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Jul 31, 2012

Cell Therapy Trial for Paralysis Gets FDA OK

  • The Miami Project to Cure Paralysis received permission from the FDA to begin a Phase I clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries (SCIs).

    Found mainly in the peripheral nervous system, Schwann cells are essential to sending appropriate electrical signals through the nervous system, and Miami Project scientists and supporters believe they are key to finding cures for paralysis. In what will reportedly be the only FDA-approved cell therapy-based clinical trial for sub-acute spinal cord injury in the U.S., investigators plan to transplant a patient’s own Schwann cells at the injury site in the hope of ascertaining safety that will allow further trials to proceed.

    The clinical trial will enroll eight participants with an acute thoracic SCI. Newly injured patients brought to the trauma center would have to meet the stringent criteria and agree to participate in further screening within five days of their injury. At that point, the participant will undergo a biopsy of a sensory nerve in one leg to obtain his or her own Schwann cells. The Schwann cells will then be grown in a culturing facility for three to five weeks to generate the number of cells necessary for transplantation, and to undergo the strict purification process. By the time the Schwann cells are surgically transplanted into the injury site, participants will be 26–40 days post-injury.

    All procedures will be conducted in Miami at University of Miami Hospital, Jackson Memorial Hospital, and The Miami Project to Cure Paralysis. Each participant will be followed intensely for one year after receiving the transplantation surgery, and their neurologic status, medical status, pain symptoms, and muscle spasticity will be evaluated. All participants will continue to be monitored for years under a separate clinical protocol. This Phase I trial is the foundation upon which The Miami Project will develop future trials targeting different types of injuries, times post-injury, and therapeutic combinations.

    The Miami Project is a comprehensive spinal cord injury research center and a designated Center of Excellence at the University of Miami Miller School of Medicine. The project’s Christine E. Lynn Clinical Trials Initiative takes discoveries found to be successful in laboratory studies and fast-tracks them to human studies.


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