The world’s first authorized test in people of a treatment derived from human embryonic stem cells has been cleared to begin by the Food and Drug Administration.
The trial will test cells developed by Geron Corporation and the University of California, Irvine in patients with new spinal cord injuries.
The F.D.A. had initially cleared the clinical trial in January, 2009, in what was viewed at the time as a research milestone.
But before the study could begin, the agency then put a so-called hold on the trial after cysts were discovered in some mice injected with the cells. Geron had to do another mouse study and develop better ways to check the purity of its cells.
On Friday, the company announced in a press release that the F.D.A. had lifted the hold. Geron shares rose in morning trading.
Research milestone? HA! How’s this for a research milestone: Spinal cord injuries – especially complete injuries – are not reversible. There is, quite literally, “no hope” – no common therapy or drug that will ever improve your mobility or function over time. I know this from personal experience. I have been paralyzed for 11 years since I received a spinal cord injury in a car accident my junior year of high school. That is why it is simply amazing that, for a few years now, adult stem cells have been successfully used in early human trials to restore some feeling and movement in long term spinal cord injury patients (see here, here, here, here, here and here). All, as Wesley Smith points out, without the fanfare of the MSM.
Whatever happens with this new trial – if it ever happens (Geron has been promising this trial for years now) – will not change the fact that human embryonic stem cell research is unethical, period. I’d sure love to be able to walk again, but I would never accept the harvesting of another human life, no matter how small, for my own comfort.