FDA Approves Cell Transplant Research on Spinal Cord Patients

The FDA has given approval to the Miami Project to Cure Paralysis to start groundbreaking clinical trials studying the effects of human cell transplants on people with spinal cord injuries.

The center’s leading researchers believe that this is a first step toward curing paralysis and may lead to medical advancements that could someday treat neurological conditions such as Alzheimer’s or Parkinson’s disease.

“We feel like this is our Olympic moment. We feel like we have won the gold,” said W. Dalton Dietrich, the center’s scientific director.

Schwann cells, found in the peripheral nervous system and essential for sending electrical signals, will be taken from recently injured patients, grown in culture for several weeks, then surgically transplanted into the participants’ spinal cords. The center’s team thinks the cells may reinsulate the damaged spinal nerves.

Researchers said the stage one trial must focus on demonstrating safety and will not reverse paralysis. Preliminary studies on several animal species were required for FDA approval on human subjects, a process that took years and a 1,500-page application.

The Miami Project to Cure Paralysis center, based at the University of Miami Miller School of Medicine, will begin recruiting eight patients as soon as the trial is approved by the university’s Institutional Review Boards.

Subjects must have suffered thoracic spinal cord injuries within five days of agreeing to participate, be between 18 and 50 years old, and have a specific level of paralysis.

Schwann cell transplants are not the same as stem cell therapies. Schwann cells are taken from the patients’ own bodies reducing the risk of rejection.

 

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