Updated on May 1, 2020 at 12pm
Athersys, a biotechnology company in Cleveland, has been developing a possible therapy for serious medical conditions such as acute respiratory distress syndrome (ARDS) – one of the more concerning complications caused by COVID-19.
The company announced in a press release on Friday May 1, 2020, that University Hospitals is starting a clinical trial testing the effectiveness of this treatment on patients with COVID-19 induced ARDS.
The trial will test MultiStem, a stem cell therapy. The key question under investigation is whether patients receiving MultiStem require fewer days on a ventilator, compared to those given a placebo.
The Food and Drug Administration fast-tracked the clinical trial on April 13.
University Hospitals is now screening patients with COVID-19 induced ARDS for participation in the trial. UH's Dr. Frank Jacono will serve as the principal investigator.
ARDS is a type of respiratory failure characterized by inflammation of the lungs. Currently, there are no approved drugs to treat ARDS. Chinese researchers in Wuhan found COVID-19 patients had a high death rate if they also developed ARDS.
Athersys began testing MultiStem on ARDS patients in 2015.
Results of the early stage clinical trial showed the patients who were administered the treatment had lower mortality rates, shorter stays in the ICU and were off ventilators sooner, according to the company.
Athersys CEO Gil Van Bokkelen said the company is working with many partners in developing the trial, including the Biomedical Advanced Research Development Authority (BARDA), an agency under the U.S. Department of Health and Human Services.
Bokkelen said BARDA approached the company about studying MultiStem’s efficacy for COVID-19-induced ARDS patients back in January.
He said BARDA is interested in MultiStem because it could help with future outbreaks. He said when viral outbreaks occur, initial treatments that are developed are often geared toward the specific pathogen, but they might not be relevant to other pathogens.
“Our therapy is…basically focusing on the problem that the virus causes in the body, which is a severe lung inflammation, and works through a variety of different mechanisms to help the lung function get better, help the patient get better, and ultimately get them on the path to recovery," he said.