “mature” (but genetically foreign) nerve progenitor cells for transplant. But here are the obvious questions:

o Since the same nerve cells could be readily generated from induced pluripotent stem cells ( iPS cells), with the huge advantage that they would exactly match the patient – and therefore not require immune suppressant drugs - why use embryos at all?

o Since scientists have already published trials using a patient’s own adult stem cells in spinal injury, with no tumours formed, and without requiring immune suppression drugs which the Geron study does require – why use embryos at all? [i]

Surely that is worth asking .

Kim Landers continues: “In phase one of this trial, doctors will establish only whether the treatment is safe to use. Geron will need to do more trials in the coming years to assess whether the treatment is effective in repairing spinal cord injuries.”

Correct, but not enough said to debunk the unjustified hype from Geron. There is still a concern that the “mature” stem cells in this trial may revert to ES cell status and cause tumours – that is why the FDA has for years equivocated over the proposal. In fact Geron has already said they will have to monitor the patients for 15 years to assess the danger.

The trial is only a Stage 1 test to see if tumours occur. It is not even pretending to be a ‘treatment’ – it is an uncertain experiment which has got even proponents of embryonic stem cell research worried that it could all be a rash miscalculation and backfire terribly.

Kim Landers: “In a statement, Geron's president and CEO, Thomas Okarma, describes this trial as a, quote, "milestone for the field of human embryonic stem cell based therapies".

Well he would say that… But what use is a milestone in a dead-end street? Cells from embryos are redundant in the era of direct reprogramming - iPS technology. ESCs cannot be used directly in humans, unlike ASCs; ESCs are foreign to the patient, unlike iPS cells, and are therefore of limited use even for research; iPS cells are easy to obtain, and ethically uncomplicated, whereas the Geron cells are only obtained from stripmining embryos.

Finally, for your entertainment, revisit the comical history of Geron announcing its ‘milestones’, usually corresponding to a temporary rise in their share price...

What an investment!

[i] Link to Adult Stem Cell Spinal Cord Trials:
http://www.nature.com/sc/journal/v47/n10/abs/sc200924a.html and http://www.ingentaconnect.com/content/cog/ct/2008/00000017/00000012/art00001?token=0057156e9168a7e442f20672148766c777b492b45427a63687627504541676249266d656c185ee1dce5572d and http://www.media.wayne.edu/2009/10/16/study-shows-adult-stem-cell-grafts-increased

Another cloning guru drops it for iPS

2010-07-06T18:33:00.001+10:00

From this week’s Nature Medicine interview, with former cloning advocate Prof George Daley, my favourite passage is this:

“Q: Had you been working on cellular reprogramming before Shinya Yamanaka
reported the first mouse iPS cells in 2006?
A: Yes, I’d been thinking about reprogramming since the late 1990s, when I started to consider using embryonic stem cells to make customised cell therapies. That initially took the strategy of using cloning, though we never made human nuclear transfer effective… Once Yamanaka solved the problem, I turned around virtually my entire programme to take advantage of that breakthrough.”

Here is a fuller report on this revealing development, from Michael Cook’s BioEdge site – see http://www.bioedge.org/index.php/bioethics/bioethics_article/9087/

Leading stem cell scientist quietly drops embryonic work
by Michael Cook 3 Jul 2010

Amongst scientists who promoted the use of human embryonic stem cells five years ago, in the middle of passionate debates in the US, Australia and elsewhere, few were more influential in shaping the ethical debate than Harvard’s George Q. Daley. “We must support the vitally important applications of embryonic stem cells to medical research,” he testified to a Congressional committee in 2005.

He contended that work on hESCs was so important that it could not be delayed. It was needed for cures, drug development and genetic research. The fact that years had passed without results made no difference. “The field of human embryonic stem cell research is a mere 7 years old, so it is premature to expect successful cell therapies to have already been delivered to patients.”

Now, he has transferred the same sense of urgency and excitement to an ethical non-controversial alternative to hESC research which he dismissed before the committee – induced pluripotent stem cells (iPS cells). At the time, he said, “Although this strategy is worth pursuing, it is extremely high-risk, and may take years to perfect, and may never work as well as nuclear transfer, which we know we can practice today.”

However, in 2007 iPS cells were developed by Shinya Yamanaka. Professor Daley immediately stopped campaigning for hESCs. In an interview with Nature Medicine, he says, “Once Yamanaka solved the problem, I turned around virtually my entire program to take advantage of that breakthrough.” In language remarkably similar to his 2005 testimony, he now promotes iPS cells: “There's no reason in my mind to think that we're not going to have iPS cells that function as well as embryonic stem cells.” Why haven’t there been any cures yet? “You can't hold the field to too high a standard. It's only been two years, and a lot of this stuff is in the pipeline.” ~ Nature Medicine, June

Can it be?! The official ISSCR line on stem cell science moves nearer ours…

2010-06-30T19:25:00.001+10:00

The times are a-changin' when the International Society for Stem Cell Research (ISSCR), the peak-lobby-group that was scolded in Nature magazine for its disgusting deceit about cloned embryos not really being embryos (let's call them something different, so the public does not take their moral status too seriously), now tells us something close to the truth about stem cell science.

Watch and learn: cynical spin is subsiding in the face of scientific reality, and received opinion is starting to catch up with what we, at this site, have been saying for years.

The ISSCR has launched this month a useful site called "A closer look at stem cell treatments" – ostensibly directed at countering the claptrap about alleged stem cell therapies being flogged on the Internet and in dodgy Indian clinics. This aims to protect the public, who cannot readily judge scientific claims.

If only the ISSCR's own stem cell scientists and media enablers had been as principled about countering earlier claptrap during the embryo stem cell and cloning debates, and about protecting the public from dodgy scientific claims. Then it seemed fine for politicised scientists like Alan Trounson to parade grossly misleading videos about paralysed rats in order to persuade MPs to vote for embryo research, or for science reporters / cheerleaders like Elizabeth Finkel to drool about 'biological gold' flowing from the (fraudulent) experiments of Dr Hwang, or for the cloning lobby's PR machine to hype mercilessly about the miracle cures that would flow if only MPs would permit us to create and destroy human embryos.

Cloning, as it turns out, is dead in the water, and the value of this ISSCR site is the tacit acceptance that the future of stem cell science lies elsewhere.

Take this bit of straight-talking from the page 'Top 10 things to know about stem cell treatments' – in case any reader has doubted the validity of this site's repeated reminder about the non-usability of embryonic stem cells:

"However, embryonic stem cells themselves cannot directly be used for therapies as they would likely cause tumors and are unlikely to become the cells needed to regenerate a tissue on their own. They would first need to be coaxed to develop into specialized cell types before transplantation."

Any journalist who ever again says that 'embryonic stem cells are going to be given to patients' needs their nose rubbed in that ISSCR paragraph. It is official: ESCs cause tumours, or even tumors, and are unusable in humans. Get that? As this site has so patiently instructed readers, the only semi-safe ESC is not an ESC, but a mature cell like the 'terminally differentiated' nerve cells Geron Corp plans to use in its spinal transplants. However, even these 'terminally differentiated' cells may not be so safely finalised – they may still revert to those accursed little ESCs and cause tumours. That fact of stem cell nature is why the Geron trial has still not been approved, after all these false dawns over a decade.

One sign of the residual spin from the ISSCR is that they still feel obliged to talk up the Geron-type trial, with no acknowledgement that the FDA still does not consider it safe, and it is a standing joke about this trial being "due to start next summer" – see "Geron and on and on…". How lame, at the end of the "Top 10 things to know about stem cell treatments", after understating the genuine adult stem cell breakthroughs, they have to genuflect to Geron's embryonic junk science:

"The first embryonic stem cell-based treatment for acute spinal cord injury is currently under review by the U.S. Food and Drug Administration (FDA) and will hopefully move into clinical trials soon."

Ah, yes, "hopefully soon"… You can fool some of the people all of the time…

Also strange is the ISSCR's petulant refusal to acknowledge the proven plasticity of adult stem cells for research and treatment – their long-established multipotent ability to transform into stem cells of entirely different tissues. Thus a patient of mine with Parkinson's has his olfactory plate (nasal) stem cells sampled in a quick biopsy, which are then transformed at Brisbane's National Adult Stem Cell Centre into other types of stem cells, capable of creating the cells of one's choice – say liver cells, or cardiac muscle cells, besides the obvious application of creating neural cells for Parkinson's research.

Still the ISSCR 'Top 10 things' page, under 'point 1: there are different types of stem cells' comments disingenuously:

"A neural stem cell won't spontaneously make a blood cell and likewise a hematopoietic stem cell won't spontaneously make a brain cell. Thus, it is unlikely that a single cell type could be used to treat a multitude of unrelated diseases that involve different tissues or organs."

Of course it does not happen 'spontaneously' – but it can happen in a predictable, safe way under the careful guidance of a stem cell scientist - which is the entire goal of stem cell therapy! This, again, is the standard negative spin of the ISSCR – trying to downplay adult stem cell plasticity and usefulness, in order to leave the embryonic alternative looking less shabby by contrast.

Finally, it is worth a look at more of the page on 'types of stem cells' – although the same spin applies re downplaying proven adult stem cell progress. Nevertheless, the ISSCR is straightforwardly acknowledging the non-usability of ESCs unless they are NOT an ESC any more:

"Furthermore, embryonic stem cells carry the risk of transforming into cancerous tissue after transplantation. To be used in cell transplant treatments the cells will most likely need to be directed into a more mature cell type… there are currently no treatments using embryonic stem cells."

On the great iPS breakthrough, there is some fudging – proposing that there are relevant 'differences' from ESCs, without pointing out that all those differences are to the practical benefit of iPS cells versus ESCs as tools for research – and also waffling about the need to refine iPS before they can be used for safe therapies: we argue that iPS cannot be used for therapies any more than ESCs, because they all cause tumours, and it is better to spell that out plainly.

At this authoritative site of the arch-lobbyists for embryonic exploitation, we witness the spin on cloning slowing to a stop, because the science of cloning has lost its bogus momentum; we see the embryonic hype withering on the vine because only adult stem cells are producing the goods with therapy and only iPS cells have achieved the goal of patient-specific pluripotent stem cells for research and drug development.

In as far as this site represents a face-saving move of the 'official' position on stem cell science towards our position, it is cause for celebration.

Sick Kidneys the latest to benefit from adult stem cells

2010-05-21T13:11:00.001+10:00

It is almost embarrassingly simple: gather bone marrow stem cells (not difficult, and not expensive) and squirt them back into a vein – then let them seek out and repair the damaged bits.

And in case I have not mentioned it on this Blog, don't forget that your own adult stem cells do not form tumours, and do not (of course) get rejected by your immune system… Unlike certain dodgy cells culled from an IVF embryo. Which, of course, have not ever been used in humans, for the very reason of tumour formation and immune rejection. But perhaps I had already mentioned that…

Here, in this month's journal Circulation, human adult stem cells (aka HPSCs in this study) do good things to the damaged kidneys of mice: link at http://circ.ahajournals.org/cgi/content/abstract/CIRCULATIONAHA.109.928796v1

"Conclusions – These studies advance human HSPCs as a promising therapeutic strategy for promoting renal repair after injury."

"Ah!" you say, "but didn't they find benefit for mice last year using embryonic stem cells too?" A sincere, if dull-witted question, but I will answer it: yes they did, but why bother? Certainly, in the Journal of the American Society of Nephrology last October, injection of ASCs was found to repair kidney function in Alport's disease, and "Injection of mouse and human embryonic stem cells produced similar results." See http://jasn.asnjournals.org/cgi/content/abstract/20/11/2359 Yes, both types of stem cell worked – but why even bother with those dangerous, and ethically ugly, embryo cells? Is it the tumour-forming powers of ESCs that you most want for your patients, or are you pleased that they would have to take dangerous immune-suppressant drugs?

Now… stay tuned to the new Phase 1 human trials using our own ASCs in kidney repair.

Multiple Sclerosis: safety established – and an early hint of benefit - using adult stem cells

2010-05-13T13:32:00.001+10:00

More solid work from Prof Neil Scolding of the UK, published last week in the Journal Clinical Pharmacology and Therapeutics (part of the Nature group or journals). Here is the link to the abstract: http://www.nature.com/clpt/journal/vaop/ncurrent/abs/clpt201044a.html

It describes a phase I trial (that means establishing that it can be done safely, but not yet establishing effectiveness) of mobilising marrow stem cells from MS patients. Take the marrow sample, and reinject a mix of stem cells into the circulation, to home in on damaged MS plaques in the brain and do some good…

This phase I research should now lead to bigger trials, and refinement of the protocol to maximise benefit.

It does not quite justify the excitement of the newspaper report below, but is still a solid first step in establishing safety and a hint of benefit. And like ASC treatment in diabetes, the key appears to be catching the illness in the early stages, before most of the damage is done.

DvG.

Stem cells raise hope for treatment for multiple sclerosis patients Thousands of MS sufferers could benefit from a revolutionary treatment that injects them with stem cells taken from their own bone marrow.

By Richard Alleyne, Science Correspondent 05 May 2010

http://www.telegraph.co.uk/health/healthnews/7682055/Stem-cells-raise-hope-for-treatment-for-multiple-sclerosis-patients.html

Researchers have long believed that the stem cells could halt and even reverse the effects of the disease by patching up the damaged parts of the brain and spinal cord.

Now British scientists carrying out one of the first ever trials into the procedure believe that they have proved that it works.

The research team, led by Professor Neil Scolding, at the University of Bristol and North Bristol NHS Trust, believe that the treatment has stabilised the condition and shown some "benefits".

"We are encouraged by the results of this early study," he said.

"We believe that stem cells mobilised from the marrow to the blood are responsible, and that they help improve disease in several ways."…

Researchers found that the patients suffered "no serious adverse effects" from the treatment and tests suggested the disease was stable and there had been improvement in the effectiveness of damaged nerve cells.

They showed that the damaged nerve pathways were able to carry electrical pulses more effectively after the treatment.

Now the researchers want to carry out a longer and larger study to see if the treatment can be improved and works consistently.

Professor Neil Scolding said: "The safety data are reassuring and the suggestion of benefit tantalising."

Dr Claire Rice, co-author, said: "The results are very encouraging. We would have expected these pathways to get worse but they have actually got better.

Bone marrow is known to contain stem cells capable of replacing cells in many types of tissues and organs – and so is of great interest to those working to develop new treatments for many diseases, including those affecting the nervous system.

An earlier study on 21 adults in the Lancet also showed that stem cells could halt the progress of the disease and even show some improvement.

