Tuesday, November 17, 2009
Human Trails to Begin Using High Purity Stem Cells
Pending one final review, next year a handful of paralyzed men and women are set to get Keirstead's high-purity stem cells injected directly into their spinal cords, above and below the injury site. Conducted by the Geron Corporation — to whom Keirstead turned over his research — it will be the first-ever test of purified stem cells in humans. Again, the public is mesmerized by what could happen, and again, Keirstead's colleagues are nervous. If the phase-one trial exacerbates a subject's condition or, far worse, kills one, Keirstead's test won't just fail, it could retard progress on stem cells for decades. He is in effect taking the first major step on stem cells for everyone. And he's doing it with a novel therapy that has a shorter paper trail than most.
Aware of the stakes, the FDA temporarily put the brakes on the trial in August, weeks before it was originally set to begin, so it could rereview the data. But Keirstead is unfazed. He has confidence in his work. The trial application Geron submitted was the longest ever — twenty-two thousand pages — all pointing toward the success and efficacy of Keirstead's method. He feels certain the trial will go forward. "My guess is that the FDA got new supporting data that is very interesting and they just need time to vet it."