FDA Green Lights Phase 1 Human Trials to Cure Spinal Cord Injury Paralysis.
In a recent story released by The Miami Project to Cure Paralysis at the University of Miami Miller School of Medicine, the University announced that it got the green light from the Food and Drug Administration (FDA) to start a ground-breaking Phase 1 human clinical trial to assess the safety of human cells transplantation to treat individuals with newly acquired spinal cord injuries. Note: At this phase they are only testing the safety of doing surgery and injecting nervous system cells into spinal cords. With this safety step complete, the FDA is expected to approve the testing of Schwann cell transplantation in humans and they can start the trial.
Schwann Cells: The Key to a Cure for Paralysis
Schwann cells or neurolemmocytes are cells that sheath neurons in the peripheral nervous system (PNS). The PNS is the portion the nervous system that is outside of the brain and spinal cord. Schwann cells are a vital component of the neuron (see Image 1) that assists in sending electrical signals to the peripheral organs and tissues. The advocates and researchers at the Miami Project believe Schwann cells are key to finding cures for paralysis. This will be the only US based FDA approved cell therapy clinical trial for sub-acute spinal cord injury. Researchers will be transplanting Schwann cells to the SCI location to determine the safety of the procedure that will allow future clinical trials to move forward.
“Obtaining clearance from the FDA to initiate this important Phase I clinical trial is a vital step for the field of SCI research, and for the Miami Project team that has been working diligently on this therapeutic concept for more than a quarter of a century. This trial, when completed successfully, will lay the critical foundation for future cell-based therapies we plan to target SCI,” said Dr. Dietrich. W. Dalton Dietrich, Ph.D., Scientific Director, is leading the Schwann cell clinical trial team at The Miami Project. The team includes various core science and clinical faculty members, scientific staff, and regulatory personnel focused on moving the trial forward.
Clinical Trial Participants
During the clinical trial 8 participants with an acute thoracic SCI will be selected to participate. An acute thoracic SCI is a spinal cord injury that occurs immediately to the thoracic region (see Image 2 or SCI anatomy webpage). Within 5 days these patients will be brought to the trauma center and must adhere to specific criteria and agree to participate in further screenings. Once admitted a sensory nerve of the leg will be biopsied to harvest the needed Schwann cells. These cells will then be multiplied in a culturing facility to produce the needed quantity over a 3 – 5 week period. The cells will be transplanted via injection at the spinal cord injury site 26 to 40 days after the injury.
All participants will be closely monitored for a year after undergoing the transplantation for neurological and medical conditions as well as pain symptoms and muscle spasticity. The total time of the clinical trial is expected to be a minimum of 2 – 3 years from the time the first patient is enlisted to the last participant is one post-surgery. Clinical trial participants will be monitored for years under a separate clinical protocol. This exciting Miami Project Phase I trial is the groundwork that will allow future trials steering new trials and research with different types of spinal cord injuries, post-injury timing (chronic), and other therapeutic combinations.
Kim Anderson, Ph.D., 305-243-7108 or firstname.lastname@example.org
SOURCE Miami Project to Cure Paralysis