The idea is that if caught early enough the stem cells could protect patients from the permanent damage caused to nerve cells and prevent disability.

ESC ‘success’ in mice? Pity about the tumours

2010-03-03T18:44:00.001+10:00

Is this finally some good news for ESCs? Last week we hear that scientists have "successfully used mouse embryonic stem cells to replace diseased retinal cells and restore sight in a mouse model of retinitis pigmentosa." Then reality strikes:

However, complications of benign tumors and retinal detachments were seen in some of the mice, so Dr. Tsang and colleagues will optimize techniques to decrease the incidence of these complications in human embryonic stem cells before testing in human patients can begin.

Yeah, right… Optimise those techniques, decrease those teratomas… Touching optimism by Dr Tsang, the triumph of hope over experience.

Reality check: the very nature of ESCs is to proliferate into tumours, and here we see ESCs acting according to their nature.

The same thwarted hope is there in abstract in the journal Transplantation - excited by the improved electrical response in some mice retinas, but then running aground on the tumours (and retinal detachment):

Although more than half of the mice were complicated with retinal detachments or tumor development, one fourth of the mice showed increased electroretinogram responses in the transplanted eyes.

The no-brainer is that if you want cells to treat human eyes, use human 'adult stem cell' derivatives – as noted earlier on this Blog, at the University of Nebraska for instance – which will not give you tumours.

Again the eyes have it… more success with our own ASCs

2010-01-22T17:37:00.003+10:00

Only just noticed this one, although it was published in Stem Cells online last month.

Another beautiful demonstration of the healing power of our own stem cells – here, patients with limbal stem cell deficiency (LSCD) had some residual limbal stem cells sampled, multiplied in a culture (that excluded any animal products) and reimplanted in sufficient numbers to help regenerate the patient's own damaged cornea. All patients gained better vision and reduced discomfort.

News report from the British NHS, "stem cells restore sight": here
And the full article from Stem Cells (while it remains available on the web): here

The noughties – nought to show for ESCs

2009-12-31T12:52:00.001+10:00

Here is an amusing bit of spin from an ESC advocate "reflecting on a decade of stem cell research" – an end-of-decade review broadcast on the US National Public Radio yesterday.

Note the usual distortion of the science. Because ASCs (adult stem cells) are kicking such great goals in the treatment of actual patients, they do not even get a mention! That would be impolite – a bit like avoiding praising the top student in the class, because it might harm the self-esteem of the idlers.

And although you and I know that ESCs are inherently unusable in humans – thanks to their inherent tumour tendency – Dr Zon of the Boston Children's Hospital merely says that such treatments are "still a ways off". Chuckle. See "Geron and on and on" for an adult version of the end of the rainbow being "still a ways off". However, when the pot of research gold can be gained simply by showing politicians how pretty that rainbow is, never needing to find rainbow's end, you can understand Dr Zon's ever-hopeful fantasy.

The happy moment in this piece comes with Dr Zon's enthusiasm for iPS, which is proving so powerful that the stem cell spin machine is having trouble containing it. So, after consigning ESC therapies to the never never of "a couple of decades" we read:

More immediate, Zon says, is finding new drug therapies using a technique made possible by Japanese researcher Shinya Yamanaka. He found a way to take ordinary skin cells and turn them into cells that behave just like embryonic stem cells, but without destroying an embryo.

When the new technique was announced in 1997 (sic – it was 2007, DvG), stem cell researcher Jose Cibelli of Michigan State University predicted it would revolutionize the field of stem cell research, and not just because it removed the moral quandary of destroying embryos.

"Anybody can do this procedure," Cibelli said. "It's a very simple recipe. It's a combination of three or four genes, and in a couple of weeks you go from a skin cell to an embryonic stem cell. It's remarkable."

The new technique allows scientists to take cells from a patient with a disease, then convert them into these embryonic stem cell-like cells that can grow indefinitely in the lab.

A refreshing bit of truth in a sea of stale platitudes.

As to the closing claptrap about ESC research still being needed to provide the 'gold standard' against iPS – see earlier post. This is fool's gold, and how debased the ESC / cloning currency has become, that instead of being the saviour of little diabetics and old parkinson's patients, it is now merely a 'standard' to measure the real achievers against!

A Happy New Year – and may 2010 see scientific truthfulness and political integrity prevail in Australia. With the review of our cloning laws, the time has come to accept that (post the iPS revolution of November 2007) the scientific justification for cloning no longer exists. The unmitigated abomination of creating embryonic humans solely for research must cease.

DvG.

Heart journal publishes success with adult stem cells

2009-12-02T17:28:00.001+10:00

More good news from the quiet achiever of the stem cell world, the humble ASC.

Here, a rigorously structured human clinical trial in a leading journal shows safety and efficacy with adult stem cells (ASCs) after heart attack – improving objective measures like cardiac output and demonstrating repair of heart muscle in those treated with ASCs versus placebo.

Chuckle… Anybody interested in a trial using those tumorigenic ESCs? Even precious ones derived from a clone of yourself? No? Good decision: it is lot safer to suck a few ASCs out of your blood or marrow and use them – and hey, you have 'done no harm' in the process.

Here is the link to the abstract of the article in the Journal of the Americal College of Cardiology: http://content.onlinejacc.org/cgi/content/abstract/54/24/2277

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Intravenous Adult Human Mesenchymal Stem Cells (Prochymal) After Acute Myocardial Infarction

Joshua M. Hare, MD_*^,_{* et al.}J Am Coll Cardiol, 2009; 54:2277-2286, doi:10.1016/j.jacc.2009.06.055

and here is the link to a commentary in the science pages of the Dr Hare's local paper: http://www.miamiherald.com/news/miami-dade/story/1359195.html

`A PRETTY BIG DEAL'

``This is a pretty big deal. Echocardiograms showed improved heart function, particularly in those patients with large amounts of cardiac damage,'' said Hare, who also is director of the UM Medical School's Interdisciplinary Stem Cell Institute. ``They also had improvements in lung function.''

RESULTS

Patients who received the stem cells were compared to similar patients who received placebo injections. Both were followed by MRI and echocardiogram. After six months, treated patients:

• Were four times as likely to have improved overall condition.

• Were able to pump more blood with each heartbeat than untreated patients.

• Had only one-quarter as many dangerous heart arrhythmias.

• Suffered no toxicity or other serious adverse side effects.

Geron…. and on… and on…

2009-11-16T13:16:00.002+10:00

From the USA, and colleague David Prentice, comes this handy synopsis of Geron Corp's triumph of hope over experience.

This is the company that makes headlines at regular intervals with its imminent human trial of embryonic stem cells – year after share-price-massaging year from at least 2002 (see comedy highlights below).

Hmmm… I am no financial planner, but why would you put money into such a left-behind science? In fact, a science that has never even got started – since there has still never been a single ESC put into a single human being anywhere (because, as we all know, they cause tumours, and do not even match the patient's immune system). If you have stem cell investments (and I do not) put your money where there are already results in human treatments – adult stem cells – or where we have the equivalent of ESCs which do in fact match the patients for research purposes – iPS cells. And leave the embryos unexploited.

For now – jeer on with this commentary from DP:

"Next Year" for Embryonic Stem Cells?

Geron now says that it hopes its embryonic stem cell experiment on spinal cord injury patients might begin in the 3rd quarter of 2010. The original FDA approval to test the cells in patients was given in January 2009 and Geron claimed it would begin in the summer of 2009, but before a single desperate patient had been injected with the potentially-dangerous cells, the FDA placed a hold on the Geron experiment due to safety concerns.

Meanwhile, the obsession with embryonic stem cells has obscured the real hope for patients-ADULT STEM CELLS. Peer-reviewed evidence of adult stem cell success for spinal cord injury patients has already been published by groups in Portugal, in Ecuador, and in Brazil.

With Geron's latest announcement Geron stock rose as much as 12%.

The Geron Prophecies

30 October 2009
Geron expects the data from this study to enable re-initiation of the clinical trial in the third quarter of 2010.

27 January 2009
Geron says that it expects to begin enrolment early this summer at up to seven US medical centres.

20 October 2008
A clinical trial that would test the use of embryonic stem cells to treat spinal cord injury could begin within three months.

17 October 2008
But the FDA is nearing the end of its review process and may lift the hold and allow clinical trials to commence within the next three months, Okarma told The Scientist.

15 May 2008
The Geron Corporation announced Wednesday that its plans to begin the first clinical trial using embryonic stem cells had been delayed by federal regulators. While companies typically do not announce when they submit an application to begin a trial for an investigational new drug, the F.D.A.'s action means Geron must have submitted its application in the last 30 days, Mr. Benjamin said.

12 February 2008
The first experiments using human embryonic stem cells in human subjects could begin within a few months, the chief executive of biotech Geron said Monday. At the annual BIO CEO conference in New York, Dr. Thomas Okarma said Geron plans to start embryonic stem-cell studies in humans with spinal cord injuries toward the end of the second quarter. Okarma said the tests would involve up to 40 human patients, while all prior tests involved rats.

13 November 2007
Geron's development plan for the product calls for the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration and, pending the agency's review, initiation of human clinical trials in 2008.

31 October 2007
Geron, based in Menlo Park, Calif., has been using rats in its experiments of a potential treatment for spinal cord injuries. Geron has already met with the FDA and will submit its plans for human testing to the agency by the end of this year, according to Sion.

20 July 2007
"Geron Corporation in Menlo Park, California, expects to start clinical trials of a therapy for spinal cord injury early in 2008, according to spokesperson David Schull."

9 May 2007
"The first clinical trial of embryonic stem cells is on track to start early next year on patients with spinal cord injury. Geron, the California-based biotechnology company, will carry out the study on accident victims in six trauma centres across the US."

4 August 2006
One company, in particular, Menlo Park, CA-based Geron, is taking the lead in developing experimental embryonic stem cell therapies and hopes to begin human trials next year.

27 July 2006
The company will apply for approval to start US clinical trials in 2007, using glial cells derived from human embryonic stem cells to treat spinal injuries.

17 June 2006
"I'm confident that we will be in the clinic next year with the first human ESC-derived product," said Tom Okarma, chief executive of Geron, at a conference in London last week.

29 March 2006
Tom Okarma: We will complete our IND-enabling studies, which are now in process and still on track, and file our IND during the fourth quarter of this year, assuming the preclinical data continue to go well. That starts a 30-day review clock by the FDA, who then has 30 days to either accept our IND and allow us to proceed or, at that point, they have questions that we must answer before we can begin. We are on track for that. So, assuming they bless the IND, we would hope to be in the clinic in the first quarter of (2007).

7 November 2005
"[R]esearchers at Geron of Menlo Park want to take the next step - in people. They hope to get federal permission to inject those cells into damaged spinal cords. The procedure - which Geron intends to do next year - would be the first human tests of a treatment derived from human embryonic stem cells, the highly versatile body cells that can be coaxed into becoming almost any tissue in the body."

9 September 2005
"Geron plans to begin clinical trials on acute spinal cord injury treatment in early 2006, according to chief executive officer Tom Okarma."

19 April 2005
Thomas Okarma, Geron's CEO, is even less convinced that larger animals are necessary before testing Keirstead's technique in humans. During an interview at the conference, he said he believes the clinical trial could begin in mid-2006.

5 February 2005
"Next year [Hans Keirstead] and his corporate partner, Geron, plan to try treating people who have recent spinal cord injuries, in what would almost certainly be the first human trial of any therapy derived from such cells.

1 December 2004
According to Geron CEO Thomas Okarma, the company is aiming to file an investigational new drug application with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical trials using glial cells derived from embryonic stem cells to repair damaged spinal cords in 2005 or early 2006.

22 February 2004
"The company believes it will be cleared to start the first stem-cell therapy in human tests next year, possibly for spinal-cord injury."

18 March 2002
Keirstead.would ask university officials to seek the U.S. Food and Drug Administration's approval to test the human embryonic stem cells on human patients with spinal cord injuries. Initially, Keirstead said he might be ready to take this step in about a year.

Back from leave… more good news re ‘virus-free’ iPS

2009-10-24T10:21:00.001+10:00

Here it is again – making iPSCs with no genetic material introduced at all, no viral material involved at all (and no ethical violations at all). Yet we will still hear hysterical warnings, in the coming debate over the review of cloning laws in Australia, about how we need to keep creating and destroying embryos because the alternative to embryonic stem cells, induced pluripotent stem cells (iPSCs), are 'dangerous' because they have all sorts of 'viral genetic factors' in them… Watch this space, and watch their lying lips.

It is getting ever-easier and cleaner to make these iPS cells; here we have "the first proof in principles that somatic, or body cells, can be reprogrammed into induced pluripotent stem cells (iPSCs) simply through the influence of the microenvironment in which the sampled cells are cultured." Ethically easier, too, since we leave that embryonic human over there unmolested and use our own, superior, iPS cells. In the usual formulation found in all of these articles: "this would allow us to circumvent ethical issues and the problems caused by the immune system rejecting foreign cells".

Here is the report and the link - the research is published in Stem Cells this week:

Reprogramming a patient's eye cells may herald new treatments against degenerative disease

October 22nd, 2009 http://www.physorg.com/news175458227.html

Scientists have overcome a key barrier to the clinical use of stem cells with a technique which transforms regular body cells into artificial stem cells without the need for introducing foreign genetic materials, which could be potentially harmful. The research, published in Stem Cells, suggests that cells taken from a patient's eye can be "reprogrammed" to replace or restore cells lost to degenerative diseases.

The research, led by Professor Iqbal Ahmad and co-authors from the University of Nebraska Medical Center, is the first proof in principle that somatic, or body cells, can be reprogrammed into induced pluripotent stem cells (iPSCs) simply through the influence of the microenvironment in which the sampled cells are cultured. Until now genetic materials were introduced into somatic cells to re-programme them to become pluripotent, enabling them to generate cells of all three embryonic lineages.

"Our findings provide evidence for an emerging view that somatic cells may be reprogrammed safely and simply by defined chemicals and other factors, which may facilitate their clinical use," said Ahmad. "The next step is to know how robust the reprogramming is and what existed within the microenvironment to cause it."

The team sampled progenitor eye cells, which regenerate the eye's cornea, from laboratory rats. By reprogramming them to resemble stem cells they acquired the properties necessary to replace or restore neurons, cardiomyocytes, and hepatocytes, cell types which are degenerated in Parkinson's disease, heart disease, and liver disease.

This reprogramming technique may allow 'autologous cell transplantation', where the donor of the cells is also the recipient. This is preferable to using cells from another person which may cause the patient's immune system to reject the transplanted cells.

