FDA Approves First Trial for Therapy Derived From Human Embryonic Stem Cells
Andrew Pollack at The New York Times reports that biotech company Geron has won approval for its Phase I trial of a hESC-derived therapy, which will treat spinal cord injuries:
Geron’s trial will involve 8 to 10 people with severe spinal cord injuries. The cells will be injected into the spinal cord at the injury site 7 to 14 days after the injury occurs, because there is evidence the therapy will not work for much older injuries. …Geron’s therapy involves using various growth factors to turn embryonic stem cells into precursors of neural support cells called oligodendrocytes, which are then injected into the spinal cord at the site of the injury.
He is careful to note that this is still a very early stage in the process, and that it could be years before the therapy, if successful, could be widely available. Geron officials quoted express tempered expectations, emphasizing that the trial will focus on safety.
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