UM School of Medicine Begins First Innovative Trial of Experimental Stem Cell Therapy to Reduce Deaths in Sickest COVID-19 Patients
Researchers at the University of Maryland School of Medicine (UMSOM) have begun testing an experimental stem cell therapy developed by Mesoblast Limited to treat hospitalized COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) who are on ventilators to help them breathe.
The trial, which is being conducted at the University of Maryland Medical Center (UMMC) and additional sites across the U.S, will involve a total of 300 patients randomized to receive either the drug remestemcel-L or a placebo in addition to the recommended standard of care to manage severe COVID-19 infections. The first patient in this national trial was treated at UMMC.
The research, funded by Mesoblast, an Australian regenerative medicine company, is designed to determine whether the drug reduces the risk of death within 30 days after the onset of treatment and whether it reduces the number of days from a ventilator to recovery.
"This stem cell therapy is a potential new therapy in our treatment arsenal to battle COVID-19," said Sunjay Kaushal, MD, PhD, Professor of Surgery at the University of Maryland School of Medicine and Chief of the University of Maryland Congenital Heart Disease Outreach Program." There is an urgent need to find new life-saving therapies for our sickest COVID-19 patients who are suffering from ARDS and require ventilators. We are eager to see whether remestemcel-L can reduce mortality in these patients."
Remestemcel-L is an experimental stem cell therapy developed for various inflammatory conditions, and it is believed to reduce inflammation by reducing the production of pro-inflammatory chemicals called cytokines. COVID-19 patients often become very ill from an escalated immune response, referred to as a cytokine storm, creating high levels of inflammation that can be fatal.
The trial will include other hospitals in the University of Maryland Medical System that have COVID-19 patients who meet the criteria. "As we extend the reach of this study to other UMMS hospitals, we affirm our commitment as an academic health system to explore all avenues to improve the health of the people we serve," said Mohan Suntha, MD, MBA, President and Chief Executive Officer of the University of Maryland Medical System. "Our hope is that research efforts like this and others we are pursuing in the midst of a novel coronavirus pandemic will help save lives."
Enrollment is expected to complete within three to four months, with interim analyses planned which could result in stopping the trial early if the drug appears to be working well or not working at all. Potential adverse effects of the treatment include rejection of the cells by the body and other immune system reactions.
"The University of Maryland School of Medicine continues to take the lead in researching innovative new therapies including stem cell therapies, and we are part of an urgent national mission to provide potentially lifesaving options to patients," said Dean E. Albert Reece, MD, PhD, MBA, who is also Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor, University of Maryland School of Medicine. "Our faculty are engaged in a myriad of research efforts to identify and test innovative techniques to help in the fight against this horrible pandemic."
About the University of Maryland School of Medicine
Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 45 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research.
With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $540 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System ("University of Maryland Medicine") has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community.
The School of Medicine faculty, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu
About the University of Maryland Medical Center
The University Of Maryland Medical Center (UMMC) is comprised of two hospital campuses in Baltimore: the 800-bed flagship institution of the 14-hospital University of Maryland Medical System (UMMS) — and the 200-bed UMMC Midtown Campus, both academic medical centers training physicians and health professionals and pursuing research and innovation to improve health. UMMC's downtown campus is a national and regional referral center for trauma, cancer care, neurosciences, advanced cardiovascular care, women's and children's health, and has one of the largest solid organ transplant programs in the country. All physicians on staff at the downtown campus are clinical faculty physicians of the University of Maryland School of Medicine. The UMMC Midtown Campus medical staff is predominately faculty physicians specializing in diabetes, chronic diseases, behavioral health, long term acute care and an array of outpatient primary care and specialty services. UMMC Midtown has been a teaching hospital for 140 years and is located one mile away from the downtown campus. For more information, visit umm.edu.