Human trials are ongoing for chronic spinal cord injury using adult stem cells. Now, the FDA is approving a human safety trial using patients’ own spinal cells for acute spinal cord injury—the kind of injury sought to be improved by the now defunct Geron embryonic stem cell human trial. From the press release:
The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, has received permission from the Food and Drug Administration to begin a revolutionary Phase 1 clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries. Found mainly in the peripheral nervous system, Schwann cells are essential to sending appropriate electrical signals through the nervous system, and Miami Project scientists and supporters believe they are key to finding cures for paralysis. In what will be the only FDA-approved cell therapy-based clinical trial for sub-acute spinal cord injury in the United States, investigators plan to transplant a patient’s own Schwann cells at the injury site in the hope of ascertaining safety that will allow further trials to proceed.
There is some over-the-top puffing in the press release, but this is good news. Let us hope it succeeds.