Back in April, during the onset of pandemic in the United States, TrialSite reported that the U.S. Food and Drug Administration (FDA) has granted immediate authorization for a mesenchymal stem cell-based study led by Dr. Camillo Ricordi with University of Miami Miller School of Medicine, Jackson Health System and a group known as the Cure Alliance. The 24 participant study involved the testing of the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that can accompany severe cases of COVID-19. This same regenerative therapy has been shown to reduce the risk of death and accelerate time to recovery for the severest COVID-19 patients. The study, published in the journal Stem Cells Translational Medicine Review this month. The study results, although preliminary due to study limitations, including size, and prospect of bias, evidence a remarkable impact pointing to the rationale for larger studies. The completion of this study was funded by the North American Building Trades Unions.
The Investigational Product
The study involved the use of umbilical cord-derived mesenchymal stem cells (UC-M...
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