The Niche

There’s a lot of reading material on the fact that Geron now has the FDA’s blessing to start a clinical trial for spinal cord injury using cells derived from embryonic stem cells. But some of the patients who have been waiting most eagerly for this announcement will be disappointed. The trial, which is expected to begin this summer, will only accept patients whose injuries occurred recently, within a week or two of the experimental treatment.

Coverage by Nature points out that other companies hoping to use embryonic stem cells for therapies are coaxing them into very different types of cells. It quotes Sean Tipton, former head of the Coalition for the Advancement of Medical Research "This is a trial of one particular application, not a trial of all embryonic stem cells."

The New York Times article explores the repercussions of what might happen if this trial disappoints or worse. (A topic Nature Reports covered more generally in Weighing risks and rewards on the way to the clinic.)

There is also an in-depth piece by Wise Young, the Rutgers neuroscientist who works tirelessly to investigate and explain emerging scientists to the spinal cord injury community. He puts the work leading up to the trial in context and then explains what it will mean for those already injured.

California Stem Cell Report’s David Jensen has a round-up of the coverage, with quotes from what he calls “not-so-ebullient views.” He also has posts on following Geron’s stocks, and a grateful note from a stem cell advocate.

In my first post announcing the trial, I included links to many of the questions raised as well as the context leading up to the trial.

Posted by Monya Baker on January 28, 2009
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The FDA has given permission for Geron to try an embryonic stem cell based therapy for spinal cord injury in up to 10 patients. The approval was granted on Wednesday, just a day after Barack Obama's inauguration as president, but both FDA and Geron say the timing is coincidental, according to an article in the Wall Street Journal.
Here is a press release from the company.

In spring last year, the FDA refused to let the trial go ahead. Analysts and advocates I spoke to were convinced this was because of political reasons, but that opinion was not shared by the half-dozen or so scientists I spoke with (some of whom credibly claimed inside knowledge of the proceedings). Though embryonic stem cells have potential to become any sort of cell in the body, regulators, scientists, and others worry that the cells are unpredictable. Since spinal cord injury is not a fatal disease, regulators fear that an experimental therapy that goes wrong could shorten someone's life. At the FDA hearing I attended in April last year, patient advocates pled with regulatory officials to consider quality and not just length of life when weighing the potential risks and benefits of a new treatment.

Here are some related articles:
Weiging risks and rewards on the way to the clinic
What stem cell therapy can learn from gene therapy
FDA places Geron's clinical-trial on hold (free blog from May 2008)
Embryonic stem-cell trial placed on hold (subscription news from May 2008)
FDA to vet embryonic stem cells' safety (subscription news, preview of the meeting)
FDA questions on making safe products from embryonic stem cells

Posted by Monya Baker on January 23, 2009
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ReNeuron has just received permission to launch a clinical trial for stroke patients using neural stem cells. About a dozen patients will receive the cells at Southern General Hospital in Glasgow, Scotland. An article in the Financial Times chronicles the path to obtain regulatory permission to launch the trial in the UK. An article in NatureNews describes how the cells, derived originally from aborted fetuses, have been genetically engineered with an inducible gene to control cells’ growth. The prospect of transplanting genetically engineered cells worried advisors to the FDA’s panel on starting clinical trials with embryonic stem cells last year, though Geron is still pressing ahead on this front.

Also, read about clinical trials underway with Osiris from a recent interview with the CEO Randall Mills.

For more information, see my December post on other non-embryonic stem cell trials that have launched recently.

Posted by Monya Baker on January 22, 2009
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When Obama was elected, advocates for embryonic stem cell research rejoiced merely at the prospect of fewer funding restrictions. Now they are developing policy recommendations.

Here’s a round-up of what three groups are advocating, all recommend lifting the federal funding restrictions. Everyone expects that to happen, though there is some speculation, that he'll work with Congress to lift the ban rather than using an executive order. (See story in Newsmax.)
Also, here's a subscription-only piece in Nature Medicine, Challenges anticipated in removal of embryonic stem cell restrictions, which concludes that just lifting the ban will not open floodgates of new research.

