Wise Young on FDA regulation
From Bringing effective treatments to people with spinal cord injury: Meet Wise | The Disruptors · · Charles River Labs
“We've applied to the U.S FDA, and they want us to redo all the animal studies because you use cells from another cord blood bank, so you have to test the particular cord blood banks that you will be using for the trial.”
On , Wise Young, Special Scientific Advisor at ACORDA THERAPEUTICS INC, spoke about FDA regulation during Bringing effective treatments to people with spinal cord injury: Meet Wise | The Disruptors on Charles River Labs.
About Wise Young
Wise Young, a neuroscientist and chairman of Mononuclear Therapeutics, has stated that a clinical trial of umbilical cord blood mononuclear cell transplants for chronic spinal cord injury is expected to finish in 2023, after which he plans to initiate a phase three trial to seek global approval of the treatment. He has said that a prior phase two trial in Kunming, China, in which 15 out of 20 patients with chronic complete spinal cord injury recovered walking after receiving cell transplants and intensive walking therapy, was considered impossible just a few years ago. Young has also noted that the U.S. FDA has requested additional animal studies using cells from specific cord blood banks before proceeding with a U.S. trial. Young has described the "666 program" — six hours of walking therapy per day, six days a week, for six months — as essential for recovery, and has stated that patients who did not exercise did not regain bladder or bowel function. He has also discussed research into umbilical cord blood exosomes, which he says cross the blood-brain barrier to stimulate neurogenesis, and has expressed interest in initiating clinical trials of lithium for neuropathic pain. Young has emphasized the need to reduce the cost of umbilical cord blood cell therapy from about $10,000 per dose to around $100 to make it accessible globally, and has said that the goal of treatment should be to make patients "better than they were before they were injured."