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The clinical trial, authorized by the FDA last April, was initiated by The Cure Alliance, a 501(c)(3) non-profit organization of research scientists 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.
“It was a double-blind study. Neither doctors nor patients knew who received the treatment, who got the placebo,” said Dr. Ricordi, the lead investigator.
At one month,100% of patients (<85 ) who received the UC-MSC infusions survived versus 42% 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 among those in the treatment arm. More than half of patients treated with the UC-MSC infusions recovered and went home from the hospital within two weeks. More than 80% of the treatment group recovered by day 30, versus less than 37% 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 100% 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.
What’s more, 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.
Funding by The Cure Alliance was greatly enhanced by a $3 million grant from North America’s Building Trades Unions (NABTU). “North America’s Building Trades Unions has been a major supporter of the Diabetes Research Institute since 1984, when they started a campaign to fund, and build, our state-of-the-art research and treatment facility. NABTU has continued to support our work through the years, including our mesenchymal stem cell research that helped lead the way to this clinical trial,” Dr. Ricordi said.
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Other non-profit organizations funding the research include the Barilla Group and Family, The Fondazione Silvio Tronchetti Provera, the Simkins Family Foundation, the Diabetes Research Institute Foundation and The National Center for Advancing Translational Sciences.
The Cure Alliance continues to raise funds and awareness through direct donations and unique initiatives like SCRUFFY: Our Loyal Pandemic Pooches and the Good, the Bad, and the Crazy Haircuts We Gave Them by Shelley Ross, a photo/art book which hit #1 on the Amazon Best Seller chart upon its debut and is now sold around the world. The 196-page book with heartwarming color photos documents a dog’s life during the pandemic lockdowns as the virus expands across the planet in just four months. 100% of all profits are directed to COVID-19 research and will continue to help fund manufacturing and distribution of the UC-MSC treatment.
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.
Shelley Ross is president of The Cure Alliance.
Coauthors on the SCTM paper include: Giacomo Lanzoni, Ph.D., assistant research professor, DRI; Elina Linetsky, Ph.D., DRI director of quality assurance and regulatory affairs; Diego Correa, M.D., Ph.D., assistant professor (Research) Dept. of Orthopaedics and the DRI, adjunct assistant professor of biology at Case Western Reserve University; Shari Messinger Cayetano, Ph.D., associate professor of Public Health Sciences at the Miller School; Roger A. Alvarez, D.O., M.P.H., a pulmonologist with UHealth Pulmonary and Sleep Medicine; Antonio C Marttos, M.D., a UHealth general surgeon; Ana Alvarez Gil, DRI; Raffaella Poggioli, M.D., DRI; Phillip Ruiz, M.D., Ph.D., department of Surgery at the Miller School and the UHealth Anatomic Pathology department; Khemraj Hirani, M.Pharm., Ph.D., R.Ph., CCRP, CIP, RAC, M.B.A., director of regulatory affairs and quality assurance at the DRI; Crystal A. Bell, department of medicine at the Miller School; Halina Kusack, department of Medicine, Miller School; Lisa Rafkin, research assistant professor, DRI; Rodolfo Alejandro, M.D., professor of Medicine at the Miller School, co-director of the Cell Transplant Center, and director/attending physician of the Clinical Cell Transplant Program at the DRI; David Baidal, M.D., assistant professor of Medicine in the division of Endocrinology, Diabetes & Metabolism at the Miller School and member of the DRI’s Clinical Islet Transplant Program; Andrew Pastewski, M.D., Jackson Health System; Kunal Gawri, Miller School and University of Miami Health System; Dimitrios Kouroupis, postdoctoral research fellow at the Miller School; Clarissa Leñero, DRI; Alejandro M.A. Mantero, Ph.D., lead research analyst, department of Health Sciences at the Miller School; Xiaojing Wang, DRI; Luis Roque, DRI; Burlett Masters, DRI; Norma S. Kenyon, Ph.D., deputy director and the Martin Kleiman professor of Surgery, Microbiology and Immunology and Biomedical Engineering at the DRI; Enrique Ginzburg, M.D., chief of Surgery at University of Miami Hospital and Trauma Medical Director at Jackson South Community Hospital; Xiumin Xu, DRI; Jianming Tan, M.D., Ph.D., Fuzhou General Hospital, Fujian, China; Arnold I. Caplan, Ph.D., professor of Biology at Case Western Reserve University; and Marilyn Glassberg, M.D., division chief of Pulmonary Medicine, Critical Care and Sleep Medicine at the University of Arizona College of Medicine.