Also, because this technique involves the use of iPSCs derived from adult eye cells and not embryonic stem cells (ES) it side steps many of the ethical dilemmas which have embroiled stem cell research.

"This research shows that it is possible to take cells from a patient's eye without affecting vision and reprogram them for use in autologous cell therapy to replace or rescue degenerating cells," concluded Ahmad, "this would allow us to circumvent ethical issues and the problems caused by the immune system rejecting foreign cells."

Retinal cells from iPS cells… no need for embryos

2009-08-26T18:07:00.001+10:00

Remember the excitement about ESC being used to create retinal cells? Big headlines amongst the excitable. Now, of course, the Aug. 24 edition of the Proceedings of the (US) National Academy of Sciences shows the creation of human retinal cells from the superior-in-every-way iPS cell derived from skin.

Says the University of Wisconsin-Madison School of Medicine scientist: "This is an important step forward for us, as it not only confirms that multiple retinal cells can be derived from human iPS cells using the Wisconsin approach, but also shows how similar the process is to normal human retinal development."

Here is the report in Science Daily: http://www.sciencedaily.com/releases/2009/08/090824151258.htm

Retina Cells Created From Skin-derived Stem Cells

Excerpts:

"The Wisconsin team took cells from skin, turned them back into cells resembling embryonic stem cells, then triggered the development of retinal cell types.

"Because the group was successful using the iPS cells, they expect this advance to lead to studying retinal development in detail and treating conditions that are genetically linked. For example, skin from a patient with retinitis pigmentosa could be reprogrammed into iPS cells, then retina cells, which would allow researchers to screen large numbers of potential drugs for treating or curing the condition.

"The team had similar success in creating the multiple specialized types of retina cells from embryonic stem cells, underscoring the similarities between ES and iPS cells."

'Similarities' indeed between ES and iPS cells – they are functionally identical - but there are vital dissimilarities in the relative usefulness of iPS and ESC:

only iPS matches the patient, so only iPS is useful for genetic research and drug tailoring for that patient;
only iPS could (if any pluripotent cell is ever considered safe) be used in transplants of retinal cells without the need for immune suppression.
only the ugly science of ESC research involves strip-mining an embryonic human for its useful bits.

And as per our earlier Blog on the Big Deal about ESCs producing retinal cells:

For that matter, why use either ESC or iPS when you can use adult stem cells (ASC)? We already have reports of the capacity of ASCs to generate the same retinal cells generated by ESCs in this 'breaking news'. Again, there is not one but TWO huge clinical differences. ASCs, like iPS cells, match the patient – but ESCs are foreign. Further, ASCs alone are free from the tumour risk inherent in ESC / iPS cells. Which type of cell would you, the patient, prefer to have in the back of your eye?

This is the whole point: iPS cells shed light on a rare disease

2009-08-21T15:51:00.001+10:00

Here is how it works, if you want to get specific cells from a patient to study their rare disease and test treatments on those cells. In this case, brain cells – without biopsying a bit of brain – in patients with FD (familial dysautonomia). And don't' forget, that is really the one serious use of iPS or ESC: researching a genetic disease and developing treatments. Talk of so-called direct cell therapies with ESC or iPS cells is just tall tales for journalists to help them sell papers; as we know, only adult stem cells are safe for use in direct cell therapy.

Meantime, back at the lab, Susan Slaugenhaupt, a neurologist at Massachusetts General Hospital, says this technology provides "the ability to examine disease-relevant cell types from patients" for the first time. "You can't get brains from patients and look at these cell types." They even find a promising response in vitro to one of their drugs.

And as the research article in Nature says today: "Our study illustrates the promise of iPSC technology for gaining new insights into human disease pathogenesis and treatment."

And that is the whole point. No ESC has ever given insight into a particular patient's disease, because you would have to clone that patient into his twin embryo first to get its stem cells (which has never been achieved). Why bother, when iPSC is doing the job?

Read today's MIT report at http://www.technologyreview.com/biomedicine/23288/

Or look up the Nature article at doi:10.1038/nature08320

ESCs – again a redundant dud

2009-07-29T13:35:00.004+10:00

Look at this pitifully muddled headline from the US News & World Report earlier this month:

Embryonic Stem Cells—and Other Stem Cells—Promise to Advance Treatments

Adult stem cells may reach patients first, and induced pluripotent stem cells have greatest potential

Do you spot the incoherence? That media tart, the embryonic stem cell, gets star billing in the main headline – but in the subheading and in the substance of the article, is shown (again) to be redundant.

How long will it be before there is some straight talk by scientists and journalists?

Yes indeed, adult stem cells 'may' reach patients first (correction: 'have reached' thousands of patients already, including over 2000 patients with heart disease alone) because only ASCs can be used in humans safely (i.e. they don't form tumours and don't require immune suppressive drugs). And yes indeed, iPS cells 'have greatest potential' (since in every possible measure of potential, iPS match or exceed the usefulness of ESC – again, because they are simpler to make, ethically innocent, and exactly match the patient to be studied).

Why then keep the artificial life-support on ESCs in every headline, every article ('ESCs are still the gold-standard' and other nonsense) when iPS has left it for dead? Just look at the clear statement of the superiority of iPS in this article:

"And because the (embryonic) cells are biologically foreign—like a transplanted organ—recipients will need to take powerful immunity-suppressing drugs, which have a host of side effects, to prevent rejection. It's that latter problem that makes scientists particularly excited about iPS cells, which would have the clinical potential of embryonic cells but can be created from a patient's own cells. Reprogramming an adult cell into an embryo-like, more malleable state sidesteps the issue of immune rejection, not to mention the moral debate."

And because both of these pluripotent cells naturally cause tumours, they are both inferior to ASCs for actual trials in human patients.

Ill-informed ESC puffing remains a trial of human patience, nothing more.

iPS repairs heart damage in mice

2009-07-21T09:45:00.004+10:00

Even the opening paragraph of this paper from the Mayo Clinic is pure music...

"R egenerative medicine offers the potential of curative therapy to repair damaged tissues.
Pluripotent stemcells derived from the inner cell mass of early-stage embryos have provided a prototype for multilineage repair. Ethical considerations along with practical limitations, however, have precluded adoption of embryonic stem cell platforms, driving advances in nuclear reprogramming to establish viable alternatives.
In this regard, induced pluripotent stem cell (iPS) technology provides an emerging innovation that promises the unlimited potential of embryonic stem cells while circumventing the need for embryonic sources".

A very cute bit of research - although I always seem to be a party-pooper, reminding excited people that while iPS is useful for genetic research and drug testing, it is no more feasible for direct implantation into humans than are ESC, as both are pluripotent and therefore tumorigenic; only the lowly ASC can be safely used (and has been used now in over 2,000 humans with heart disease... eg at John Hunter in Newcastle, Victor Chang in Sydney...never mind little white mice).

Always, however, the point is this: that if ESCs are useful for anything at all, iPS have the identical, exact same usefulness - and more, because iPS is a genetic match to the patient, while ESC is not.

But readers of this Blog understand that...

Here is the Reuters report on the paper:

Embryonic-like cells repair damaged mouse hearts Mon Jul 20, 2009

CHICAGO (Reuters) - Ordinary cells reprogrammed to act like embryonic stem cells can help repair damaged heart tissue in mice, researchers reported on Monday in a study that shows a potential practical use for the experimental cells.

When injected into mice whose hearts had been damaged by a heart attack, the new cells helped improve both the structure and function of the heart. Eventually the hope would be to patch up seriously ill heart patients using their own cells.

"It was obvious to the observer which animals had been treated and which ones hadn't," said Dr Timothy Nelson of the Mayo Clinic in Rochester, Minnesota, whose study appears in the journal Circulation.

The team used a promising new type of embryonic-like stem cell called an induced pluripotent stem cell, or iPS cell, made from ordinary cells. Many teams are using this new technology to look for ways to repair the body, a fast-growing field of research known as regenerative medicine.

Like embryonic stem cells, induced pluripotent stem cells have the ability to form any kind of cell in the body. Because they come from adult tissue, their use is less controversial than embryonic stem cells, which come from days-old embryos.

etc etc… Read the full report at http://www.reuters.com/article/scienceNews/idUSTRE56J51M20090720

Industry loves it: iPS from a simple blood sample

2009-07-10T13:26:00.002+10:00

Look at this new bit of good news where James Thomson’s company makes iPS from human blood – so any old blood sample can now become that ‘liquid gold’ that the cloning fantasists once claimed was to be found on their dig alone. Look at this summary comment about these iPS cells being just exactly the same as ESC, thank you vey much…

“Analysis revealed that the iPS cells are functionally identical to embryonic stem cells and iPS cells generated from other human tissue sources, that they carry the same genetic background as the source blood sample, and that they have the pluripotent ability to differentiate into any cell type.”

Cloning embryos has never achieved even a single patient-specific pluripotent stem cell, while iPS is achieving that goal with embarrassing ease.

What justification is left, then, for even attempting to clone human embryos – when the longed-for genetically-matched stem cells can be obtained so simply and ethically?

iPS is meeting all the goals of science and industry:

"Industry's challenge was to reliably create iPS cells from a commonly available and easily accessible tissue source and we focused on stored human peripheral blood samples," said Chris Kendrick-Parker, chief commercial officer of CDI. "Generating pluripotent stem cells from small volumes of blood, either freshly collected from a patient or accessed from blood storage repositories, provides a convenient source for generating patient-specific stem cells that are valuable research tools and may one day be used as a cellular therapy to treat disease."

Have no doubt: industry is going to drive the ethical alternative of iPS because it is a winner. SCNT cloning is a failed fantasy, a diseased fruit blighting the vine of stem cell science.

Media Release: ‘Sperm from Embryonic Stem Cells’ – a wanton abuse of embryos

2009-07-08T17:11:00.001+10:00

FOR IMMEDIATE RELEASE –

"The abuse of embryonic humans reached a sinister new low today with the announcement that scientists in Newcastle, UK, have derived functional sperm from embryonic stem cells" said Dr David van Gend, national director of Australians for Ethical Stem Cell Research.

"This is an abuse both because of its implications – namely, that scientists can now exploit a dead embryo as a source of sperm – but also because it was entirely unnecessary to use embryos as the source of stem cells. That was an ethically wanton act, to use embryos when an uncontentious and superior alternative was available.

"If there is any medical value in learning to create sperm from stem cells – and there are some arguable uses – then this objective could have been met in an ethically uncontentious way: the sperm could equally well be created from non-embryonic stem cells. Indeed the Newcastle researchers are already working on creating sperm from iPS cells, without exploiting embryos: Time magazine reports that "Nayernia's group is now working on creating sperm from the skin cells of infertile men (the sperm cells in the current study were generated from embryos discarded by fertility clinics)"

"We know that iPS cells, derived from adult cells without ever using eggs or embryos, are the exact functional equivalent of ESCs. Anything an ESC can do, an iPS can do – with the further advantage that iPS exactly matches the patient. The sperm created from embryos are that embryo's sperm. The sperm created from an iPS cell are the sperm of the adult whose skin cell was transformed into an iPS cell, and then into sperm.

"One valid medical application of sperm-from-stem-cells would be to enable infertile men – perhaps victims of mumps in childhood, or cancer treatment as young adults – to regenerate their own sperm from their own iPS cells. When this is done with iPS cells from the man himself, that avoids the exploitation of an embryo, and keeps the relationship of father-mother-child intact, since the sperm cells would indeed be derived to the patient himself.

"Incredibly, the Newcastle scientists suggest that SCNT cloning is the way to go to achieve genetically-matched stem-cell-sperm for an infertile man.

"But it would be scientific (and financial) folly to attempt to clone a patient into his twin embryo, in order to extract its stem cells – a task that has never been achieved - and turn them into sperm cells, when one could simply scrape his skin and turn those cells directly into pluripotent iPS cells – a task that is routinely achieved - and thereby into genetically-matched sperm.

"The abuses of embryonic stem cell science must be ended now that we have, in iPS, a scientifically and ethically superior alternative. I look forward to the Newcastle group's paper showing the creation of sperm from iPS cells, not embryos", Dr van Gend concluded. ENDS.

Watch this show! ABC TV ‘gets it’ re the iPS revolution

2009-06-26T18:50:00.006+10:00

http://www.abc.net.au/catalyst/stories/2608076.htm

Last night we saw that rarest thing: a nearly-accurate presentation of stem cell science on television. At last, the popular programmes – from Oprah in the US, to this more serious show, Catalyst, in Australia – are getting the message right (and maybe without even reading this Blog…):

"You are about to witness what the Science journal described as 'breakthrough of the year'. Where stem cells are created from ordinary adult cells, without the use of eggs or embryos."

There is first a detour through the history of ESCs – where they politely avoid the issue of tumour formation, but do refer to the immune-rejection problem - and then a reference to ASCs – where the weary old fallacy shows up (that lacking pluripotency is a disadvantage of ASC – whereas, as we know, it is a curse to be pluripotent: it makes you a dangerous, tumour-forming nuisance). These supposedly less useful 'multipotent' ASCs are shown, in another segment of the show, being use as therapy for damaged cartilage – in both a horse and a patient. No tumours there! All good. See http://www.abc.net.au/catalyst/stories/2608197.htm Noticeable by their absence from any actual therapies are those little ESCs which are supposedly so much more 'potent'… Hey ho…

Next, the story returns to the Gee-Wizz headline about the iPS revolution:

"And in 2008, scientists did that successfully with human cells. They're called Induced Pluripotent Stem Cells, or iPS cells. Now in theory, any cell in our body can become like an embryonic stem cell. … Researchers are still figuring out how this amazing transformation takes place. Put simply you start with an adult cell, say a skin cell. You then insert four genes into the cell, the kind of genes responsible for regulating the cells development. And that effectively reprograms the cell, wipes the slate clean and sends it back to the embryonic state. You can then direct it to become any cell you like, say a heart cell."

Enter Prof Bob Williamson. This is the same scientist, spokesman for the AAS on cloning, who brought you the most offensive furphy in the early stages of the cloning debate – that cloning does not really create a human embryo (he called it an 'intermediate cellular product', as I recall). That argument was designed to remove the moral sting from cloning, since if it does not create a living human embryo, what is the big fuss? But eventually even Loane Skene of the Lockhart Committee admitted that – as with Dolly the sheep – SCNT cloning does indeed create a human embryo, which could, in theory, be born as a baby.

Interviewed for last night's show, the Professor appeared to be on song with the South Australian scientists who recently tried to denigrate iPS to MPs: try to smear iPS as being somehow uniquely 'dangerous', and therefore make the case (as in SA) that 'we still need to do cloning and ESC research…'

Here it is:

"But Bob Williamson urges we proceed with caution before injecting genetically modified IPS cells into people.
PROF. BOB WILLIAMSON:
"Obviously we have to know whether IPS cells can cause cancer or not and we don't even know that with certainty."

