For years, Geron has bragged that “next year” it would be permitted to conduct human ESCR trials on people with newly acquired spinal cord injuries. And for years, that promise has been like the check in the mail that never comes. Finally, this summer, Geron was permitted to begin. But now, the FDA has backed off again, delaying the trials again. From the story:
Regulators are delaying a trial of an embryonic stem cell treatment for spinal cord injury, drug developer Geron Corp. said Tuesday. Geron said the Food and Drug Administration is reviewing new data from studies of the therapy, called GRNOPC1, on animals. The company plans to start testing its product on humans this summer, but that testing will be delayed during the FDA’s review. Geron said it will work with the FDA, and did not estimate how long the review will take.
Better safe than very sorry, given the risk of tumors. Indeed, I have spoken with enthusiastic ESCR proponents who are very worried that human testing is premature. In any event, once again there are no approved human trials for embryonic stem cell research as the adult sector continues its surge forward.