Schwann Cell Clinical Trial For Chronic SCI Approved by the FDA

MPThe 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.

See the full story at the Miami Project: HERE

THE PROJECT 2014 pdf file LINK

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