An international team of scientists has been granted immediate US Food and Drug Administration (FDA) authorisation for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to prevent the life-threatening lung inflammation that accompanies severe cases of COVID-19. The cell therapy will be administered to patients intravenously.
Dr Camillo Ricordi, the principal investigator, is the Stacy Joy Goodman Professor of Surgery and Director of the Diabetes Research institute (DRI) and Cell Transplant Center at the University of Miami Miller School of Medicine, US. “We are very grateful to the FDA’s Center for Biologics Evaluations and Research, Office of Tissues and Advanced Therapies for performing four rounds of reviews in a record time – one week… There is no time to waste. Patients who die from COVID-19 have a median time of just 10 days between first symptoms and death. In severe cases oxygen levels in the bloodstream drop and the inability to breathe pushes patients towards their end very quickly; any intervention that might prevent that trajectory would be highly desirable.”
The trial will be based at the University of Miami Health System and Jackson Health System in Miami. The clinical protocol has been already shared with other academic institutions throughout the world which wish to test similar treatment strategies in the fastest and most efficient way possible.
The trial is sponsored by The Cure Alliance, a non-profit group of scientists and innovators dedicated to sharing knowledge and accelerating cures for all diseases. One hundred percent of the philanthropic contributions raised by The Cure Alliance are being directed to this clinical trial and to expand manufacturing of UC-MSC products. According to the non-profit, if the clinical trial proves to be safe and effective, it will continue to direct any contribution received for this initiative to support future manufacturing and distribution of these cellular therapies.
The FDA has previously authorised the testing of UC-MSC cell products in patients with type 1 diabetes and Alzheimer’s at the University of Miami as part of other clinical trials.