Miami Project Schwann Cell FDA Approval

posted on August 2nd, 2012 in Festivals & Conferences by rodrigo. Credits: Rodrigo Gaya

Donna Shalala, Barth Green, Marc Buoniconti, Nick Buoniconti, & Lois Pope

Miami, FL – July 31, 2012 - The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, has received permission from the Food and Drug Administration to begin a revolutionary Phase 1 clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries.

Found mainly in the peripheral nervous system, Schwann cells are essential to sending appropriate electrical signals through the nervous system, and Miami Project scientists and supporters believe they are key to finding cures for paralysis. In what will be the only FDA-approved cell therapy-based clinical trial for sub-acute spinal cord injury in the United States, investigators plan to transplant a patient’s own Schwann cells at the injury site in the hope of ascertaining safety that will allow further trials to proceed designed to evaluate efficacy.

“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.”

Nick Buoniconti, Co-Founder of The Miami Project, said, “It has been 26 years since 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. FDA approval of this clinical trial is allowing us to follow through on this incredibly important commitment that impacts millions of families each day. This validation of the tireless efforts being undertaken at The Miami Project offers real hope and shows we are closer than ever to curing paralysis.”

Barth Green, Marc Buoniconti, & Nick Buoniconti

Donna Shalala & Nick Buoniconti

Dalton Dietrich, Nick Buoniconti, Barth Green, Marc Buoniconti, Terry Buoniconti, Damien Pearse, Mary Bartlett Bunge, Donna Shalala, Allan Levi, Lois Pope, & James Guest