Patients were enrolled at University Hospitals Cleveland Medical Center. The program will evaluate the administration of MultiStem for the treatment of acute respiratory distress syndrome (ARDS); the therapy was recently granted fast track designation by the U.S. Food and Drug Administration (FDA) based on promising phase I/II data from its MUST-ARDS trial. As there are currently no FDA-approved medicines for the treatment of ARDS, this therapy could provide an unmet need for COVID-19 patients.

The study will enroll approximately 400 subjects who will receive open-label, single-active treatment to evaluate the safety of MultiStem administered at two dose levels to patients with moderate to severe ARDS associated with COVID-19. If MultiStem is deemed efficacious, safe, and tolerable, the company will further evaluate the treatment with a double-blind, randomized, and placebo-controlled trial protocol.

The company is working with Medpace, a contract research organization, for the study. The firm is also in discussions with the Biomedical Advanced Research and Development Authority (BARDA) to expedite the development of its therapy.