An international team of scientists led by Camillo Ricordi, M.D., director of the Diabetes Research Institute and Cell Transplant Center at the University of Miami Miller School of Medicine, has been given FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells to hinder the life-threatening lung inflammation of severe COVID-19 cases.
Dr. Ricordi says there is no time to waste as patients who die from COVID-19 have a median time of just 10 days between their first symptoms and death. He adds that 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 is the result of a cooperative academic initiative sponsored by The Cure Alliance. In response to the COVID-19 pandemic, The Cure Alliance has pivoted all resources to fight the virus. The clinical protocol has been shared with other academic institutions throughout the world who want to test similar treatment strategies in the fastest and most efficient way possible.
The FDA had formerly authorized the testing of umbilical cord-derived mesenchymal stem cell products in patients with type 1 diabetes and Alzheimer’s disease at the University of Miami as part of other clinical trials.
For the COVID-19 trial, Dr. Ricordi recruited additional international experts with broad knowledge in infectious diseases, pulmonary medicine, and critical care, while others gave expertise in cell-based product development and their use in clinical trials.