A Phase I/II Study to Assess the Safety and Efficacy of MultiStem Cell Therapy in Subjects with Acute Respiratory Distress Syndrome
Brief Description Of Study
Acute Respiratory Distress Syndrome (ARDS) is an acute injury to the lungs that causes severely low blood oxygen levels and requires a ventilator. No drug treatment currently exists for ARDS. The purpose of this study is to test the safety and tolerability of MultiStem® therapy for the treatment of moderate to severe ARDS. MultiStem therapy is an investigational medicinal product (IMP) taken from the bone marrow of a non-related donor, expanded outside the body and banked according to defined criteria. MultiStem therapy may reduce inflammation and help the lungs to heal. This product has previously been administered to over 200 subjects in other investigational trials and it was safe and well tolerated. Eligible subjects will have moderate to severe ARDS despite adequate ventilator therapy. Subjects will receive either a one-time infusion of MultiStem® therapy or a placebo, an inactive drug, while on a ventilator in the intensive care unit. The patients vital signs and laboratory values will be carefully monitored according to best clinical practices for ARDS. The study will record any potential adverse events and will monitor subjects survival, time on the ventilator, and physiologic data.