Cancer! Injecting cancer-causing cells into people! That gives iPS a real 'danger' label. Smart politics, but not a scientifically transparent statement of the equivalence, in terms of any 'dangers', of the new iPS and the old ESC. No, what a scientist in Prof Williamson's position might have explained to the viewer is this:

"Obviously we would never inject iPS cells into people any more than we would inject ESC into people. You can't do that, as they both form tumours. We can only inject ASCs into people. What we can do with ESC and iPS cells is study genetic disease and develop drugs against those diseases. And of course, dear viewer, any useful research an ESC could do an iPS can also do - because they are functionally identical cells. Indeed, the iPS is superior because it is an exact genetic match of the patient, while an ESC could only be a genetic match if one first clones the patient into an embryo, in order to destroy it for its stem cells… What sort of mug science is that, undertaking the ethically contentious, enormously expensive and technically difficult (indeed impossible, so far) act of SCNT cloning for stem cells, when you can so easily obtain the exact same research cells by scratching off a bit of skin?"

And then we have another worried comment from the Professor, this time on the troubling ethics (I jest not) of iPS: "the idea that every cell in your body has the potential to become an embryo, is itself a slightly scary thought". In the context of this TV story, his comment is another subliminal message of caution about these worrying little iPS cells - and it is a load of nonsense. There is only one cell in anyone's body that can 'become an embryo' and that is the oocyte. The woman's egg alone has the totipotency (that's one up on pluripotency) to 'become an embryo' once fertilised (or once tricked by cloning into 'thinking' it's been fertilised). Other cells can provide the nuclear DNA for SCNT cloning, and thereby act as a bogus 'sperm' - but they lack the cellular machinery for forming the whole show - placenta and embryo together. Prof Williamson is mistaken; no other cell in the body can ever develop into an embryo. Therefore his ethical suggestion that 'any cell' is now, since iPS, somehow morally equivalent to an embryo is misguided. It harkens back to his original attempt to degrade the true embryo created by cloning - to the status of an 'intermediate cellular product'; this time the moral equivalence smear is to upgrade 'any cell in our body' to the moral status of a potential embryo, and therefore remove the 'specialness' of the embryo.

Very disappointing spin coming from an honest scientist.

We can look forward to plenty more muddying of the waters by embryo-research advocates as we head into the cloning review next year. Yet shows like the ABC Catalyst of 25^th June 2009 show that the truth of the redundancy of embryo experimentation is going to be harder to obscure behind scientific smokescreens.

Dr Margaret Somerville: why embryo experimentation is wrong – and unnecessary

2009-06-26T18:01:00.001+10:00

Another pithy summary of the arguments for and against ESC research – from a professional ethicist (of Australian origin).

Well worth a read for those who want to think like an adult, not like a sound-bite-juvenile.

First, why embryo experimentation is wrong:

"We are all ex-embryos and are all in the process of becoming, from conception to death… Human embryo stem cell research kills embryos and destroys that potential. The central ethical issue it raises is: What does the value of respect for human life require that we not do to human embryos?"

And later, why embryo experimentation is redundant:

"As mentioned already, there are now ethically uncontroversial alternatives for obtaining pluripotent stem cells -- iPS technology. This is an example of science being able to solve ethical problems rather than creating them… Stem cells can also be obtained from umbilical cord blood or consenting adults. So far somewhere around 200 therapies have been developed from these ethically uncontroversial alternatives, while none have yet come from embryo stem cells."

But that snapshot does no justice to such an elegant, if brief, review of the subject. For the full article, pick up a copy of the Ottawa Citizen from the 22^nd June – or click here: http://www.ottawacitizen.com/Technology/Destroying+life+science/1719495/story.html

Caplan Capitulates on Cloning…

2009-06-20T13:11:00.004+10:00

Hidden here in the Scientist Blog from Thursday 17^th is another 'moment of truth' – this time from the noted bioethicist and not-usual-suspect, Arthur Caplan: "the odds are that cloning for research is never going to work".

Sweet on the ear. And scientifically correct. Cloning has been dead in the water at least since November 2007, despite the millions of dollars expended since then, and the dozens of desecrated human offspring. Nobody has managed to get a cloned human embryo to live long enough to form its inner cell mass of stem cells – those magic 'patient-matched' pluripotent stem cells that justified cloning in the first place. Meantime, the exact same patient-matched pluripotent stem cells have now been produced easily, cheaply, and surely by iPS direct reprogramming. Already we have hundreds of such stem cell lines up and running. Cloning, ladies and gents, is withering on the vine and will soon become mere pseudo-scientific compost…

Yet still the embryo lobby acts as if drunk on this rotting fruit, lurching around, refusing to admit that there is a better, less contentious science at hand.

Sadly, the mere ethical objection against creating living human embryos for the sole purpose of destroying them will never cause them to sober up. The only motives for them to kick their cloning habit will be the gangbuster success of the alternative, iPS, and the prospect of litigation from women injured in obtaining the necessary thousands of eggs for these experiments.

This prospect of obtaining more eggs from women is the subject of debate in this Scientist blog. New York State has now broken another rule of ethical research by proposing to buy eggs from (predictably poor) women – a decision reached following, of course, 'extensive deliberation' from its obliging ethics team.

Two issues: the possible exploitation of the poor by making women's ovaries a tradable commodity:

Many critics, including Father Thomas Berg, director of the Catholic think tank Westchester Institute for Ethics & the Human Person, argue that compensation will lead to the exploitation of poor and disenfranchised women. Paying women as much as $10,000 -- the upper limit under the ESSCB's directives -- will "create an undue inducement" that will put vulnerable women at risk, he said. "It's precedent setting."

Second issue, whether obtaining eggs for SCNT cloning is even justified scientifically. Enter Caplan:

"I don't think it's a good idea," Arthur Caplan, a bioethicist at the University of Pennsylvania, told The Scientist.

It's "more ethically acceptable" to pay women to harvest eggs for in vitro fertilization programs because donor eggs have proven successful in assisted fertility treatments. With stem cell research, "the risk benefit ratio starts to slide," Caplan said. "It's a lot iffier a proposition and I think that makes a difference. In research you don't know what you're going to get, and the odds are that cloning for research is never going to work."

Of course, others continue to urge the need for women's eggs. The bioethicist for Advanced Cell Technology (ACT), a keen cloning company, speaks for the affirmative:

Ronald M. Green, a bioethicist at Dartmouth College in New Hampshire, said he's "glad to see" the ESSCB's decision. Green, who serves pro bono on the ethics advisory board of Advanced Cell Technology, a Massachusetts-based biotech company, said that it's ethical and necessary to pay women to donate eggs for stem cell research if researchers want to investigate the potential of therapeutic cloning.

ACT is especially clear on the need for human eggs, given their recent publication showing that the animal option – rabbit or pig eggs, for instance – is an utter failure. See the Blog on 'More nails in cloning's coffin: Frankenbunny RIP'.

Here, then, is the story on the latest desperate move by 'progressives' to shore up the crumbling edifice of SCNT cloning. Too late, and not worth the trouble, I am glad to say…

http://www.the-scientist.com/blog/display/55766/

The Scientist: NewsBlog: NY to pay for eggs for research - 17th June 2009

Smart private money backs adult stem cells

2009-06-19T09:08:00.006+10:00

From this week's FORTUNE magazine, the rich people's rag, another greenshoot of commonsense on stem cell science.

We have already have seen that notably rich man, Al Gore, invest many of his own millions in iPS. And we heard some sound advice to Mum and Dad investors on the Oprah episode where that notable salesman for embryo experimentation, Michael J Fox, had his portfolio priorities trashed by Dr Oz.

Now another confirmation that smart money, if not serious ethics, will be the one to give the thumbs down to embryonic 'therapies' and get on with the serious business of using iPS and ASCs. Only dumb public money (as per Obama) will continue to be squandered on desecrating embryos.

Note the standard journalistic trope about embryo cells being possibly more useful for treatments in the long-term... that is a mindless mantra which readers of this Blog could demolish in a few short sharp blows:

1. You can never use ESCs as treatment, since they form tumours (unlike safe ASCs);

2. If you only want to derive secondary cells as 'treatment' (as per Geron Corp) then you would always do better to use iPS cells as the 'factory cells', as they are genetic matches - whereas ESCs are not;

3. smart money says the default position is always to use cheap and simple iPS cells, as they are easy to obtain, superior as research material, and ethically non-contentious...

No, the journos will someday realise how vacuous their comments are about ESCs, which remain inferior in every way to iPS - let alone to ASC.

Adult stem cells are a promising market
Amid controversies over embryonic stem cell research, drugs using adult
cells are already bearing fruit.

By Anna Kattan, contributor
Last Updated: June 16, 2009: 11:03 AM ET
http://money.cnn.com/2009/06/16/technology/adult_stem_cell_therapy.fortune/index.htm

NEW YORK (Fortune) -- When it comes to stem cells, the public -- and the
media -- tend to focus on embryos. But researchers and analysts say
marketable therapies already are emerging from less controversial work
with adult stem cells.

Adult cells make up the lion's share of the stem cell space, mainly
because they are easier to come by than embryonic cells, and less expensive to
run in clinical trials. They are also derived from mature tissue, like bone
marrow or umbilical cord blood, so they avoid the ethical debate that
surrounds embryonic stem cells.

To be sure, many researchers consider embryonic stem cells to be more
versatile, and they may someday be more useful than adult stem cells in
treating diseases. But researchers also hope adult stem cells can help
them combat a variety of maladies from diabetes to heart disease.

In fact, adult stem cells are currently the only type of stem cells used
in transplants to treat diseases, such as cancers like leukemia.

Furthermore, researchers are far closer to commercializing drugs based
on adult stem cells than any product based on embryonic stem cells.

Read the full article…

Adult stem cells repair corneal blindness

2009-06-02T12:53:00.001+10:00

Here is a tidy NSW application of our ever-versatile adult stem cells.

Corneal regeneration in humans has been around for some years using adult stem cells, but here a simple contact lens is used as the vehicle for applying the stem cells to the damaged surface.

Safe, cheap, and obviously "non-controversial", as Loane Skene (of the Lockhart Committee on human cloning and embryo research) points out.

To use cloning or embryos to obtain stem cells would not only be controversial, it would be plain stupid – as the cells are so second-rate: lacking the perfect immune match of our own stem cells, and likely to provoke tumours (and of course the exact same concern of tumours applies even to iPS cells).

Behold the future (and the present) of safe and effective stem-cell therapy: our own, simple, non-controversial cells.

Full story at: http://www.news.com.au/story/0,27574,25549740-36398,00.html

Excerpts:

COATING a common contact lens with stem cells could help restore a person's sight, Australian scientists have found.

University of New South Wales medical researchers used the technique to treat the damaged corneas of three patients, all of whose vision improved within weeks of the groundbreaking procedure. The results are published in the journal Transplant.

Stem cells were harvested from the eyes of each patient and then cultured inside a contact lens, which was then stuck onto a damaged cornea in a "transplant'' of regenerative cells.

"The procedure is totally simple and cheap,'' said the university's Dr Nick Di Girolamo. The procedure could be replicated in third would countries by a surgeon with a laboratory for cell culture, Dr Di Girolamo said.

It offered hope to people with a range of blinding eye conditions, he said, and there was also the possibility of adapting the technique to repair skin which behaved in a similar way to the eye.

The stem cell procedure was considered non-controversial, said former Deputy Chair of the Lockhart Committee on human cloning and embryo research Professor Loane Skene.

Read this! Wilmut, King of Cloning, says iPS has made cloning ‘no longer applicable’

2009-05-20T09:37:00.001+10:00

A remarkable interview this month with Prof Ian Wilmut – who created the first cloned mammal in 1997, Dolly the sheep. Wilmut was the first senior scientist to signal the move away from cloning to 'induced pluripotent stem cells' (iPS cells) in November 2007 – see the report in the Telegraph, "Dolly Creator Ian Wilmut shuns cloning". This new interview shows again that the true shape of stem cell science is now acknowledged even by former advocates of cloning - and cannot be suppressed in the way it was during recent Parliamentary debates.

Browse the comments by Wilmut, and note that they exactly match what honest scientists – including this association – have been trying to get through to journalists and MPs since the iPS cell revolution of November 2007 – namely that the one justification that carried the vote for cloning is now dead and gone, and there is no longer any defence for this inhuman science:

iPS cells have achieved the exact goal that cloning hoped to achieve (but never has achieved) – namely, patient-matched pluripotent stem cells:
- "Before the discovery of iPS cells, we were trying to derive embryo stem cells produced by nuclear transfer from the cell of a patient who suffered an inherited disease. So far, nobody has been successful. But then, reprogramming somatic cells from mice (Yamanaka's method) demonstrated that the same objective could be achieved directly using somatic cells from patients."
iPS is up and running now, already being used in research, whereas EScell research from cloning has never even started – and now has lost its justification:
- "People do not yet realize that studying inherited diseases on cells obtained by reprogramming is much easier and faster than getting human embryonic stem cells by cloning. The iPS technique to obtain stem cells is now the most efficient technique for researchers, in particular for research on inherited diseases."
Contrary to the claims of the embryo-research lobby, we never really needed to experiment on human embryos to obtain this new, ethical stem cell science of iPS; Yamanaka has never touched a human egg or human embryo:
- "The de-differentiation of somatic cells didn't require the use of human embryos as, technically speaking, it wasn't necessary. The first iPS cells were produced and identified through studies on mouse embryos."

The French interview is at http://www.genethique.org/tribunes_mensuelles/mai_2009.asp

For the sake of non-French readers, here is the full English translation:

Gènéthique Interview with Prof. Ian WILMUT, May 2009:
Chair of Reproductive Biology at the Medical Research Council Centre for Regenerative Medicine in Edinburgh, Ian Wilmut was the first to succeed in cloning a mammal in 1997 – Dolly the sheep.

Is research on the embryo and cloning still necessary
since the discovery of iPS cells ?

1 - After the discovery by Prof S. Yamanaka and J. Thomson in November 2007 , you told the BBC that you gave up cloning in favour of iPS cells and that "within five years the new technique could provide a better and ethically more acceptable alternative to cloning embryos for medical research". Since 2007, what have been the advances in research with iPS cells, compared to the scientific expectations and goals you had in cloning Dolly ?

WILMUT: "Before the discovery of iPS cells, we were trying to derive embryo stem cells produced by nuclear transfer from the cell of a patient who suffered an inherited disease. So far, nobody has been successful. But then, reprogramming somatic cells from mice (Yamanaka's method) demonstrated that the same objective could be achieved directly using somatic cells from patients.

"The main therapeutic advantage with iPS cells is that they are genetically identical to the patient, they can be used for disease modelling and to look for drugs to prevent symptoms of the disease. There are already about a hundred cell lines on which it is possible to work right away, and which could help us to understand diseases within 5 years.

"Therefore, the technique of cloning is no longer applicable. As with my experiments with Dolly the sheep, cloning requires considerable time to obtain stem cells. Moreover, this technique asks women to undergo ovarian hyperstimulation: they will have to endure an intensive and unpleasant hormonal treatment in order to produce a high number of oocytes and still obtain only a low number of cloned embryos.

"If science can offer faster, more interesting and more efficient means, I want to use them.

2 - What are the scientific and therapeutic hopes with iPS cells? And what are the challenges for researchers ?

WILMUT: "Researchers working on iPS cells are trying to improve the quality of these cells. Their availability and capacities are unquestionable, but the technical challenge is to successfully reprogram cells without provoking collateral damage. It will take very little time to overcome these obstacles: recent scientific publications showed that it is already possible to reprogram differentiated cells using neither viral vectors nor plasmids.

"For economic reasons, I think it no longer possible to envisage creating personal stocks of iPS cells for each patient to look for treatments to their diseases. What would be more feasible from my point of view is to have a sort of registry, or Bio-Bank, where cell lines for different kind of immunological diseases would be listed. It would then be possible to modify and work on these cell lines according to the requirements of each patient.

3 - In France, it has been said that iPS cells were obtained thanks to human embryonic stem cells. However, Prof. Yamanaka's publications on human iPS cells were preceded by results on mouse cells . Could iPS cells have been discovered solely through research on animal models, without recourse to human embryonic stem cells?

WILMUT: "The de-differentiation of somatic cells didn't require the use of human embryos as, technically speaking, it wasn't necessary. The first iPS cells were produced and identified through studies on mouse embryos.

"People do not yet realize that studying inherited diseases on cells obtained by reprogramming is much easier and faster than getting human embryonic stem cells by cloning. The iPS technique to obtain stem cells is now the most efficient technique for researchers, in particular for research on inherited diseases.

"There is also research being done on human embryonic stem cells to better understand their differentiation and cultivation, because iPS cells share the properties of human embryonic cell lines.

4 - Research on iPS cells is accelerating in the USA and in Asia. How about in Europe ? Is there significant support for this research ?

WILMUT: "Research on iPS cells is supported in many European countries: British agencies such as the Biotechnology and Biological Sciences Research Council (BBSRC) are financing programs at the University of Edinburgh where I am currently working. In France too, interesting projects are underway with iPS.

5 - Is there more scientific interest in using human iPS cells than human embryonic stem cells to look for drugs, for (disease) modelling and for screening of pharmacological molecules ?

WILMUT: "Yes. iPS cells are more useful than embryonic cells for this research because, if you take reprogrammed cells from a patient who has an inherited disease you want to study, the advantage is that these cells already carry the characteristics of that person. You do not have to introduce a genetic error. There are many inherited diseases for which we do not yet understand the molecular basis."

Science publishes warning against embryo stem cell hype

2009-05-11T18:08:00.001+10:00

Better late than never, a reality-check from a senior scientist who can see how embryonic-stem-cell hype serves no good end.

James Wilson has published "A History Lesson for Stem Cells" in the journal Science yesterday, drawing on his experience of the similar hype and hysteria that surrounded his field of gene therapy. His diagnosis is precise of the forces that distort the public perception of embryo research / cloning – and so derail the votes of our politicians.

For example... "A large and vocal population of patients suffering from a wide variety of ailments is pressing for stem cell-based therapies. Disease-specific stem cell research groups are more politically sophisticated than ever, in some cases employing congressional lobbyists. Unrealistic expectations have been fueled by relentless media coverage..."

That is exactly what we condemned on the header of our previous Blog, 'Conscience versus Con-Science': An effective strategy whereby scientists, via a gullible media, peddle false hope and disgraceful hype to desperate patients, who then beat down the door of MPs demanding liberal legislation on cloning.

After reading this article, I think anyone would have a more sober sense of the true shape of stem cell science, and the forces driving the hype and false claims about cloning and embryonic-stem-cell research.

(Remembering that the humble fellow-traveller, adult stem cells, have none of the problems of immune rejection or tumour formation identified in this article - they are safe and proven to be effective - but not as 'sexy' as messing with embryos, for some reason...)

Ah, yes, the truth will out, however belatedly! Unnecessary and unethical science will die by its own internal corruption; that is what this Blog will have the wry pleasure of documenting, re cloning and embryo experimentation, over coming years.

Excerpts from Science below:

A History Lesson for Stem Cells

James M. Wilson

University of Pennsylvania, Philadelphia, PA 19104, USA; Science 8 May 2009:Vol. 324. no. 5928, pp. 727 – 728 DOI: 10.1126/science.1174935

"...Unfortunately, some stakeholders in hESC research have failed to exhibit the same restraint, effectively promising cures for Parkinson's disease, Alzheimer's disease, spinal cord injuries, diabetes, cancer, heart disease, multiple sclerosis, muscular dystrophy, macular degeneration, and hearing loss, to name a few.

"...It is difficult to avoid getting caught up in the unabashed enthusiasm that attends the emergence of a novel, but untested, therapeutic technology platform, as I myself experienced. Still, January's media coverage of the first U.S. Food and Drug Administration (FDA) approval of a hESC-related clinical trial-an experiment sponsored by Geron Corporation of Menlo Park, California, aimed at spinal cord injuries-was surprising for its lack of restraint. News reports characterized Geron's mere gaining of federal permission to test the cells in patients as a "breakthrough" (10). And in a highly questionable move, Good Morning America accompanied its news report with faux video footage depicting the paralyzed actor Christopher Reeve getting out of his wheel chair and walking again (10).

"...Despite advances, our understanding of the biology of hESCs and iPS cells remains thin with regard to clinical safety and utility. Controlled incorporation of transplanted stem cells into host tissues and organs remains a major challenge. Questions about engraftment, rejection, and toxicity abound. Steps involved in transformation of hESCs, iPS cells, or their derivatives into tumor cells (and strategies to ablate any tumors that might arise) need further investigation. In February, researchers in Israel reported that a 13-year-old boy with ataxia telangiectasia who had received injections of human fetal neural stem cells into his brain as part of an experimental treatment performed in a Russian clinic developed brain tumors apparently derived from the injected stem cells (11).

"...I encourage hESC and iPS researchers to remember the Orkin-Motulsky report's central theme: that no one is served by bypassing the hard work of basic research and experiments in animal models."

See also his interview and comments this week in the rival journal, Nature, at: http://www.nature.com/news/2009/090507/full/news.2009.455.html

More for Scholars: hundreds of human iPS cell lines from at least 13 diseases to end April 2009...

2009-05-05T17:31:00.010+10:00

Here is a neat summary of the current 212 induced pluripotent stem cell lines derived from human patients - with at least 13 distinct diseases, including of course Parkinsons and diabetes. Total of 516 iPS lines underway. By contrast, of course, to exactly zero stem cell lines (in fact nary a stem cell) derived from that quaint and so pre-November-2007 science of SCNT cloning... see document at: http://docs.google.com/View?docID=dcpmpcfg_11c8qfk9cv&revision=_latest

For an update on all publications in iPS, both animal and human (with human highlighted) since Yamanaka first started the Revolution, see the document at: http://docs.google.com/View?docID=dcpmpcfg_9fwddzbcp&revision=_latest

More excitement over genetically ‘pure’ iPS cell technique

2009-04-24T13:10:00.001+10:00

Another fine piece of science – and a great read - released today US time, giving an even 'cleaner' method of obtaining perfectly-matched embryonic-type stem cells (iPS cells) without ever creating or destroying an embryo. Once again we see that the furphy used by lobbyist-scientists in South Australia to distort the cloning debate there - namely that iPS cells are dubious because of 'genetic manipulation / viral integration' - is shown to be spurious. iPS cells are genetically as pure and safe (or unsafe) as anything made from embryos, and have the overwhelming advantage of matching the actual patient.

Note the final paragraph of the report below, confirming yet again that iPS cells (from our own skin) are functionally indistinguishable from embryonic stem cells, yet have the major technical advantages of genetic/immune compatibility and lab simplicity (and no ethical stress).

Hence the obvious question: what justification remains for using embryos, and of course, what possible place for manufacturing embryos by cloning?

The relevant paragraph reads: "The scientists found that those reprogrammed embryonic-like cells (dubbed "protein-induced pluripotent stem cells" or "piPS cells") from fibroblasts behave indistinguishably from classic embryonic stem cells in their molecular and functional features, including differentiation into various cell types, such as beating cardiac muscle cells, neurons, and pancreatic cells."

Here is today's press statement of the iPS paper in Cell Stem Cell:

A major breakthrough in generating safer, therapeutic stem cells from adult cells: Scientists completely avoid problems of genetic manipulation by instead using chemical programming

Public release date: 23-Apr-2009 http://www.eurekalert.org/pub_releases/2009-04/sri-amb042209.php

"The new technique solves one of the most challenging safety hurdles associated with personalized stem cell-based medicine because for the first time it enables scientists to make stem cells in the laboratory from adult cells without genetically altering them. This discovery has the potential to spark the development of many new types of therapies for humans, for diseases that range from Type 1 diabetes to Parkinson's disease.

The study was published in an advance, online issue of the journal Cell Stem Cell on April 23, 2009.

"We are very excited about this breakthrough in generating embryonic-like cells from fibroblasts [cells that gives rise to connective tissue] without using any genetic material," says Scripps Research Associate Professor Sheng Ding, who led the research.

"Scientists have been dreaming about this for years."

Normally, cells develop from stem cells into a myriad of increasingly more specialized cell types during early development and throughout a lifetime. In humans and other mammals, these developmental events are irreversible. This means that when tissues are damaged or cells are lost, there is usually no source from which to replenish them. Having a source of the most primitive stem cells available would be useful in many medical situations because these cells are "pluripotent," having the ability to become any of the body's cell types-potentially providing doctors with the ability to repair damaged tissues throughout the body.

However bright this promise, the use of stem cells in medicine has faced many hurdles. One strategy has been to work towards a therapy where doctors could take a patient's own adult cells and "reprogram"

them into stem cells. This not only avoids potential ethical problems associated with the use of human embryonic stem cells, it also addresses concerns about compatibility and immune rejection that plague therapies such as organ transplantation.

A few years ago, a team of researchers in Japan made a breakthrough in this general approach by converting mouse skin cells into mouse stem cells. The Japanese team accomplished this remarkable transformation by inserting a set of four genes into these skin cells. While the study was a powerful proof-of-principle, the therapeutic potential of genetically reprogrammed cells is limited because of safety issues. One obvious problem is that the four required genes and their associated foreign DNA sequences permanently reside in the cells when transplanted. Moreover, the specific genes in question are problematic because, in living tissue, they are linked to the development of cancerous tumors.

Many scientists have been trying to find safer ways to generate stem cells from adult cells -- developing methods that require fewer genes, or techniques that can put genes in and then take them out. However, to date all of these have still harbored significant safety concerns due to the nature of the genetic manipulations. Ding and his team previously reported the discovery of drug-like small molecules to replace some of those genes, but have also hoped to go even further and find ways to reprogram adult cells into stem cells without using any genes or genetic manipulations at all.

The team of scientists accomplished this extraordinarily challenging feat by engineering and using recombinant proteins, that is proteins made from the recombination of fragments of DNA from different organisms. Many different recombinant proteins have been therapeutically and routinely used to treat human diseases. Instead of inserting the four genes into the cells they wanted to reprogram, the scientists added the purified engineered proteins and experimen ted with the chemically defined conditions without any genetic materials involved until they found the exact mix that allowed them to gradually reprogram the cells.

The scientists found that those reprogrammed embryonic-like cells (dubbed "protein-induced pluripotent stem cells" or "piPS cells") from fibroblasts behave indistinguishably from classic embryonic stem cells in their molecular and functional features, including differentiation into various cell types, such as beating cardiac muscle cells, neurons, and pancreatic cells." ENDS.

11 reasons why we no longer need Embryos for Stem Cell Science – neurobiology Prof

2009-04-22T13:38:00.002+10:00

Excellent, brief, argument by a leading neuroscientist, as to why embryos (let alone cloned embryos) are no longer required for Stem Cell Science:

Link: http://www.stemcellresearch.org/commentary/answeringcommonclaims.htm

Does Research Really Need Human Embryos and Cloning?

by Dr. Maureen L. Condic

April 16^th 2009.

Neurobiologist Maureen L. Condic investigates 11 common arguments in favor of embryonic stem-cell research, and explains why science may not need the controversial technique, after all.

ESCs, iPS or ASCs for macular degeneration: a no-brainer.

2009-04-21T18:48:00.001+10:00

Yes, you read it in The Australian, that "an (embryonic) stem cell therapy to cure the most common cause of blindness has been developed. Surgeons predict it will become a routine one-hour procedure that will be generally available within seven years."

To the experienced eye, this is clearly another calculated bubble of hype – but for sake of argument, let's pretend this speculation actually might come to pass 'within seven years'. Then, in order to gently deflate this – or any – ESC bubble, let us ask the two key questions that any reasonable person must always ask:

Why use embryonic stem cells (ESC) when you can use induced pluripotent stem cells (iPS)? We know the two types are indentical in their properties, but there is one huge clinical difference: iPS cells match the patient, and ESCs do not. ESCs are foreign cells from a foreign individual, and require immune suppressants even in animal studies, to prevent rejection – just like with an organ transplant. Which would you, the patient, prefer?
For that matter, why use either ESC or iPS when you can use adult stem cells (ASC)? We already have reports of the capacity of ASCs to generate the same retinal cells generated by ESCs in this 'breaking news'. Again, there is not one but TWO huge clinical differences. ASCs, like iPS cells, match the patient – but ESCs are foreign. Further, ASCs alone are free from the tumour risk inherent in ESC / iPS cells. Which type of cell would you, the patient, prefer to have in the back of your eye?

In one example of ASCs used to generate retinal photorececeptor cells – published in the journal Stem Cells last year – the principal researcher comments on both the immune-rejection and ethical advantages:

Dr. Ahmad's research team recently published its findings in the journal Stem Cells. Their findings demonstrated that corneal stem cells could be converted into photoreceptors, he said, which suggests that they also could be used for repairing retinal damage. "This gives us hope that we may be able to manipulate these cells to treat retinal degeneration and restore sight," he said. "By using a person's own Muller adult stem cells, problems associated with immune rejection as well as the controversy surrounding the use of embryonic stem cells would be eliminated."

