University of Minnesota opens clinical trial for new treatment of COVID-19
MINNEAPOLIS, MN- August 13, 2020 - A patient with COVID-19 and lung failure at the University of Minnesota is the first to be treated in the U.S. on a new FDA-approved clinical trial determining the safety and effectiveness of mesenchymal stem cells (MSCs). This new treatment — for some of the sickest patients with COVID-19 — is aimed at halting the intense inflammatory response of the body, referred to as a “cytokine storm.” The cytokine storm is caused by the body’s immune response to the coronavirus and, if unchecked, can cause extensive organ damage, most often lung failure.
The study is led by David Ingbar, MD, a critical care and pulmonary physician at the M Health Fairview University of Minnesota Medical Center (UMMC) and director of the University of Minnesota Medical School’s Division of Pulmonary, Allergy, Critical Care and Sleep Medicine. He also served as the President of the American Thoracic Society – the largest U.S. critical care and pulmonary organization.
“The inflammation seen in patients with severe COVID-19 can be devastating,” said Ingbar. “The cytokine storm can rapidly lead to shock, massive fluid buildup in the tissues, and direct severe tissue injury, most often in the lungs.”
This study, led and developed by the team of researchers at the University of Minnesota, will include other academic centers across the U.S. The multisite study is open now at M Health Fairview UMMC and Bethesda Hospital, which was previously converted into the state's first dedicated COVID-19 care facility.
“The study will determine the effect of MSCs on stopping the cytokine storm,” said John E. Wagner, MD, cancer researcher and director of the Institute for Cell, Gene and Immunotherapy at the University of Minnesota. “In order to determine the real benefit of MSCs in these very ill patients, patients will be randomized to receive three doses of MSC 48 hours apart or a placebo solution.”
MSCs have been used successfully in other inflammatory diseases, and single doses of MSCs have been piloted in patients with COVID-19 in other countries, including China and Italy. Prior laboratory research suggests that MSC will blunt the cytokine storm and protect lung tissue from damage from the inflammatory response to the virus.
The MSCs used in this study were produced and manufactured at the U of M’s Molecular and Cellular Therapeutics (MCT) center, which offers full-service development and manufacturing of cell- and tissue-based products, monoclonal antibodies and other therapeutic proteins, as well as active pharmaceutical ingredients for use in Phase I, II or III clinical trials.
About the Masonic Cancer Center, University of Minnesota
The Masonic Cancer Center, University of Minnesota, is the Twin Cities’ only Comprehensive Cancer Center, designated ‘Outstanding’ by the National Cancer Institute. As Minnesota’s Cancer Center, we have served the entire state for more than 25 years. Our researchers, educators, and care providers have worked to discover the causes, prevention, detection, and treatment of cancer and cancer-related diseases. Learn more at www.cancer.umn.edu.
About the University of Minnesota Medical School
The University of Minnesota Medical School is at the forefront of learning and discovery, transforming medical care and educating the next generation of physicians. Our graduates and faculty produce high-impact biomedical research and advance the practice of medicine. Learn how the University of Minnesota is innovating all aspects of medicine by visiting www.med.umn.edu.