The Miami Project Successfully Completes Schwann Cell Transplantation Safety Trial
The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, has published the findings of its first Food and Drug Administration-approved Phase I clinical trial involving the use of human nerve cells to repair a damaged spinal cord.
The cells, known as Schwann cells, are essential for the repair of nerve damage, and have long been thought capable of promoting recovery after spinal cord injury. The trial, performed at University of Miami/Jackson Memorial Hospital, is the first in a series designed to evaluate the safety and feasibility of transplanting autologous human Schwann cells to treat individuals with spinal cord injuries.
An article detailing the findings, “Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury,” was published in the February issue of the Journal of Neurotrauma, with Kim D. Anderson Ph.D., research associate professor in the Department of Neurological Surgery and The Miami Project, as lead author.
The trial enrolled subjects with the least chance of natural recovery in order to first establish the safety of the cell transplant procedure; specifically, it targeted people with new SCI, less than 30 days after injury, having sustained a trauma-induced lesion between thoracic levels T3-T11 and who were neurologically complete. Dose-escalation treatment tested three different doses: 5 million, 10 million, and 15 million Schwann cells. A total of 39 people were screened for eligibility, 9 were enrolled, and 6 participants were transplanted.
Schwann cells, which reside in peripheral nerves, are obtained from a nerve biopsy from each participant, so there is reduced concern of immune rejection, and immunosuppressant medication is not required. Demonstrating the feasibility of a program involving an autologous cell therapy is critical, given the reduced risk associated with autologous versus allogeneic “off-the-shelf” cell products.
Each participant was followed intensively for one year after receiving the transplantation surgery, and their neurologic status, medical status, pain symptoms, and muscle spasticity were evaluated. All participants will continue to be monitored for a total of five years after the transplantation.