No, even if reckless authorities in the UK were to approve this proposed ESC trial, and risk tumours and immune rejection in the delicate ocular tissues of volunteers, sensible 'customer demand' will have the final say. No reasonable person will prefer ESCs – with all their ethical ugliness and need for innume suppressant drugs – over the simple and clean technique of iPS. Further, this reasonable person would not let either ESCs or iPS cells within a metre of my retina, when I could use ASCs instead and have no concern over tumours.

And finally, only ASCs are on track to treat the other aspect of macular degeneration – abnormal blood vessels in the retina.

For example, see Nature journal in 2002 – reviewed here. The researchers comment:

"Abnormal angiogenesis is the cause of visual loss in age-related macular degeneration, where new blood vessels grow under the retina.In the ocular disease models, the (adult) stem cells differentiated into endothelial cells and proliferated, forming new blood vessels. This actually rescued and stabilized the retinal vessels when they would otherwise be degenerated."

Or peruse the full article in the Journal of Clinical Investigation, 2004:

"In this study we demonstrate that whenever a fraction of mouse or human adult bone marrow–derived stem cells rescues retinal blood vessels that would ordinarily completely degenerate, a dramatic neurotrophic rescue effect is also observed."

Memo: whenever a claim for ESC therapy is made, always ask the two question: Why not use iPS and get a perfect genetic match? Why not use ASC and avoid the tumour question?

Never forgetting the one question that overarches this whole debate: Why not get this good science in an ethically uncontentious way, using a method that dose not exploit human embryos?

First Oprah, now Al Gore… realism is breaking out all over

2009-04-19T12:26:00.001+10:00

It has long been clear that smart private money is fleeing cloning and embryo experimentation in favour of iPS, while only dumb public money - as promised by Obama - will prop up that redundant science. In order, it seems, to prop up the cultural triumph over Bush and his obscurantist ilk.

Forgetting the inconvenient truth that it was Bush whose ethically-targeted funding made this magnificent iPS discovery possible, Al Gore, of hanging chad and Supreme court appeal fame, is now standing to profit from Bush's smart move. And all the best to him. But there has been no more satisfying demonstration of the true future of stem cell science than this week's announcement that the former vice-President is putting $20 million into the "hot area of 'induced pluripotent' stem cells."

"I think", says Gore, "this is one of those good news stories that comes along every once in a while… It's a very important breakthrough that is filled with promise and hope."

Journalists are intelligently stating the ethical, as well as scientific, advantage of iPS: "Human embryonic stem cells are controversial because their creation requires the destruction of early-stage embryos. Induced cells do not."

Interestingly, cloning of embryos to get matched stem cells is rarely getting a mention in reports on stem cell science these days; again, smart money can see no justification in pursuing the never-achieved and expensive goal of cloning yourself into a twin embryo in order to extract (still-imperfectly-matched) ES cells, when any corner lab can get the exact same (and perfectly matched) cells from a speck of your skin.

In this report, Robert Lanza is quoted as having 'cloned embryonic stem cells'. He did not. Nobody has got a cloned embryo to that advanced stage yet. Not a single ES cell from all of cloning's millions of dollars and incalculable abuses of human life. By contrast, iPS is "one of those good news stories" both scientifically and socially – and Lanza wryly remarks: "It's great that Al Gore supports iPS reseach, but who doesn't? Even the pope and the Catholic Church are on board." Apparently that odious company is not enough to deter fellow traveller Gore, and AESCR is very glad to have him – and Oprah – and all reasonable people – on board.

Article at http://www.usatoday.com/tech/science/ethics/2009-04-14-gore-stem-cells_N.htm

Oprah's moment of truth: "the stem cell debate is dead" thanks to iPS...

2009-04-14T13:57:00.003+10:00

Ladies and Gentlemen, you have to take a look at this ‘teachable moment’ on that leading scientific peer-reviewed programme, Oprah. See http://www.oprah.com/media/20090319-tows-dr-oz-brain

What a sight: Michael J Fox there suffering Parkinson’s (he is the number one ill-informed agitator for ESC research) being told by Oprah’s resident medical expert, Dr Oz, that “the stem cell debate is dead” because we can now “take a little bit of your skin” (here he touches Fox’s arm) and take it back to the same as embryo stem cells… Here is what was said, starting at about 2min 04 into the interview:

“I think, Oprah, the stem cell debate is dead, and I’ll tell you why… The problem with embryonic stem cells is that they come from embryos, like all of us were made from embryos, and those cells can become any cell in the body, but it’s very hard to control and they can become cancer”… (this is at 2min35, and MJ Fox looks a little more restless at this point, and Oprah is tight-lipped, sensing a ‘non-PC moment’). “But in this time of fighting that we’ve had – which did I think slow down research – there have been a huge amount of changes. In the last year we’ve made 10 years’ advancement… and here’s what the deal is: I can take a little bit of your skin, take those cells, and get them to go back in time so they’re like they were when you were first made. And then they will start to make that dopamine.

“And I think that those cells – because they won’t be as prone to cancer because they’re your genes – will be the ones that will ultimately be used to cure Parkinson’s. And nobody can tell how fast we can do this, but I’ve talked to a lot of experts in this field, but I think we’re single-digit years away from making a big impact on the lives of Parkinson’s disease, but not only Parkinson’s diseases, also diabetics, heart attack victims, people who had a lot of problems…”

Remarkable that this word of truth – which validates President Bush’s policy of funding the search for ethical alternatives to embryos research - should ever be heard on the Oprah (Obama’s #1fan) show. I can think of one constructive explanation: the departure of Pres Bush means there is no longer a visceral need for the Oprah-liberal camp to promote ESC / cloning just as part of a culture war against Bush; they are free to be more even-handed about stem-cell science. In the same way, there is no longer a need for the international left-liberals to hate America as part of hating Bush; since Obama, they are free to be more even-handed about America. So perhaps under Obama the Bush-haters will be free to acknowledge the shortcomings of ESC / cloning in a way they couldn’t under Bush.

One problem with the Oprah doc’s comments: there seems to be a pervasive notion that iPS cells, as he said, ‘won’t be as prone to cancer’ as ESCs. I do not agree with this. The teratoma downside is exactly the same. I think Dr Oz is muddling the teratoma risk with the cancer risk associated with viral integration used to obtain iPS (and a further minor muddle - Dr Oz should know that this 'viral cancer' concern has now been laid to rest with virus-free techniques for iPS- see earlier Blog).

I always remind people that iPS cells are no more likely than ESC to be used in direct transplant, as the risk is the same – only adult stem cells can be safely placed in the human body without tumour risk. Conversely, iPS cells are as good as ESC for any research (or generation of transplantable terminal cells) scientists might want to do.

Still, apart from the slight muddle at the edges, this Oprah-Fox moment was highly significant as a breakthrough into public consciousness of the true shape of stem cell science – and as a vindication of the thesis of this website: that cloning is dead, and ESC science is peacefully dying.

For Scholars: iPS journal references up to March 2009

2009-04-14T13:52:00.001+10:00

Please see reference document at http://docs.google.com/View?docID=dcpmpcfg_8dq3k8vcb&revision=_latest

Adult stem cells put to breast use – both cancer and cosmetic

2009-03-30T11:25:00.001+10:00

Yet another ASC good-news story. The regenerative capacity of our own 'adult stem cells' has been proven in such areas as healing chronic wounds of skin or bone. Partly this relates to the stem cells stimulating new blood vessel growth, partly to their generating new connective tissue cells.

This reports a more 'out there' role of ASCs in regenerating fat and connective tissue in breasts. As always, the mice get first trial of the therapies, but now we have formal medical trials in Europe of ASCs to regenerate defects after breast surgery (Dr Weiler-Mithoff is 'impressed with the results') and less formal cosmetic trials in supplementing small breasts (Prof Mokbel of the London Breast Institute says 'This is a very exciting advance').

And without labouring the point, remember that these ASC trials are genuine stem cell transplants, whereas any so-called "trial of embryonic stem cells" must first ensure there is not a single embryonic stem cell within cooey, for the fear of them causing the inevitable tumours... ASCs, by contrast, are safe and reliable for direct therapy in you or me. Which would you prefer under your skin??

Here is the media report, and some excerpts. Medical journal articles will be posted as they become available.

Stem cells to grow bigger breasts

Sarah-Kate Templeton, Health Editor

From The Sunday Times

March 29, 2009

http://www.timesonline.co.uk/tol/news/uk/health/article5993187.ece

(excerpts)

A trial has already started in Britain to use stem cells to repair the breasts of women who have had cancerous lumps removed. A separate project is understood to be the first in Britain to use the new technique on healthy women seeking breast enlargement.

The cells will be isolated from a woman's spare fat, once it has been extracted from her thighs or stomach. The concentrated stem cells will then be mixed with another batch of fat before being injected into the breast. It takes several months for the breast to achieve the desired size and shape.

Professor Kefah Mokbel, a consultant breast surgeon at the London Breast Institute at the Princess Grace hospital, who is in charge of the project, will treat 10 patients from May. He predicts private patients will be able to pay for the procedure within six months at a cost of about £6,500.

*This is a very exciting advance in breast surgery,* said Mokbel.

Until now, when fat was transplanted to the breast without extra stem cells, surgeons had difficulty maintaining a blood supply to the new tissue. Surgeons believe the double concentration of stem cells under this technique promotes the growth of blood vessels to ensure a sufficient blood supply circulates to the transplanted fat.

The same technique has been used in Japan for six years, initially to treat women with breast deformities caused by cancer treatment and, more recently, for cosmetic breast augmentation in healthy women.

Eva Weiler-Mithoff, a consultant plastic surgeon at Canniesburn hospital in Glasgow, is leading the British arm of a European trial of stem cell therapy for women who have been left with breast deformities following removal of cancerous lumps.

So far more than a dozen British cancer patients have been treated and Weiler-Mithoff is impressed with the results. She does not believe this justifies offering the treatment to healthy women, however.

Another path to virus-free iPS: Thomson does it again

2009-03-27T16:51:00.005+10:00

The man who discovered human embryonic stem cells in 1998, and who co-discovered with Yamanaka in 2007 the embryonic-type iPS cells derived from adult cells, has now pushed the science of iPS direct reprogramming a step further. James Thomson was the man who said – re his dual discovery of hESC and their uncontentious successor, human iPS cells – "Isn't it great to start a field and then to end it?"

He has taken a step further towards the end of ESC research - and certainly of its degenerate descendant, cloning –with his elegant demonstration that no virus integration is required to produce successful reprogramming of an adult cell to an embryonic-type cell. His technique differs from that of an earlier post but the outcome is the same: no viral contamination of the resultant pluripotent stem cell.

After the breakthroughs in virus-free iPS this month, there is no longer any excuse for politicians or scientific lobbyists to denigrate iPS technology because of the 'virus / cancer' risk. That will not, however, stop them repeating this outdated propaganda – be sure, even next year in the Senate debate on the review of our cloning legislation in the light of the new iPS alternative, that the "Oh Dear What About The Viruses" card will be played…

Here is the Science journal article link (online publication 26^th March 2009)

Here is the science news report:

Scientists excise vector, exotic genes from induced stem cells

A team of University of Wisconsin-Madison researchers reports that it has created induced human pluripotent stem (iPS) cells completely free of viral vectors and exotic genes.

By reprogramming skin cells to an embryonic state using a plasmid rather than a virus to ferry reprogramming genes into adult cells, the Wisconsin group's work removes a key safety concern about the potential use of iPS cells in therapeutic settings.

The new method, which is reported in today's (March 26) online issue of the journal Science, also removes the exotic reprogramming genes from the iPS equation, as the plasmid and the genes it carries do not integrate into an induced cell's genome and can be screened out of subsequent generations of cells. Thus, cells made using the new method are completely free of any genetic artifacts that could compromise therapeutic safety or skew research results, according to the Science report.

READ THE COMPLETE REPORT

Media Release: Cloning vote in South Australia succumbs to false science

2009-03-26T16:49:00.001+10:00

CLONING VOTE IN SOUTH AUSTRALIA SUCCUMBS TO FALSE SCIENCE

Leading scientists criticized for misleading MPs

"A narrow majority of South Australian Upper House MPs, after a debate marred by scientific error and ethical muddle, have approved the creation of second-class, expendable human lives", said Dr David van Gend, National Director of Australians for Ethical Stem Cell Research.

"They have approved the once-unthinkable: the cloning of living human embryos - not destined for birth (like IVF embryos), but destined solely for research and destruction.

"They have done so even though cloning has now been rendered redundant by the entirely ethical technique of 'iPS direct reprogramming' of adult cells. (See http://www.onlineopinion.com.au/view.asp?article=6970)

Dr van Gend criticized scientific lobbyists in South Australia for misrepresenting the science in order to influence the vote: "It is a serious distortion of democracy when MPs, who have no scientific training, can be influenced by scientific arguments that carry the authority of an impressive letterhead, but lack the authority of truth".

"South Australian MPs have supported cloning largely because some scientific heavyweights, in a joint letter, managed to persuade them:

about the alleged importance of cloning for stem cells
about the alleged problems with the iPS alternative.

On the first point, the scientists wrote to MPs (copy of letter available) that:

'Therapeutic cloning would allow patients to have personalised stem cells which would allow disease-specific cell lines to be made which could be used to study a disease and test drugs.'

"That scenario, however speculative, might have been compelling for other Parliaments who voted for cloning", Dr van Gend said, "because in good faith they believed that cloning was indeed the only possible technique to obtain 'personalised stem cells'.

"But since November 2007, the claim of 'uniqueness' is no longer valid. As leading researcher Jack Martin, Emeritus Professor of Medicine at the University of Melbourne, wrote to South Australian MPs:

'The scientific situation has changed dramatically. Published reports in late 2007 showed that (they) could induce pluripotent stem (iPS) cells, first from mouse, then human adult cells. These iPS cells have been shown to have all the properties previously attributed to embryonic stem cells, and thus provide a means of preparing individually "tailored" pluripotent cells without the major ethical problems involved in "therapeutic cloning".'

Dr van Gend said, "Therefore the essential task for pro-cloning lobbyists was to discredit in the minds of MPs this new ethical alternative to cloning. That is what the scientists did in their letter to MPs. Yet their scientific argument was regrettably incomplete at the time of writing, and obviously false at the time of the vote".

