UM Health System, Miami Project to Cure Paralysis get FDA approval for human Schwann cell testing

Scientists will now test on humans to help patients with spinal cord injuries

By Terrell Forney - Reporter

MIAMI - Victims of spinal cord injuries have a renewed hope of finding a cure after learning the federal government will allow scientists to use humans in paralysis research.

The Food & Drug Administration has given the green light to the University of Miami Health System where doctors work closely with the Miami Project to Cure Paralysis. The first of its kind procedure involves the use of Schwann Cells -- cells that are in every human being.

Testing on these cells have been done on animals for years, but the new FDA approval allows this type of research to be done on humans.

South Florida will serve as the only active trial in the country for this type of cell regeneration therapy.

"Elation and happiness," said Robin Cleary, as she described her feelings to Local 10's Terrell Forney. "I'm excited. It means the world to me."

Cleary has been paralyzed from the neck down for 16 years, ever since she injured her spinal cord after falling off a horse.

"I hope it means I can get out of the wheelchair," she said.

A panel of doctors and leaders from the University of Miami Health System announced the news Tuesday morning before a crowd of medical students and victims who are coping with spinal cord injuries.

Researchers like Dr. Barth Green compare the news to the medical world's version of astronauts taking the first steps on the moon.

"Today is about the people in the front row who are not able to stand up and cheer," said Green, who has spent decades working on a cure for paralysis.

Schwann cell implementation in humans is considered the most significant medical advancement in the history of the Miami Project to Cure Paralysis and in the history of spinal cord injury research.

"We did it! We are now working in humans," said Marc Buoniconti, the head of the Buoniconti Fund to Cure Paralysis.

Buoniconti was paralyzed 27 years ago after suffering a spinal cord injury while on the football field.

Hundreds of millions of dollars has been invested into the effort as well as nearly three decades of tireless efforts from a countless number of scientists.

"We know it's not the end of the road, only the beginning," Buoniconti said.

Schwann cells are not stem cells. In fact Schwann cell therapy involves the use of patients being injected with their own cells. The procedure is much less controversial then stem cell use and carries far less risk of something going wrong, such as cancerous cells formation.

Researchers are convinced the procedure lays the foundation for a promising path to permanently ending paralysis.

Eight people with spinal cord injuries will be selected to undergo experimental treatments that will last a year and a half.

The patients have not yet been selected. Scientists say they will be 'new arrivals'-- which means the subjects have not yet suffered their spinal cord injury and are still walking around.

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