The most specific requests are contained in 40-pages from the American Progress group, whose leader, John Podesta, is on leave to advise the Obama transition. A Life Sciences Crucible: Stem cell research and innovation done responsibly and ethically offers specific guidelines to the President, Congress, and NIH, and for establishing the best national stem cell registry and stem cell bank. In particular, the report suggests provisions for stem-cell research coded into federal legislation and suggests that the role of the Recombinant DNA Advisory Committee (RAC ), which reviews human gene-therapy protocols, be expanded to review cell therapies as well. In a position that many scientists will disagree with, the report commends WARF for striking a good balance in protecting investments and allowing research to proceed. In a position most scientists will support, states funding stem-cell research are urged not to drop their efforts.

The Coalition for the Advancement for Medical Research has its 11-page A Catalyst for Cures: Embryonic Stem Cell Research, aimed more at the public than informed policymakers. This report says that ES cell research has come a long, long way, with cells that can now be coaxed into neurons, heart muscle and more. However, ES cell research has even further to go before the cells can be used for practical applications. These include drug testing and modeling disease in a dish. From page 9 on, the report summarizes progress on specific diseases and research investments in companies. It also points out that research takes a long time: it took 45 years after poliovirus was isolated before the Salk vaccine was produced.

The Center for Genetics and Society has a nine page report, three pages of which focus on stem cells. CGS supports human ES cell research, but has spoken out against therapeutic cloning because the experiments require eggs to be collected from women, and the group worries that the technology could be applied to reproductive cloning. Its recommendations call for legislation to prohibit human reproductive cloning (but not therapeutic cloning) and make Stem Cell Research Oversight committees accountable to the NIH. It also calls for greater study and public discussion of issues raised by human biotechnology, as well as federal oversight of assisted reproductive technology.

Finally, Harvard professor and former president of the International Society for Stem Cell Research puts forth his recommendations in a collection of advice from experts ranging from climate change, FDA, and infrastructure. (It's the final essay in this collection. Your inbox, Mr. President)

If I’ve missed your group, send an email to the Niche at nature dot com.

Posted by Monya Baker on January 20, 2009
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Everyone wants to cash in on the excitement surrounding stem cells. This week, Bryn Nelson reports on how this is playing out in high-end skin products (A superficial success).

Other stories about companies that market products directly to consumers include Stem-cell banking: lifeline or sub-prime? and several articles on the unregulated clinics offering more hope than evidence in their promises to cure serious diseases: (Stem cell researchers face down stem cell tourism, Offshore stem cell treatments and Stick to the guidelines and fewer get hurt).

I commissioned the cosmetics feature after receiving an advertisement for a ‘FROZEN STEM CELL FACIAL’ (Perhaps it works better in ALLCAPS). I called the spa and asked where the cells were from. “Paris,” came the reply. I was told they were “bovine” upon further query. Shortly thereafter, I received an e-mail from DeCouverte Cosmetique advertising a skin product that promised to give my skin the “post-conception glow” of pregnant women. The secret ingredient? Tropoelastin, a chemical from embryonic stem cells. (Never mind that since embryonic stem cells come from pre-implantation blastulas, pregnant women don't receive any chemicals from these cells.) The advertisement continued, stating that “the product may cause some controversy because the active ingredient is sourced from human embryonic stem cells.” I’d asked Bryn to contact the spa as well as DeCouverte, but neither responded to multiple requests to talk to a reporter.

Intrigued by tropoelastin, I went to PubMed to see who had actually studied this mysterious compound. This led me quickly to Robert Mecham of Washington University in Saint Louis, Missouri, who kindly indulged my questions.

Q: Is there evidence that tropoelastin has antiaging properties? Is there any evidence that it is responsible for 'post-conception glow'?