Safety Trial of Schwann Cell Transplantation in Subacute Spinal Cord Injury Completed Successfully
We announced in March 2017 published results of our FDA-approved Phase I clinical trial involving Schwann cell transplantation after a sub-acute spinal cord injury (SCI). The trial, performed at University of Miami Miller School of Medicine in Miami, 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.
The results, recently published in the peer-reviewed Journal of Neurotrauma, provide preliminary evidence of safety in the six subjects followed out to one year post-transplanted.
- There were no surgical, medical, or neurological complications to indicate that the timing or procedure for the cell transplantation were unsafe.
- There were no negative events related to the Schwann cell therapy.
- There was no evidence of additional spinal cord damage, tumor, or syrinx formation.
- There were minor sensory changes, including one subject converting to neurologically incomplete status.
Importantly, the trial successfully determined safety and feasibility for performing a peripheral nerve harvest within 5-30 days of injury followed by an intra-spinal transplantation of autologous cells within 4-7 weeks of injury, even in individuals having sustained severe spinal injury.
This first trial, using cells grown from the subject’s own nerves is an important validation of decades of prior work and animal studies. It is a key milestone for The Miami Project’s integrated program that studies spinal cord injury from multiple perspectives. Having now established the safety of Schwann cell transplantation in this initial group of subjects, it will be possible to combine other exciting therapies to amplify neurological recovery.
View Video Presentation by Dr. Kim Anderson