A Phase I clinical trial that targeted individuals with new onset paraplegia to evaluate the safety of transplanting their own potentially neuroprotective Schwann cells into a trauma-induced spinal cord lesion showed no evidence of adverse effects after 1 year. This novel cell therapy approach for treating subacute thoracic spinal cord injury is described in an article in Journal of Neurotrauma, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Neurotrauma website until April 22, 2017.
Kim Anderson, PhD, Allan Levi, MD, PhD, and coauthors from University of Miami Miller School of Medicine and Bruce W. Carter Department of Veterans Affairs Medical Center (Miami, FL) describe the design and results of the clinical trial in which they harvested Schwann cells from a nerve of each paralyzed patient, cultured them in the laboratory, and then injected them directly into the site of the spinal cord lesion within 72 days of injury.
In the article entitled "Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury" the authors present the results obtained from three different doses of Schwann cells and report no negative effects related to harvesting or transplanting the cells. 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.
"From the Journal's perspective, this is an extremely important communication in the area of human traumatic spinal cord injury. Although as a Phase 1 study the sample size is small and the study is constrained by the strict inclusion/exclusion criteria mandated by the FDA, the study as performed remains an important proof of concept in the field of spinal cord injury," says John T. Povlishock, PhD, Editor-in-Chief of Journal of Neurotrauma and Professor, Medical College of Virginia Campus of Virginia Commonwealth University, Richmond. "Having established the safety of Schwann cell transplantation in this initial group of subjects, the authors, as well as others, will now be better positioned to fully evaluate this approach and possibly combine it with other nascent therapies to amplify neurological recovery."