The US Food and Drug Administration (FDA) has reportedly submitted approval for The Miami Project to Cure Paralysis, of the Miami, Fla-based University of Miami Miller School of Medicine, to move forward with its Phase 1 clinical trial to assess the safety of transplanting human Schwann cells to treat recent spinal cord injury (SCI) patients. “When we started The Miami Project, the short-term goal was to improve the quality of life of people living with paralysis, but the long-term goal remains re-establishing function and finding a cure,” Barth Green, MD, neurosurgeon, The Miami Project co-founder and chair, explains.
The Miami Project president, Marc Buoniconti, adds, “To be at this point today, receiving FDA authorization for this Schwann cell trial, is so rewarding to me, my family, and everyone who has ever stood by our side and supported this important work. This is another of the many monumental steps we’ve undertaken these past 26 years that will lead us to our ultimate goal of curing paralysis.”
According to a recent news release, the clinical trial will enroll eight participants with an acute thoracic SCI. The newly injured patients will be required to meet stringent criteria and agree to participate in further screening 5 days following injury. Researchers report that they will perform biopsy of a sensory nerve in one leg in order to obtain the patient’s Schwann cells, which will then be grown in a culturing facility for 3 weeks to 5 weeks in order to purify them and generate the number of cells necessary for transplantation. At 26 days to 40 days post-injury, the news release notes that the Schwann cells will be surgically implanted into the injury site.
Researchers add that the procedures will be conducted in Miami at University of Miami Hospital, Jackson Memorial Hospital, and The Miami Project to Cure Paralysis. For more information, visit www.miami.edu
Source: University of Miami Miller School of Medicine