Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases. In an Alliance for Regenerative Medicine (ARM) webinar on the topic, Michael Lehmicke, director, science and industry affairs at ARM, noted that developers are utilizing mesenchymal stem cells (MSCs) and other stromal cells to treat ARDS caused by COVID-19. The number of clinical trials now underway continues to increase with many more at the preclinical stage.
Webinar participant Eric Jenkins, senior medical director and head of clinical operations at Cleveland-based Athersys Inc., described the company’s work using its Multistem candidate, which is available frozen, off-the-shelf and derived from the bone marrow of adult donors. The company initiated the large, pivotal MACOVIA phase II/III study that will enroll up to 400 COVID-19 patients to treat those with moderate to severe ARDS.
In earlier work last year, results from an exploratory phase II trial completed by the company and participating pulmonary critical care centers in the U.K. and the U.S. showed that when patients with ARDS were treated with a single infusion of intravenous Multistem within the first few days of being ventilated, there was a substantial reduction in mortality, improvement in pulmonary function, increased ventilator-free days and ICU-free days during the 28-day clinical assessment period, and meaningfully better outcomes in quality of life and recovery over one