The Miami Project to Cure Paralysis has received the green light from the U.S. FDA to proceed with a Phase I clinical trial to evaluate the safety of autologous human Schwann cell transplantation for chronic spinal cord injuries.
The team is already conducting a similar trial subacute SCI. The new trial will be conducted in parallel and focus on individuals that are at least 1 year post-injury. Each participant’s own Schwann cells will be obtained from their sural nerve – found in the lower leg – and cultured to generate sufficient numbers. The cell therapy will be combined with an intense exercise and rehabilitation intervention to maximize outcome.