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MIAMI (CBSMiami) – The Miami Project to Cure Paralysis has taken their first step in a clinical trial involving the transfer of Schwann cells to assist in the healing of a spinal cord injury.
Led by Miami Project Scientific Director Dr. Dalton Dietrich, the Schwann cell clinical trial team performed the first ever FDA approved Schwann cell transplantation in an individual with a new spinal cord injury.
“This historic clinical trial represents a giant step forward in a field of medicine where each tangible step has tremendous value. The trial and these first patients in this trial specifically, are extremely important to our mission of curing paralysis,” said Dr. Barth Green, neurosurgeon and Co-Founder and Chairman of The Miami Project.
The transplantation procedure was conducted by Drs. Allan Levi and Jim Guest at the University of Miami/Jackson Memorial Medical Center. The participant received the transplant approximately four weeks after their injury. So far there have been no adverse events and the team is moving forward with the trial.
The Phase 1 clinical trial was designed to evaluate the safety and feasibility of transplanting the patient’s own Schwann cells.
The Miami Project clinical trial will enroll a total of eight participants with acute thoracic spinal cord injuries.
“This trial, when completed successfully, will lay the critical foundation for future cell-based therapies to target spinal cord injuries,” said Dr. Dietrich.
The Miami Project plans to use this Phase I trial as the foundation to develop future cell transplant trials targeting different types of injuries, times post-injury, and therapeutic combinations.