Dr. Camilo Ricordi, director of the Diabetes Research Institute (DRI) and Cell Transplant Center at the University of Miami Miller School of Medicine, and his team of international collaborators are reporting the results of a groundbreaking randomized controlled trial showing umbilical cord-derived mesenchymal stem cell (UC-MSC) infusions safely reduce risk of death and quicken time to recovery for the most severe COVID-19 patients, reported The Cure Alliance.
Dr. Ricordi’s peer-reviewed paper has just been published in STEM CELLS Translational Medicine (SCTM). The clinical trial, authorized by the U.S. Food and Drug Administration (FDA) last April, was initiated by The Cure Alliance, non-profit organization founded ten years ago by Dr. Ricordi for scientists around the world to share knowledge and accelerate cures of all diseases.
At the start of the pandemic, all focus pivoted to ending suffering caused by COVID-19. Dr. Ricordi created a “mini-Manhattan project,” the result of which has yielded this important new weapon in the arsenal against COVID-19, especially during this critical time when distribution of the new vaccines is slower than anticipated and the infection rate and death toll are still surging.
The SCTM 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 (SARS), a dangerous and often fatal complication marked by severe inflammation and fluid buildup in the lungs. Each patient received two infusions of either mesenchymal stem cells or a placebo, given days apart.
At one month, 100percent of patients (<85) who received the UC-MSC infusions survived versus 42 percent in the control group. Researchers found the treatment was safe, with no infusion-related serious adverse events.
Dr. Ricordi’s team also reports recovery time was faster. More than half of patients treated with the UC-MSC infusions recovered and went home from the hospital within two weeks. More than 80 percent of the treatment group recovered by day 30, versus less than 37 percent in the control group.
“It’s like smart bomb technology in the lungs to restore normal immune response and reverse life-threatening complications,” Dr. Ricordi said.
Just one umbilical cord, donated from a caesarean section, can yield up to 10,000 doses of the COVID-19 treatment.
“Our results confirm the powerful anti-inflammatory, immunomodulatory effect of UC-MSCs. These cells have clearly inhibited the ‘cytokine storm’, a hallmark of severe COVID-19,” said Giacomo Lanzoni, Ph.D, lead author of the SCTM paper.
“The results are critically important not only for COVID-19 but also for other diseases characterized by aberrant and hyper-inflammatory immune responses, such as autoimmune Type 1 Diabetes. We are very much looking forward to applying these cells in clinical trials to halt the progression of Type 1 Diabetes,” he added Dr. Lanzoni is Research Assistant Professor, Diabetes Research Institute, Department of Biochemistry and Molecular Biology at the University of Miami Miller School of Medicine.
Dr. Ricordi’s core team included scientists with expertise in stem cells, pulmonary disease and critical care, but it was the diabetes researchers who began to crack the code. At the DRI, Dr. Ricordi and his colleagues had been collaborating with Chinese scientists to study UC-MSCs for the treatment of diabetes Type 1. With the outbreak of the pandemic, he learned those collaborators were now testing the treatment in severely ill COVID-19 patients and reporting success. The researchers in China were soon joined by Israeli researchers, reporting as many as 100percent of treated patients surviving and recovering faster than those without stem cell treatment. But none of the studies was a randomized trial, the gold standard in science.
The potential for the treatment was certainly promising. Mesenchymal cells are known to help correct immune and inflammatory responses that go awry. They also have antimicrobial activity and have been shown to promote tissue regeneration.
When given intravenously mesenchymal stem cells migrate naturally to the lungs, exactly where therapy is needed in COVID-19 patients with life-threatening acute respiratory distress syndrome.
Dr. Ricordi enlisted Dr. Lanzoni and several key collaborators at the Miller School, the University of Miami Health System, Jackson Health System, plus others internationally and across the U.S., including Arnold I. Caplan, Ph.D., of Case Western Reserve University, the first scientist to identify mesenchymal stem cells.
A larger clinical trial is underway. Until it is approved by the FDA for wide use, the UC-MSC treatment will be made available to medical centers for compassionate use cases.
