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Cleveland biotechnology company Athersys Inc received Fast Track designation from the U.S. Food and Drug Administration in acute respiratory distress syndrome, or ARDS.
In January 2019,the company ran a randomized, double-blind placebo-controlled exploratory Phase 2 clinical study evaluating MultiStem administration to patients with ARDS.
In the study, patients who received MultiStem treatment within several days after being diagnosed with ARDS and being placed on a ventilator experienced lower mortality, increased ventilator-free days, and increased ICU-free days during the initial 28-day clinical assessment period relative to patients receiving placebo.
Athersys' partner in Japan, Healios K.K., enrolled patients in a clinical trial evaluating administration of MultiStem to pneumonia-induced ARDS patients in Japan.
