Stem Cell Therapy for ARDS

Acute respiratory distress syndrome (ARDS) can be brought on by COVID-19 and without any approved medication to treat it, patients can be put on a ventilator.

Cleveland, Ohio-based Athersys has developed its MultiStem cell therapy and is studying it for COVID-19 related ARDS. MultiStem is a regenerative candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage.

The therapy was recently given a Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration (FDA) for ARDS. This allows sponsors to work closely with the FDA and receive their guidance on expediting development of their products.

Prior to this designation, Athersys had completed research exploring MultiStem for the treatment of pulmonary distress and recently completed an exploratory Phase 1/2 clinical trial for the treatment of ARDS.

They reported encouraging data from the study, and decided to also explore treatment for COVID-19.

As such, the company has initiated a phase 2/3 clinical trial evaluating MultiStem for the treatment of COVID-19 induced ARDS, which is now enrolling patients. The primary efficacy endpoint for the randomized, double-blind, placebo-controlled study will compare the number of ventilator-free days through day 28 among MultiStem and placebo treatment groups.

Secondary objectives of the study are to evaluate 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability, and quality of life among survivors through one-year of follow-up.

Contagion® recently spoke to Athersys CEO Gil Van Bokkelen, PhD, and CFO Ivor Macleod, MBA, CPA about the investigative therapy and the company.