At the Lois Pope LIFE Center, an affiliate of the University of Miami Miller School of Medicine, the Miami Project to Cure Paralysis has recently taken a step forward. The Project gained approval from the U.S. Food and Drug Administration to move forward with Phase 1 trials in human subjects for an innovative treatment for patients with recent spinal cord injuries. Established in 1996, the LIFE Center was made possible through a $10 million gift provided by Lois Pope with the aim of supporting research that would eventually allow spinal cord injuries to be reversed. Thanks to new innovations that utilize Schwann cells, which are involved in electric signal messaging in the nervous system, the Miami Project’s team at the LIFE Center hopes to take the first steps toward fulfilling its mission and ending paralysis.
During the first FDA-approved trial in the United States that will investigate the use of cell therapy-based treatments for sub-acute spinal cord injuries, the LIFE Center’s researchers plan to work with eight participants suffering from acute thoracic spinal cord injuries. These patients will undergo sensory nerve biopsy to obtain Schwann cells that will be used to seed new cell growth at a culturing facility, allowing the researchers to create enough cells to transplant into the site of injury. In this Phase 1 trial, scientists will be primarily concerned with establishing that the procedure is safe for use in humans, with post-operative monitoring continuing for years in the future.