The first COVID-19 patient in Texas has been enrolled in a stem cell therapy clinical trial for acute respiratory distress syndrome (ARDS) at The University of Texas Health Science Center at Houston (UTHealth).
The procedure took place April 16, 2020, at Memorial Hermann-Texas Medical Center.
ARDS is a serious condition of the lungs, in which they fill up with fluid and cannot supply the oxygen needed for organs throughout the body. In severe cases, patients with COVID-19 have developed ARDS, which requires a patient being placed on a ventilator.
The Phase IIb randomized trial uses allogenic, bone marrow-derived mesenchymal stromal cells (hMSCs), which have been shown in preclinical trials to help regulate the immune response, lowering inflammation and reducing the severity of organ injury.
“Mesenchymal stem cells have the ability to modulate the inflammatory response that plays a key role in the development of ARDS. This makes them a very promising therapy for treating patients with the severe respiratory failure we are seeing in COVID-19 patients,” said Laura J. Moore, MD, co-principal investigator of the Texas site of the national trial and professor in the Department of Surgery with McGovern Medical School at UTHealth.
“Patients with ARDS from COVID-19 have a mortality rate up to 60%,” said Bela Patel, MD, co-principal investigator and director of the Division of Critical Care at McGovern Medical School. “Since stem cell therapy may modulate the hyperinflammatory response to SARS-CoV-2, which causes COVID-19, this important study represents a promising potential therapy to improving outcomes in ARDS patients including those with COVID-19 ARDS.” Patel is the Graham Distinguished University Chair and vice dean of Healthcare Quality at McGovern Medical School, and executive medical director of Critical Care for Memorial Hermann-TMC.
Participants in the study are randomized to receive either the hMSCs or a placebo. A total of 120 patients will be enrolled in the national, multisite trial, which is led by Michael Matthay, MD, at the University of California-San Francisco.
For the UTHealth arm of the study, the hMSCs are processed at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory at McGovern Medical School. The study builds on a long history of stem cell therapy at UTHealth begun by Charles S. Cox Jr., MD, the George and Cynthia Mitchell Distinguished Chair in Neurosciences, director of the Program in Children’s Regenerative Medicine at McGovern Medical School, and director of the Pediatric Trauma Program at Children’s Memorial Hermann Hospital. Cox is also a faculty member of MD Anderson Cancer Center UTHealth Graduate School of Biomedical Sciences.
“This represents another translation of cell-based therapies at UTHealth," Cox said. "The unifying theme of this approach is the dampening of the immune response to injury.”
UTHealth co-investigators include Cox; Lillian Kao, MD; Charles Wade, PhD; and Erin Fox, PhD. Wade is the James H. “Red” Duke, Jr., MD, Distinguished Professor in Surgery. Kao is the Jack H. Mayfield, MD, Chair in Surgery and division director of Acute Care Surgery. Fox is associate professor in the Center for Translational Injury Research.