By next month, new research on human patients will begin at the Miami Project to Cure Paralysis _ the only trial of its kind in the world.
“The FDA has approved the Miami Project to conduct a human clinical trial for Schwann cell transplantation in individuals with spinal cord injury,” said Marc Buoniconti.
The Miami Project was started 26 years ago when Buoniconti was paralyzed in a football game.
“Every great journey starts with a first step. We're here today to celebrate that first step,” said Nick Buoniconti, Marc' father.
After his son’s injury, he co-founded the Miami Project at the University of Miami with Dr. Barth Green.
For the study, a piece of a peripheral nerve which has Schwann cells will be taken from the patient and used to generate millions of these cells. Three to five weeks later they will be injected into the injured area of the spinal cord.
“Then they mylenate they re-insulate the damaged fibers. The schwann cells also make the injured spinal cord more permissive for regeneration. So these cells can also wake neurons up and get them to grow,” said Dalton Dietrich, Miami Project scientific director.
Mary Bartlett-Bunge, who is leading this research, said these are not stem cells.
"The fact that we can use a person's own cells is extremely important and that's been one of the most important factors that drive our research," she said.
In this phase one , FDA study researchers will only be testing safety in eight newly injured patients.The cells must be transplanted 26 to 40 days after injury.
“We are looking for patients between the ages of 18 and 50 who have sustained a thoracic spinal cord injury with complete paralysis in the legs and loss of sensation in the legs, said " UM neurosurgeon Dr. Allen Levi, the study's principal investigator.
Alex Tommasino was paralyzed 13 years ago.
“This is why i still go to physical therapy once a week for, and I try to stay as active as possible for this day, so it's very emotional and exciting," he said.
The potential for this therapy goes beyond spinal cord injury, according to Green.
"There are tens of millions of people out there who have brain injuries and other neurological degenerative diseases and all of these people potentially can benefit from this ability to repair the central nervous system," he said.
If this study shows schwann cell therapy is safe in the newly injured, UM will immediately apply to the FDA to begin trying it in people who have been paralyzed longer.
“I've been here 29 years. I want to get up already. I have a lot of dancing to do, “ said Luis Hernandez.