Researchers at the University of Maryland School of Medicine are participating in a trial of an experimental stem cell therapy for some of the sickest COVID-19 patients who are on ventilators.
The study is one of many going on in Maryland and elsewhere that are testing existing drug therapies, as well as new ones, to treat the disease caused by the coronavirus.
This drug was developed by Mesoblast Ltd., an Australian company that develops cell therapies. It is designed for those with moderate to severe cases of severe acute respiratory distress syndrome, called ARDS. The trial will assess whether it shortens recovery time and reduces death from COVID-19.
The illness has sickened more than 5 million people worldwide, killing almost 330,000 of them.
“This stem cell therapy is a potential new therapy in our treatment arsenal to battle COVID-19,” Dr. Sunjay Kaushal, professor of surgery in the School of Medicine and chief of the University of Maryland Congenital Heart Disease Outreach Program, said in a statement.
“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,” he said. “We are eager to see whether remestemcel-L can reduce mortality in these patients.”
Remestemcel-L was developed for various inflammatory conditions, and researchers say it could reduce COVID-19 related inflammation by reducing the production of pro-inflammatory chemicals called cytokines.
Some COVID-19 patients have suffered potentially fatal levels of inflammation caused by a heightened immune response. Patients with ARDS have extensive inflammation in the lungs.
A preliminary study in 12 patients on ventilators at Mount Sinai Hospital in New York found that 10 of them survived and nine were removed from the ventilators in a median of 10 days, Mesoblast announced in late April. The compassionate-use study involved two infusions of remestemcel-L, and the results were significantly better than in the patient pool in other hospitals in hard-hit New York City at the time, the company said.
“The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent,” said Dr. Silviu Itescu, Mesoblast’s CEO, in a statement at the time. "We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.”
The first patient in that next study was enrolled at the University of Maryland Medical Center. The trial aims to enroll 300 patients at up to 30 sites, including university system hospitals and other U.S. sites, over the next three or four months. If the drug appears to be working well or not working at all, the trial could end early. The drug could cause negative immune system reactions, researchers said.
Mesoblast is funding the study, which is being overseen by doctors at the Institute for Transformative Clinical Trials at the Icahn School of Medicine at Mount Sinai.
“This rapid mobilization of major medical centers across the United States reflects the urgent need to treat the very large numbers of people in hospital intensive care units suffering with COVID-19 ARDS and requiring ventilation," said Dr. Alan Moskowitz, a co-director of the Mount Sinai institute, in a statement. "We expect quick enrollment in this trial to determine whether remestemcel-L can reduce mortality in these patients.”