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The Miami Project announced today that the first of 8 patients with acute spinal cord injury (up to 42 days post-injury) has been enrolled in a long-awaited trial of Schwann cells. Here's the press release
This is a Phase I trial, meaning that it's really only looking at safety. Any recovery would be a bonus, and a surprise. The Schwann cells, derived from each patient (the term is autologous, these from nerve cells in the leg), are cultivated and expanded, then injected at the site of injury. In animal experiments, the cells provide a supportive environment within the lesion area, allowing some spinal cord nerves to grow into what is otherwise a hostile environment.
The trick for getting function back is getting spinal axons to grow beyond the injury site. Schwann cells alone can't do that; other combinations of molecules, or cells, will have to be added. The scientists at the Miami Project know this but can't, by FDA rules, do combination therapies. So first, proof that Schwann cells are safe will allow the work to continue toward meaningful therapies.
"A giant step forward," said neurosurgeon Barth Green, M.D., MP Co-Founder. Kudos to the team there for moving this along.