Spinal-Cord Injury Therapy OK'd by FDA Could Lead to Cures World's first trial to test safety of cell regeneration for paralyzed patients.

July 31, 2012 -- 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 has 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 and mice, pigs and in 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."

Buoniconti, now 45, can't forget the football injury that changed his life. He was 19 when the Citadel played East Tennessee State in October 1985.

"I remember it like yesterday; I was awake the whole time," he said

He was a 220-pound middle linebacker running up the field to tackle.

"The next thing I know, the guy was flying in the air," he recalled. "I could see him doing a cartwheel with his head on the ground and his feet in the air, the number 20 jersey in the air."

They collided at just the right angle, hitting Buoniconti's head. He suffered a dislocation of the C-3, 4 vertebrae, rendering him a quadriplegic.

In his long recovery, he was told he would never walk again and Buoniconti had to learn how to breathe without a ventilator and use a breath-controlled wheelchair.

Nick Buoniconti, 71, turned his son's tragedy into action and, with his neurosurgeon, founded The Miami Project, which is devoted only to scientific research and clinical trials for a cure for spinal-cord injuries. Marc Buoniconti now serves as its president.

Promise for a Cure for Paralysis

"My family made a promise to Marc and all those living with paralysis that nothing will stand in the way of us finding a cure, absolutely nothing," Nick Buoniconti said in a prepared statement today. "FDA approval of this clinical trial is allowing us to follow through on this incredibly important commitment that impacts millions of families each day."

Marc Buoniconti headed to the University of Miami to study psychology, graduating in 1993. He jokes that, "I got my Ph.D. in hard knocks."

Since then, he has been a tireless advocate for the disabled, sitting on a number of corporate boards and working for legislation to decrease car crashes, the primary cause of spinal-cord injuries.

He tries to stay in shape, especially for the day when the cure for which he has worked so hard comes.

"Always in the back of my mind, I am an athlete," Buoniconti said. "And have to prepare for the future."