The letter had stated:

"These adult-derived stem cells are genetically modified with viruses. They contain multiple copies of a particular transcription factor, they do not have the same expression pattern as embryonic stem cells and we do not know if they can do everything embryonic stem cells can do. The transcription factors may also be oncogenic (i.e. cancer-causing)."

"That is not a fair representation of the science", Dr van Gend said. "Surely these scientists knew that Dr Shinya Yamanaka, who first created iPS cells in mice and then humans, had already published in Science in September showing that such cells can be created without any genetic modification with viruses? No concern with them being 'oncogenic', no interference with the expression pattern – in short, no virus integration at all. So why was this not disclosed to MPs? [See http://www.sciencemag.org/cgi/content/abstract/1164270]

"And why did these scientists not inform MPs when the further demolition of their 'virus/cancer' argument was published in Nature, weeks before the vote? [See: http://ethicalstemcellresearch.blogspot.com/2009/03/media-release-stem-cell-breakthrough.html]

"It is not good enough for leading scientists to 'spin' the science to achieve a political outcome", Dr van Gend said. "South Australian Upper House MPs have been subtly misled, and have voted to permit research that is, in truth, both unnecessary and unethical".

"Unlike their counterparts in the Western Australia Upper House last year, who rejected cloning, these MPs were not able to grasp that we are in a new era of stem cell science, where the old arguments for cloning are no longer valid."

"It is now up to wiser heads in the Australian Senate to axe this redundant and inhuman science, when the Federal Act comes up for review next year" Dr van Gend concluded.

ENDS

Dr David van Gend

National Director, Australians for Ethical Stem Cell Research

iPS indistinguishable from ESC (so what is the ‘gold standard’ and what is the fool’s gold?)

2009-03-20T09:30:00.002+10:00

Here is yet another example of the iPS technology that has transformed stem cell science since November 2007: taking an adult cell (this time from a blood sample) and turning it into the exact equivalent of the pluripotent stem cells extracted from embryos (which become dead embryos in the process).

This report, published 18^th March, is useful for listing the strict and comprehensive criteria by which the iPS cell is tested against ESC properties. In every way, they are identical. The same. No different.

There is much chatter about still needing ESCs as 'the gold standard' to test iPS cells against. This is the current residual argument scientists have to justify the dying science of embryo exploitation. But it is increasingly a standard of fool's gold. ESCs show no advantage over iPS and plenty of disadvantages: because they come from IVF embryos they do not match the patient, whereas iPS exactly match the patient; if they were to come from cloned embryos (and remember nobody has ever got a single ESC from a cloned human embryo, despite the millions spent) then they still, dear reader, do not match the patient – as cloning still incorporates foreign DNA from the mitochondria of the donor egg.

Smart private 'gold' is not going to chase the fool's alternative of ESCs from IVF embryos or from cloned embryos. Only dumb 'public' gold will do that – while certain scientists continue to dupe politicians about the 'gold standard' of ESCs…

And so to the key paragraph of this article:

Generation of induced pluripotent stem cells from human blood Yuin-Han Loh, Suneet Agarwal, In-Hyun Park, Achia Urbach, Hongguang Huo, Garrett C. Heffner, Kitai Kim, Justine D. Miller, Kitwa Ng, and George Q. Daley*

Blood First Edition Paper, prepublished online March 18, 2009; DOI 10.1182/blood-2009-02-204800.

http://bloodjournal.hematologylibrary.org/cgi/content/abstract/blood-2009-02-204800v1

"Blood derived human iPS cells are indistinguishable from human embryonic stem (ES) cells with respect to morphology, expression of surface antigens and pluripotency-associated transcription factors, DNA methylation status at pluripotent cell-specific genes, and the capacity to differentiate in vitro and in teratomas. The ability to reprogram cells from human blood will allow the generation of patient-specific stem cells for diseases in which the disease-causing somatic mutations are restricted to cells of the hematopoietic lineage."

More nails in cloning’s coffin - Frankenbunny RIP, ovarian hyperstimulation causes cancer…

2009-03-17T13:55:00.003+10:00

The first entry in our former Blog was devoted to those disturbing little pets, the animal-human hybrid embryos.

At the time we noted: "Accessing the thousands of human eggs needed for cloning risks the lives and wellbeing of women (through ovarian hyperstimulation syndrome, which killed one IVF patient last month in Britain), but the rabbit option Trounson pulled out of his hat is equally unthinkable."

Professor Alan Trounson had commented in 2005, "Since there are plenty of rabbit eggs around, if we could make that work it would remove the concern about accessing human eggs in any numbers".

Last month, both scenarios – the ovary-as-commodity or the rabbit-as-mother - took potentially fatal blows.

Concerning ovarian hyperstimulation: the Journal of Epidemiology published findings that use of ovarian hyperstimulation was associated with a 36% increased risk of developing cancer.

In particular: "Treatment with ovulation-inducing drugs increased the risk of breast cancer by 42 percent; uterine cancer risk by more than 3-fold, and the risk of non-Hodgkin lymphoma by about 2.5-fold. Treatment with the ovulation-inducing drug clomiphene specifically was associated with 4.6-times the risk of uterine cancer and 2.6-times the risk of malignant melanoma."

So the proposal - giving a little extra ovary stimulation to provide scientists with a few nice fresh eggs for cloning – is more on the nose than ever.

That takes up back to Trounson's rabbits. Fortunately, the Senate in Australia threw out the provision for animal-human hybrids, but in the US and UK it has proceeded apace. How pleasing, then, to read the research from a leading cloning lab, Advanced Cell Technology in Boston, showing that these hybrids are non-starters. That animal eggs simply speak a different language to human eggs; they are out of synch with the human nucleus, and reprogramming the human DNA is a failure.

To borrow the succinct summary from Michael Cook at Bioedge (one of our favoured websites):

"Robert Lanza of Advanced Cell Technology, a California stem-cell company, published a paper in the journal Cloning and Stem Cells, which showed that human-cow, human-mouse and human-rabbit hybrid embryos fail to grow beyond 16 cells.

"There is no evidence that patient-specific human stem cells can be generated using animal oocytes," his team concluded. Genes thought to be critical for pluripotency -- the ability to develop into a wide variety of cell types - also failed to express properly. "At first we thought it would just be a matter of tweaking the culture conditions," Lanza told Nature. But "the problem was far more fundamental".

Critics of the hybrids felt vindicated. A British scientist commented on Nature's blog recalled that "Those who questioned the ethics or the prospects of this technology had to face angry patients who had been convinced that cybrids would be the holy grail that would cure them." He contended that "high profile public hyping of very speculative proposals, like cybrids, is a disservice to the public and to science".

But it was a bitter disappointment for scientists who had hoped that they could get pluripotent stem cells without having to use human eggs, which have proved all but impossible to obtain ethically in the vast quantities required for serious research.

The unpalatable conclusion seems to be that the supernova of "therapeutic cloning" is fading. ~ AFP, Feb 2;

One can only hope. Again, as we concluded our first Blog on the old site:

"No human cloning! Cloning violates our humanity, not only in creating embryos who have no identifiable human mother – just an emptied out egg nearly devoid of her genetic identity – but in proposing the further dehumanisation of an animal egg where the mother's egg should be."

Adult stem cells used safely in spinal cord injury

2009-03-13T17:40:00.002+10:00

All attention is on Obama's funding of close-to-futile ESC research and Geron Corp's dubious and potentially catastrophic trial of nerve cells derived from ESCs (see last post).

Meantime, here is an ASC trial in spinal cord patients (news release today US time) - showing no tumour formation, no adverse effects, and (like the earlier Portugese study at http://www.apssci.org/pdf/olfactory.pdf) subtle early benefit to patients. Early days, but safe and promising. And uncontentious.

This is the great future of stem cell therapy – entirely ethical, safe from the problems plaguing ESCs – and yet you can bet the newspapers will hardly mention it. Not sexy. Of no value in the culture wars; not useful for rubbing 'conservative' noses in the dirt.

For readers who have no prejudice against great science that happens to be supportive of human values, read this report out today on Science Daily – and the abstract of the article below.

Multiple Route Bone Marrow Stem Cell Injections Show Promise To Treat Spinal Cord Injury

http://www.sciencedaily.com/releases/2009/03/090312130650.htm

Journal article

http://www.ingentaconnect.com/content/cog/ct/2008/00000017/00000012/art00001;jsessionid=3bbrli6xw3s0b.alice

Geron ‘Claytons’ ESC trial – scientists and smart money smell a rat

2009-03-13T13:12:00.007+10:00

You could not have missed the news that at last, embryo stem cells are to be given to humans! Surely this is the vindication of all the snake-oil about ESCs being used to treat humans?

Wrong, of course. As we explained in our Media Release in January, the Geron trial does not let an ESC within a mile of any patient's spine – that would be to invite disaster in the form of tumour formation. Being very patient, we reminded journalists again of the true shape of stem cell 'therapy':

"Journalists and the public need to be told the truth – not sneaky suggestions that 'embryonic stem cells' are being given to patients at last!! They are not. Repeat: they are not. They never have been and never can be put into humans, because embryonic stem cells form tumours in animals. Only adult stem cells can be put into humans – and have been used now successfully in thousands of patients."

In fact, we explained this as far back as October last year when Professor Alan Trounson was using the planned Geron trial to salvage some vestige of relevance for ESC research. In our October 27^th Media Release 'Phoney Breakthrough with Embryonic Stem Cells' we said:

"There is only one way, paradoxically, for embryonic stem cell trials to proceed and that is for researchers to find a way to ensure that absolutely no embryonic stem cells (ESCs) are used in the trial!

"ESCs themselves are dangerous, since they form tumours called teratomas, and in the scientific literature ESCs are referred to as 'rogue cells' or 'unwanted differentiating types'. The task of Geron Corp and others is to 'terminally differentiate' all ESCs into other, mature cells – a bunch of nerves, perhaps, or heart muscle cells – but above all, no ESCs please!

"This is not a stem cell transplant, this is not ESC therapy – it is just transplanting a bunch of mature cells, with no capacity to regenerate themselves. This is not a 'revolution' in regenerative medicine; it is scientific sleight of hand.

Geron's is a Clayton's ESC trial: the ESC trial you have when you are not having an ESC trial, etc… Yet it will do for journos and pollies eager to justify the increasingly redundant field of ESC research.

However, it appears it is not good enough for smart private money and some sensible stem cell scientists.

Read here only this week in the investment journal Street.com about the investors' suspicions:

"Wall Street's health care investors, most notably biotech-focused hedge funds, have been more inclined to steer clear of Geron or short the company's stock.

The reason?

"Conference calls for Wall Street health care investors with experts critical of Geron's research, like those held by Summer Street Research on Monday, explain why.

And what said the expert on the conference call? He said the same as we have always said: that the "white-rat-walking" videos (whether Geron's or the famous Gearhart video used so misleadingly by Prof Trounson with our MPs back in 2003) are highly dubious when extrapolated to human spine injury of treatment; that the transplanted nerve cells (not ESCs) are 'foreign' (extracted from a deceased human embryo) and therefore the patients need immune suppression; and that even if Geron did publish 22,000 pages of research to get its experiment permitted, that will not stop some of these cells possibly reverting to the dreaded ESC and forming a tumour. That, says the specialists, would be a disaster.

Here is the central part of his reported comments:

The doctor on the Summer Street conference call, a spinal cord injury expert who has also conducted stem cell research, was skeptical about Geron's study because there is very little animal data to support the theory that a therapy derived from stem cells will benefit patients with severe spinal cord injury.

"The fact that Geron's entire study hinges on this one experiment in eight moderately injured rats is tenuous in terms of efficacy," he said.

The experiment referred to, conducted by Dr. Hans Keirstead of the University of California at Irvine, was done on eight rats whose spinal cords were purposefully injured to paralyze the hind legs. Rats treated with the Geron therapy after seven days saw some function return to their paralyzed legs. Geron commonly shows a video of the rats before and after treatment as part of the company's pitch to investors.

The doctor warned, however, that the rats in the experiment only had moderate spinal cord injury, while human patients in Geron's first safety study will have severe spinal cord injury. Moreover, when the same rat experiment was conducted in rats with severe spinal injuries or when the start of treatment was delayed for more than a week, the Geron therapy had no effect.

The Geron therapy is derived from a universal donor stem cell line that will be considered foreign by patients. As a result, patients will need to be placed on drugs that suppress their immune systems to lower the risk that the Geron therapy is rejected.

"We don't know what will happen when these cells are placed into a human, which is the reason immune suppression is required," said the doctor on the Summer Street conference call. "The risk is that these are not patients you would otherwise want to have on immune suppressants because the severity of their spinal cord injuries, the trauma they've suffered, their surgery and wounds make them more susceptible to infection."

Moreover, the doctor said, patients' bodies may reject the Geron therapy as soon as immune suppression drugs are stopped after 42 days, per the study's protocol. Typically, when a patient undergoes some type of transplant, immune suppression therapy is required for life.

Another safety concern is the risk that the cells in Geron's therapy may grow uncontrollably and form tumors on the spinal cord. Geron has stated that tumor growth has not been detected in any of its animal studies, but again, the theoretical risk remains when Geron moves its therapy into humans.

"If one patient gets a tumor from the Geron therapy, it will be catastrophic," said the doctor on the Summer Street call.

Why, given the drawbacks of immune suppression and tumour risk, and a dodgy animal basis for doing the experiment in the first place, would the FDA approve this trial?

And why, in all the science journalistic coverage of this alleged new frontier of spinal 'treatment', did they not even acknowledge that we have already done this trial using adult stem cells? They can't say they weren't told, as we gave them chapter and verse in the January MR. Our comment then remains our judgement on the Geron trial (and associated market and media hype):

We already have a published article in the Journal of Spinal Cord Medicine (http://www.apssci.org/pdf/olfactory.pdf) using an adult stem cell preparation in human spinal cord injury, with no harm to the patients, and early signs of recovery of sensation. We also have over 2000 patients treated with direct adult stem cell transplant for heart disease, with exciting results, and thousands of other patients treated for dozens of medical conditions – including diabetes – all published in the medical journals. There has never been a single human treated using embryonic stem cells – and even this Geron experiment is a hoax, as it does not inject embryonic stem cells at all.

This Blog will watch the Geron experiment closely; and we give unsolicited financial advice that you would do well not to sell all to buy GERN.

