Last week, the U.S. Food and Drug Administration granted permission to the Miami Project to Cure Paralysis to begin a Phase 1 clinical trial to test the use of human Schwann cells in curing paralysis. Schwann cells are found in the peripheral nervous system and they are basically the nervous system’s means of communication. The cells send electrical signals throughout the nervous system, and when they are damaged by an injury, paralysis can occur. Thus, Miami Project physicians and researchers believe that Schwann cells can tell them everything they need to know about finally developing a cure to paralysis.
According to a statement from the foundation, the first step in the earliest stage of this one-of-a-kind trial is to transplant the Schwann cells of a patient at his or her site of injury. This will reveal to the physicians whether or not this trial will be safe to advance.
“We believe today’s announcement is just as important to our field as man’s first step on the moon was to the space program,” said neurosurgeon Barth Green, M.D., Co-Founder and Chairman of The Miami Project. “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. Today the scientists, clinicians, and technicians who have made this day possible have taken a giant leap forward. The hundreds of millions of dollars and incalculable hours of bench and clinical work invested in this goal have been well spent.”
The Miami Project was founded by Dr. Green and former NFL player Nick Buoniconti, whose son Marc suffered a spinal cord injury while playing college football at the Citadel in 1985 and has been paralyzed ever since. The organization’s success thrives on the efforts of more than 250 scientists and researchers, as well as the determination of the Buoniconti family in helping Marc – and many others – walk again.
“Back in 1985, all we had was Dr. Green’s dream, my family’s determination, a lot of hope, and a ton of hard work ahead of us,” said Miami Project President Marc Buoniconti. “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.”
Phase 1 will begin with 8 patients undergoing a series of tests to see if they’re qualified to advance in the procedures. Doctors will remove Schwann cells from a patient’s leg and cultivate them for up to 5 weeks. Once the proper number of cells have been cultivated, they will be transplanted into each patient’s site of spinal injury. Dr. Green and his team hope that will open the door to the next step of the trial and bring them the closest that anyone has ever been to curing severe spinal cord injuries and paralysis.