Briefly, the study will involve transplanting tissues derived from human embryonic stem cells into patients who have recently suffered severe spinal cord injury. The principle behind the study is that the embryo-derived oligodendrocytes might repair myelin and restore the ability for nerves to transmit impulses. According to the Nature report, Geron, submitted 22,000 pages of material to FDA, including data from 24 studies involving over 2000 animals.
So is the decision to initiate studies at this juncture prudent? That's impossible to know without seeing the supporting data. What I can comment on, however, is the recurrence of a rhetoric that glosses trial initiation– rather than trial outcome– as a medical achievement in itself. Whereas the former is a regulatory event, the latter is a clinical event. In my book about gene transfer, I argue that this sets up a cycle of expectation that is difficult to sustain given the scientific and clinical uncertainties. We saw this in the early days of gene transfer. Some examples of this "trial initiation"="medical achievement":
• "This... marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing." (Thomas Okarma, Geron chief executive)
• "Today's news... is a milestone in the new era of hope..." (Amy Comstock Rick, Coalition for the Advancement of Medical Research)
• "This is what we've all been waiting for" (Robert Lanza, Advanced Cell Technology)
• "The announcement boosted the price of shares in [Geron]... up 56% from the day before the announcement" (Meridith Wadman, Nature, Jan 27, 2009)
I wish Geron, and the patients enrolled in this study, all the best. But if embryonic stem cell work is anything like practically every other major medical advancement, be prepared for a very long, tough slog with lots of setbacks. In one of the stories, Sean Tipton from the Coalition for the Advancement of Medical Research, commented "This is a trial of one particular application, not a trial of all embryonic stem cells." That sounds just about right. (photo credit: no typographic man, UlamSpiral (negative), 2006)