First embryonic stem cell trial put on hold
The US Food and Drug Administration (FDA) has put the first embryonic stem cell trial on hold. Geron, the company running the clinical trial, had succeeded in differentiating embryonic stem cells into oligodendrocytes that help keep neurons alive. Geron hoped the cells would promote healing in people with recently damaged spinal cords.
In Geron’s press release they say the FDA suspended the trial pending the FDA’s review of new nonclinical animal study data Geron submitted.
Is the FDA being cautious or was their something in the clinical data that aroused concern?
Stay tuned for the next exciting chapter.
Nature News blog also discusses this.
Embryonic stem cells are trickier to use than adult stem cells at this stage of our knowledge becasue in their undifferentiated state they are effectively immortal. That is, there is no limit to the number of times they can divide, which means in the human body they can form tumours. The trick is to differentiate them first, but you have to make sure there are no undifferentiated cells lurking in your batch. Adult stem cells have already gone through at least one stage of differentiation. More details on this can be found on Australian Stem Cell Centre’s web site
Jason, GNTIS