A team of scientists affiliated with The Cure Alliance was granted immediate FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that accompanies severe cases of COVID-19.
"There is no time to waste," said Dr. Camillo Ricordi, "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.
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The Cure Alliance is a non-profit group of scientists and innovators dedicated to sharing knowledge and accelerating cures for all diseases. In response to the COVID-19 pandemic, The Cure Alliance has pivoted all resources to fighting the virus. The clinical protocol has been already 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 previously authorized the testing of UC-MSC cell products in patients with Type 1 Diabetes and Alzheimer's Disease.