Special Scientific Advisor, Acorda Therapeutics
Search every verified Wise Young interview, podcast appearance, and on-the-record quote — each transcript cross-checked by AI and human review to confirm speaker identity. 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."
“I've been working on spinal cord injury now for over 40 years, and been told by almost everybody that nothing could be done.”
“The first thing we found was that you only need about 10% of the fibers in the spinal cord for an animal to recover walking.”
“We inject the cells into the normal part of the spinal cord, not the injured part. And what happens we discovered was that cells that we transplanted will migrate into the injury site and build a bridge.”
“Given that 15 out of 20 patients that we transplanted recovered walking and bowel and bladder function, many of our patients are doing their shopping and transferring from bed to wheelchair without any help.”
“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.”
“I want to use this to get ourselves into a pivotal phase three trial that will do around the world and get approval by the end of 2024 for this therapy.”
“One of the reasons why I really worked very hard for 40 years to do clinical trials was to give hope, because if we had therapies that did help some people that this would give them hope.”
“In 2021, due to the larger number of subjects, the trial will cost eight million dollars, which used to be about five million dollars for 27 patients.”
“Mononuclear Therapeutics is raising the funds for these clinical trials and we're working with the New York Blood Center to process the umbilical cord blood mononuclear cells for the clinical trials.”
“The trial will require COVID-19 vaccination of all subjects and caregivers that have daily contact with the subjects.”
“The trial should finish in 2023; at that time we will go ahead and initiate a phase three clinical trial around the world to see if we can get global approval of the treatment.”
“We have developed a business model working with the best public cord blood banks around the world, for example, New York Blood Bank, University of Colorado, and Duke Carolinas Blood Bank.”
“This method will allow us to treat up to 10 patients with one umbilical cord blood unit.”
“We discovered that umbilical cord blood plasma contains trillions of exosomes that cross the blood-brain barrier and the blood-spinal cord barrier to stimulate neurogenesis.”
“Animal studies are showing very promising results; in two years we can start clinical trials about cord blood mononuclear cell transplants to regenerate the spinal cord and exosome therapy to stimulate neurogenesis at the same time.”
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Date: November 21, 2015 Dr. Wise Young Science Medical Advisor at StemCyte Inc. He is keynote speaker at IAMICON 2015.
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