First Schwann Cell Transplant for SCI – the trials begin!
Doctors at The Miami Project to Cure Paralysis, at the University of Miami Miller School of Medicine, performed the first-ever FDA approved Schwann cell transplantation in a patient with a new SCI. Schwann cells wraps around the nerve fiber in the peripheral nervous system, and form the myelin sheaths of peripheral axons. The procedure is a Phase 1 clinical trial designed to evaluate the safety and feasibility of transplanting the patient’s own Schwann cells.
“This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. This trial, and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said neurosurgeon Barth Green, M.D., Chair of The Miami Project, and Professor and Chair of Neurological Surgery.
The transplantation procedure was conducted by the Principal Investigators of the trial, Drs. Allan Levi, M.D., Ph.D., Professor of Neurological Surgery, Orthopedics, and Rehabilitation, and James Guest, M.D., Ph.D., Associate Professor of Neurological Surgery. The patient had a neurologically complete thoracic spinal injury and received the transplantation of autologous Schwann cells about four weeks post-injury. There have been no adverse events and the team is moving forward with the trial.
The trial will enroll a total of eight participants with acute thoracic SCI. They will undergo a biopsy of a sensory nerve in one leg to obtain the tissue from which to grow their own Schwann cells. The Schwann cells are then grown in a state-of-the art culturing facility for three to five weeks to generate the number of cells necessary for transplantation, and to undergo the strict purification process. By the time the Schwann cells are surgically transplanted into the injury site, participants will be 26-42 days post-injury.
Each participant will be followed intensively for one year after receiving the transplantation surgery, and their neurologic status, medical status, pain symptoms, and muscle spasticity will be evaluated. It is expected that it could be two to three years from the time the first subject is enrolled until the final subject is one year post-transplantation. All participants will continue to be monitored for an additional four years under a separate clinical protocol.
The entire news release is here: