Clearance Received by the FDA for Schwann Cell Clinical Trial
October 2014 – The Miami Project to Cure Paralysis, at the University of Miami Miller School of Medicine has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase I clinical trial to evaluate the safety of autologous human Schwann cell transplantation in the chronic spinal cord injury (SCI) setting.
The clinical protocol of the Phase I trial is focused on safety and feasibility outcomes. The investigative team is already conducting a Phase I trial assessing safety of autologous Schwann cell transplantation in individuals with subacute SCI. The new trial will be conducted in parallel and focus on individuals with chronic SCI. Individuals that are at least 1 year post-injury will have to meet the inclusion/exclusion criteria and agree to participate in the trial, which initially will require approximately 10 months of their time. Participants will be monitored long-term for a total of five years. Each participant’s own Schwann cells will be obtained from a sural nerve biopsy. The Schwann cells will then need to be derived from the nerve and processed in a culturing facility to generate the number of cells necessary for transplantation, and to undergo a purification process. The cell therapy will be combined with an intense exercise and rehabilitation intervention to maximize outcome.
Led by W. Dalton Dietrich, Ph.D., Scientific Director, The Miami Project to Cure Paralysis, the Schwann cell clinical trial team is comprised of a multi-disciplinary group of faculty level scientists, neurosurgeons, and staff focused on advancing the trial.
“This clearance by the FDA to move forward into chronic injury is a vital step for the field of SCI research, and for The Miami Project team that has been working diligently for more than a quarter of a century to get us to this point. This trial, along with the ongoing subacute trial, will provide another piece of the critical foundation we are building for future cellular therapies and combinations we plan to target SCI,” said Dr. Dietrich.
All procedures will be conducted in Miami at the University of Miami Miller School of Medicine. Institutional Review Board (IRB) review and approval must be obtained prior to beginning any part of the trial. Screening will likely begin in early 2015.
Because the Schwann cells, which are found in the peripheral nerves, are obtained from a nerve biopsy from the participant, there is reduced concern of immune rejection and immunosuppressant medication is not required. Once the cells are removed from the participant, they have to be handled in accordance to current Good Manufacturing Practices (GMP). Because the cells will eventually be injected into the spinal cord, this process is required to ensure that the cells are prepared consistently and without contaminants.
SCIENCE/TRIAL CONTACT: Kim Anderson, Ph.D., 305-243-7108 or mpinfo@med.miami.edu