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

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

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

 

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:

1. about the alleged importance of cloning for stem cells
   
2. 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?)

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…

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

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

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

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

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

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

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.