Spinal-Cord Injuries: FDA Approves Cell-Regeneration Therapy
(NEW YORK) -- Marc Buoniconti has been paralyzed from the neck down for 27 years after a college football injury at South Carolina's The Citadel.
His Hall of Fame linebacker father, Nick Buoniconti, triumphed on the football field as a Boston Patriot and Miami Dolphin, but finding a cure for his son's paralysis has been the toughest game of all, until now.
Father and son have seen the fruits of their joint venture -- the Miami Project Cure Paralysis -- to help the 300,000 Americans living with spinal-cord injuries.
The Food and Drug Administration on Tuesday approved a phase 1 clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with paralysis. It is the first such trial in the world.
Researchers believe these cells, which are found in the peripheral nervous system and are responsible for sending electrical signals, might be the key to eventual cures.
"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 Dr. Barth Green, co-founder and chairman of The Miami Project.
Eight patients with acute spinal-cord injuries, or those within one month of paralysis, will be injected with their own Schwann cells as scientists at the University of Miami Medical Center monitor them for side effects.
"I am more optimistic now than I have ever been before," Marc Buoniconti said.
"You see decades of work and scientists have given their lives to neuroscience," he said. "You see donors and friends giving millions of dollars for years, wanting to see results. ... It will be the culmination of hopes and dreams turned to reality."
Although this first effort at cell-replacement therapy is only a safety trial, Miami Center researchers hope the Schwann cells, which behave like stem cells, will eventually restore function and sensation.
They have already successfully repaired central nervous system injuries in lab animals by transplanting their own Schwann cells to the site of the injury, where they reinsulate damaged nerve cells.
In studies done in rats, mice, pigs and primates, about 70 percent of function and movement was restored to the fully paralyzed animals.
"Not only do [the Schwann cells] survive, they grow and remyelinate, with no toxicity or tumors," Buoniconti said. "This is a huge stepping stone."
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