Stem Cells Update: Clinical Trials, Possible Funds, Long-Range Visions and Short-Term Scams

Posted by Pete Shanks September 29, 2011
Biopolitical Times
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Embryonic stem cells (ESCs) are edging back into the spotlight as possible therapies, along with other kinds of cell reprocessing. Some of the news is definitely hopeful, if as yet tentative and very small-scale. Beyond that, there appear to be schemes, visions, some government money and some possible scams, and it's sometimes a little hard to tell what's real and what's a sales job.

Both Geron and Advanced Cell Technology (ACT) are slightly expanding their small safety trials of ESC-based therapies. Geron has added a fourth patient, who was treated at Stanford this month; he has a recent, severe spinal cord injury and the hope is that injected cells will replace damaged neurons in his spine. ACT is running safety trials in the US to treat two different forms of macular degeneration, each with one patient so far; they have just received approval in the UK to replicate one trial and are applying for permission to perform the other. Both companies say they are optimistic so far, but emphasize that these are very early days.

There are also intriguing reports of cell-based gene therapies for HIV/AIDS, some of which may develop into stem-cell-based treatments. This is an area with more than its share of disappointments, so it is important not to overplay early reports. The best result came in just one patient, and this may not be a practical treatment on a large scale, but it's certainly a hopeful indication and an interesting piece of science.

Meanwhile, President Lee Myung-bak of South Korea has just signaled a policy shift back to the view that stem cell research could be a "core new growth engine" for their economy. He admitted that a few years ago there was "a disappointing incident" (the Hwang Woo-suk scandal) but announced a national stem-cell bank, a number of regulatory reforms, and about $90 million in new investment next year. Scotland is investing also, to the tune of some $7.5 million, and stem cell banking is becoming a multinational industry.

Potentially the largest investments could come from the California Institute for Regenerative Medicine (CIRM), which is setting up a $30 million program catering specifically to the biotech industry according to David Jensen's California Stem Cell Report. That could be a lifeline for companies such as the long-established StemCells, Inc., founded by Irving Weissman and others, which seems to be reduced to selling assets just to raise the cash to keep going, until it can move into clinical trials. And in the medium term, CIRM is suspected to be hoping for enough visible successes that it can go back to the voters for even more funding, though that seems like a long shot.

Meanwhile, the irrepressible George Church is envisaging using reprogrammed IPS cells to make synthetic bone marrow "which is going to work much better than the diseased bone marrow" and possibly make people "more well than before they got sick." How soon? "Years, not decades." And then he sees this becoming preventive medicine:

I expect somebody who is truly brave, who has nothing wrong with them other than maybe the usual aging, saying: "I want a bone marrow transplant," or intestinal, or whatever. And it will gain momentum from there.

Initially, he admits, this will be for the rich. Some of whom are already spending money on stem cell treatments — involving adult, not embryonic stem cells -that have not come close to FDA approval. Some are sports stars: Peyton Manning traveled to Europe (reportedly with neither success nor harm) and Terrell Owens to South Korea. And at least one patient is running for President.

Governor Rick Perry had stem cells derived from his own fat injected into his back. The operation was performed by the Texas branch of the South Korean company RNL Bio (notorious for unapproved treatments, dog cloning and dubious cosmetic ventures). George Daley, of the Harvard Stem Cell Institute, was scathing:

As a highly influential person of power, Perry's actions have the unfortunate potential to push desperate patients into the clinics of quacks [who are selling unproven treatments] for everything from Alzheimer's to autism. ... I would never in a million years accept for one of my family members to undergo this.

Previously on Biopolitical Times: