Last August paralyzed people across the country, hoping to FINALLY see quantifiable progress in the field of spinal cord injury research (raises hand), had their hopes dashed - albeit temporarily - by the FDA. And the question, “Why?” “Why did the FDA stop megacorp Geron from beginning their highly anticipated human trials?” - which would have been the first ever FDA-approved human trials to use embryonic stem cells, is still a mystery; even 4 months after the fact.
Did something horrible happen that only Geron and the FDA know about? I want to know goddamnit.
A bit of background on the study: Like all human trials, to be taken seriously, rigorous animal testing had to first be employed to make sure the human trials would be safe. According to industry analysts, the halt most likely stemmed from Geron’s release of their “dose escalation studies, which they had to share with the FDA before the human trials could begin.
In layman’s terms for this particular situation, “dose escalation” refers to increasing the amount of embryonic stem cells that were injected into the damaged spinal cords of their test animals (which were likely monkeys and/or dogs. Don’t cry for them now; cry for me). This “injection of embryonic stem cells into the injury site” is the basis of their entire study, and shows real promise.
Did tumors begin to spontaneously grow on the spinal cords? Or even more sci-fi but not out of the question, did the cells attempt to grow another spinal cord? Who the hell knows. What we do know is that embryonic stem cells are powerful, and unfortunately for people desperately waiting for a cure like me (16 years and counting), volatile as well.
Geron is mum on the issue, but says they “will work closely with the FDA to facilitate their review of the new data and to release the clinical hold.” Hopefully it’ll take months, not years. What they’re trying to do is huge, and if they succeed in restoring movement, well let’s just Geron say will go in the history books.
More to come later on this, I’m sure.
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