University of Miami Miller School of Medicine researchers led a unique and groundbreaking randomized controlled trial showing umbilical-cord-derived mesenchymal stem cell infusions safely reduce risk of death and quicken time to recovery for the severest COVID-19 patients, according to results published online on January 5, 2021 in STEM CELLS Translational Medicine. The open-access article is titled “Umbilical Cord Mesenchymal Stem Cells for COVID‐19 Acute Respiratory Distress Syndrome: A Double‐Blind, Phase 1/2a, Randomized Controlled Trial.” The study's senior author, Camillo Ricordi, MD, Director of the Diabetes Research Institute (DRI) and Cell Transplant Center at the University of Miami Miller School of Medicine, said treating COVID-19 with mesenchymal stem cells (image) makes sense. The paper describes findings from 24 patients hospitalized at University of Miami Tower or Jackson Memorial Hospital with COVID-19 who developed severe acute respiratory distress syndrome. Each received two infusions, given days apart, of either mesenchymal stem cells or placebo. "It was a double-blind study. Doctors and patients didn't know what was infused," Dr. Ricordi said. "Two infusions of 100 million stem cells were delivered within three days, for a total of 200 million cells in each subject in the treatment group." Researchers found the treatment was safe, with no infusion-related serious adverse events. Patient survival at one month was 91% in the stem-cell-treated group versus 42% in the control group. Among patients younger than 85 years old, 100% of those treated with mesenchymal stem cells survived at one month. Dr. Ricordi and colleagues also found time to recovery was faster among those in the treatment arm.
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