‘Why Embryonic Stem Cells are obsolete’ – the former head of the National Institute of Health, US

2009-03-11T09:56:00.001+10:00

Why Embryonic Stem Cells Are Obsolete

March 04, 2009 Bernadine Healy, M.D.

http://www.usnews.com/blogs/heart-to-heart/2009/3/4/why-embryonic-stem-cells-are-obsolete.html

Scientists may be growing impatient, but President Obama has been rightly taking his time in addressing a campaign promise to lift the ban on federal funding for research using new lines of stem cells to be taken from human embryos. Even for strong backers of embryonic stem cell research, the decision is no longer as self-evident as it was, because there is markedly diminished need for expanding these cell lines for either patient therapy or basic research. In fact, during the first six weeks of Obama's term, several events reinforced the notion that embryonic stem cells, once thought to hold the cure for Alzheimer's, Parkinson's, and diabetes, are obsolete. The most sobering: a report from Israel published in PLoS Medicine in late February that shows embryonic stem cells injected into patients can cause disabling if not deadly tumors.

The report describes a young boy with a fatal neuromuscular disease called ataxia telangiectasia, who was treated with embryonic stem cells. Within four years, he developed headaches and was found to have multiple tumors in his brain and spinal cord that genetically matched the female embryos used in his therapy.

His experience is neither an anomaly nor a surprise, but one feared by many scientists. These still-mysterious cell creations have been removed from the highly ordered environment of a fast-growing embryo, after all. Though they are tamed in a petri dish to be disciplined, mature cells, research in animals has shown repeatedly that sometimes the injected cells run wildly out of control-dashing hopes of tiny, human embryos benignly spinning off stem cells to save grown-ups, without risk or concern.

That dream was still alive only a few weeks before this report. Within days of Obama's inauguration, the Food and Drug Administration approved its first-ever embryonic stem cell study in humans: the biotech company Geron's plan to inject highly purified human embryonic cells into eight to 10 patients with acute spinal cord injuries. (The cells are from a stem cell line approved by Bush because it predated his ban.) The FDA should now be compelled to take another look: Are eight to 10 patients enough, or one year of monitoring sufficient, to assess safety? And doctors who participate in the trial will have to ask what every doctor must ask before performing research on a human subject: Were I this patient, would I participate? Would I encourage my loved ones to do so?

Even as the future of embryonic stem cells has dimmed, adult stem cell research has scored major wins evident just in the past few months. These advances involve human stem cells that are not derived from human embryos. In fact, adult stem cells, which occur in small quantities in organs throughout the body for natural growth and repair, have become stars despite great skepticism early on. Though this is a more difficult task, scientists have learned to coax them to mature into many cell types, like brain and heart cells, in the laboratory. (Such stem cells can be removed almost as easily as drawing a unit of blood, and they have been used successfully for years in bone marrow transplants.)

To date, most of the stem cell triumphs that the public hears about involve the infusion of adult stem cells. We've just recently seen separate research reports of patients with spinal cord injury and multiple sclerosis benefiting from adult stem cell therapy. These cells have the advantage of being the patient's natural own, and the worst they seem to do after infusion is die off without bringing the hoped-for benefit. They do not have the awesome but dangerous quality of eternal life characteristic of embryonic stem cells.

A second kind of stem cell that has triumphed is an entirely new creation called iPS (short for induced pluripotent stem cell), a blockbuster discovery made in late 2007. These cells are created by reprogramming DNA from adult skin. The iPS cells are embryonic-like in that they can turn into any cell in the body-and so bypass the need for embryos or eggs. In late February, scientists reported on iPS cells that had been transformed into mature nerve cells. While these cells might become a choice for patient therapy in time, scientists are playing this down for now. Why? These embryonic-like cells also come with the risk of cancer.

James Thompson, the stem cell pioneer from the University of Wisconsin who was the first to grow human embryonic stem cells in 1998, is an independent codiscoverer of iPS cells along with Japanese scientists. Already these reprogrammed cells have eclipsed the value of those harvested from embryos, he has said, because of significantly lower cost, ease of production, and genetic identity with the patient. They also bring unique application to medical and pharmaceutical research, because cells cultivated from patients with certain diseases readily become laboratory models for developing and testing therapy. That iPS cells overcome ethical concerns about creating and sacrificing embryos is an added plus.

The importance of stem cells for medical research has never been greater, and the scientific and public clamor for unimpeded research is fully understandable. But it's important that Obama and everyone supporting a lifting of the ban be clear with the public on what is involved in this decision; it's more complex than advertised. The ban Bush became famous for restricted the use of federal research dollars just to adult stem cells and embryonic stem cells already in existence at the time of his executive order. Lifting this ban so that researchers can use frozen embryos that would otherwise be discarded-they've been donated by couples who have had in vitro fertilization treatments-has drawn wide and bipartisan support from Congress. It's an easy lift.

The more ethically charged decision-less understood by the public and one Congress has avoided-involves the ban on creating human embryos in the laboratory solely for research purposes. In fact, President Clinton is the one who balked at allowing scientists to use government money for embryo creation and research on stem cells harvested from such embryos; Bush only affirmed the Clinton ban. The scientific community has been able to attract nonfederal money for such work, and it is going on all the time in stem cell institutes. Scientists want relief from the inconvenience and expense of keeping that work and the money that supports it separate from federal dollars.

Reversing the executive orders of two prior presidents on embryo creation, which even the Congress has been unwilling to tackle, is a far bigger issue than lifting the ban on the use of IVF embryos slated for destruction. Obama stands for transparency, and it's important for him to make sure the public understands his decision, including that all stem cells are not the same or created equally.

Media release: OBAMA FLOGS DYING HORSE ON EMBRYO STEM CELLS

2009-03-10T13:43:00.001+10:00

FOR IMMEDIATE RELEASE – Tuesday March 10th 2009.

“President Obama’s repeal of restrictions on embryonic stem cell research will have little impact on the new, embryo-free, era of stem cell science” said Dr David van Gend, National Director of Australians for Ethical Stem Cell Research.

“Cloning died, and embryonic stem cell science entered death row, in November 2007, with the advent of ‘direct reprogramming’ of adult skin cells to the exact equivalent of embryonic stem cells” Dr van Gend explained. [See his article at http://www.onlineopinion.com.au/view.asp?article=6970]

“No longer are embryos the only way to obtain these specialised ‘pluripotent’ stem cells; no longer is cloning the only way to get patient-matched embryonic-type stem cells. The superior, and ethically uncontentious new science of iPS reprogramming has left cloning and embryo experimentation to wither on the vine”.

“All that scientists can say now to justify embryo stem cell research is that they need it as a ‘standard of comparison’ with the new iPS cells. Embryo cells are playing second fiddle to iPS cells – because only iPS cells exactly match the patient, and only iPS cells can be created easily in labs around the world, without any ethical concerns.

“Consider the mixed messages coming to Obama from the scientists themselves. Obama has asked the National Institute of Health (NIH) to devise guidelines for further embryo research – yet the former director of the NIH, Dr Bernardine Healy, wrote an article only this week on “Why embryonic stem cells are obsolete.” (see http://www.usnews.com/blogs/heart-to-heart/2009/3/4/why-embryonic-stem-cells-are-obsolete.html)

“Gone are the days of snake-oil scientists promising miracle cures from embryos. Here are the days of ethical stem cell research that does not violate human life in the process.

“Obama is keeping his promise to cultural ‘progressives’, who want yet another assertion from this extreme pro-abortion President that life before birth is to be trampled underfoot. For science, however, his promise of increased funds for embryo exploitation is flogging a dying horse, and will not alter the new, entirely ethical course of stem cell research.”

ENDS

Media Release - Stem Cell breakthrough: virus-free iPS cells

2009-03-09T16:19:00.002+10:00

FOR IMMEDIATE RELEASE – Monday March 2nd 2009.

ANOTHER NAIL IN CLONING’S COFFIN – IN TIME FOR SA VOTE

“Today’s ethical stem-cell breakthrough, published in the leading scientific journal Nature, is another nail in the coffin for cloning” according to Dr David van Gend, National Director of Australians for Ethical Stem Cell Research.

• The story was embargoed until early this morning, and broke today at the BBC: ‘Ethical stem cell creation hope’ at http://news.bbc.co.uk/2/hi/health/7914976.stm

• The Nature title is: Virus-free induction of pluripotency and subsequent excision of reprogramming factors
http://www.nature.com/nature/journal/vaop/ncurrent/abs/nature07864.html

“In a beautiful technical advance, scientists have managed to insert reprogramming genes into ordinary human skin cells to achieve full pluripotency (i.e. the equivalent of Embryonic Stem Cells) without using any viral vectors” Dr van Gend explained.

“This furthers the revolution of ‘iPS direct reprogramming’, dating to November 2007, whereby we can now create the equivalent of embryonic stem cells from our own body cells, without ever using women’s eggs or cloning a human embryo – and that removes all the ethical concern from this magnificent field of medical research.”

Dr van Gend points to the fact that the Upper House of Western Australia threw out a cloning Bill in February 2008, in the light of this new iPS technique that “makes cloning redundant as well as wrong”, and that the South Australian Upper House is considering the same cloning legislation this week.

“Importantly, there have been concerns raised in the course of parliamentary debates on cloning laws that iPS cells are impaired by the need for viral integration during the process of 'direct reprogramming' - which could cause genetic damage.

“Now, on the eve of the cloning vote in the South Australian Legislative Council, MPs can rest assured that the concerns over viral integration have been laid to rest. This new, ethical stem cell science appears to be unstoppable – and already we have dozens of pluripotent stem cell lines derived from patients with important diseases like Parkinson’s and Motor Neuron Disease”.

Dr van Gend’s association has written to all members of the Legislative Council of South Australia: ”There could be no more timely scientific breakthrough than this, to confirm for you that creating and destroying cloned embryos for stem cells is yesterday's redundant science: that while embryo-cloning might have been supported in good faith in the pre-iPS era, its unique justification no longer exists. No cloning legislation would have seen the light of day in the Federal Parliament if they had known in 2006 what you know now.” ENDS

From Feb 2008: Obituary for the first Human Clone - and for Cloning

2009-03-08T15:15:00.000+10:00

Has there ever been a greater anticlimax in science than the announcement on January 17 2008 that, at last, a cloned human embryo had been created? Even a few months ago the news would have flooded the world’s media; now it hardly rates a mention. The reason is clear: on November 21 2007, cloning as a serious science suddenly died, and was superceded by a technique so simple and powerful (and entirely ethical) that it has left the world of stem cell research both stunned and elated.

The cloning experiment published in January in the journal Stem Cell was performed a full year ago, in the bygone era when scientists still believed cloning was the only way to get hold of specialised embryonic stem cells. That is no longer the case, and no scientist in 2008 has any compelling reason to attempt human cloning. As news, this ‘breakthrough’ is out of date even before publication; it is an ugly artifact of the brief and unlamented era of cloning.

In November 2007 two teams of scientists published a new technique of ‘reprogramming’ adult cells to an embryonic state without ever creating or destroying a human embryo. This had been proven in animal models earlier that year, and within months was confirmed in humans. These ‘induced pluripotent stem cells’ (iPS cells) show all the properties of cloned embryonic stem cells, but are obtained easily and ethically by simple manipulation of the skin cell of an adult.

This is good news for science, which has still never been able to obtain a single stem cell by cloning embryos, and even better news for those of us who find it unthinkable that embryonic humans should be created with the sole purpose of destroying them in research.

The potential for this development to bypass the central ethical objection to cloning was recognized immediately by Professor Loane Skene, former Chair of the Lockhart Review which advised the Government in 2005 to permit cloning. On the day the iPS research was published she responded: "What this does is take away the step of using the egg, and creating the embryo which is particularly ethically contentious and it offers the opportunity to get stem cells that are matched to a particular person."

Most remarkable has been the graciousness with which leading advocates of cloning have accepted its demise, and moved wholeheartedly towards the ethical new science of reprogramming adult cells.

First Professor Ian Wilmut, who cloned Dolly the sheep and holds the UK license to clone humans, announced in November that he was walking away from his cloning license in favour of iPS reprogramming, which he declared to be both “100 times more interesting” and “easier to accept socially”.

At the same time Professor James Thomson, who first discovered human embryonic stem cells, proved that these new iPS cells derived from human skin had every property of cloned embryonic stem cells, and declared "Isn't it great to start a field and then to end it?"

Other overseas scientists and ethicists describe this discovery as “an earthquake for both the science and politics of stem cells’, and as the ‘Holy Grail’ of stem cell science. One cloning expert says that the ethicists will just have to find something else to worry about now!

Leading Australian experts like Professors Alan Trounson, and Richard Boyd also indicate the shift away from cloning to this new alternative. They appreciate the freedom from ethical concerns, including the troubling question for cloning of ‘Where will all the eggs come from?’

And last month in the journal Nature, the former Director of Embryonic Stem Cell Research at the Australian National Stem Cell Centre, Professor Martin Pera, writes of “a new year and a new era”. It is a happy era where there is no conflict between stem cell science and basic human dignity: “The generation of iPS cells through direct reprogramming avoids the difficult ethical controversies surrounding the use of embryos for deriving stem cells.”

Initial concerns that the technique used viral vectors which might provoke tumours were settled quickly, as the offending viral vector was shown to be unnecessary; such is the intensity of research in this new field that concerns raised at dawn are settled by sundown.

There are no remaining uses for cloning – only abuses – and because these abuses are now possible, they demand proactive legislation nationally and internationally. The act of cloning, so shamefully achieved by the scientists at Stemagen, is itself an abuse - creating, for the first time ever, a living human embryo with no natural parents. No mother to protect it. A child of the laboratory, created for death, not for life. But there is much worse to come if this abusive technique is allowed to be perfected.

We know that certain overseas doctors fully intend to be the first to bring a cloned embryo to birth. They are supported by academics like Melbourne’s Daniel Elsner, who wrote in the prestigious Journal of Medical Ethics in 2006: “People who wish to reproduce by cloning should be permitted to do so, provided there is no reasonable alternative.”

And far worse, we have the sick proposal to farm cloned fetuses for their organs – proposed in the same journal by another Melbourne man, Julian Savulescu, who is the Professor of Practical Ethics at Oxford. In an article entitled “Cloning as a source of transplant tissue” he writes: “It is morally required that we employ cloning to produce embryos or foetuses for the sake of providing cells, tissues or even organs for therapy, followed by abortion of the embryo or foetus.”

These abuses would never happen in Australia, but are sure to be attempted by rogue doctors in less regulated countries. Therefore we need to revisit and empower the United Nations resolution of 2006 which called for a ban on human cloning.

More immediately, Western Australia and South Australia legislators are about to vote on cloning, and have the chance to reverse the tide on national legislation which has been based on a scientific illusion. They can now, with good conscience and better science, reject a practice which has always been unethical, but is now clearly unnecessary.

Instead, let us all support stem cell science which is both effective and ethical, which gives us hope but does not degrade our humanity.