Tuesday, November 15, 2011

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

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!

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.

Tuesday, November 8, 2011

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

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.


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.

Saturday, November 5, 2011

QUADRANT ARTICLE: "Cloning - the Blighted Science"

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.