Repair of acute respiratory distress syndrome by stromal cell administration (REALIST) trial: A phase 1 trial
Ellen Gorman, Manu Shankar‐Hari, Philip Hopkins, William Tunnicliffe, Gavin D. Perkins, Jonathan A. Silversides, Peter J. McGuigan, Anna Krasnodembskaya, Colette E. Jackson, Roisin Boyle, Jamie McFerran, Clíona McDowell, Christina Campbell, Margaret McFarland, Jon Smythe, Jacqui Thompson, Barry Williams, Gerard F. Curley, John G. Laffey, Mike Clarke, Daniel F. McAuley, Cecilia O’Kane
Abstract
BACKGROUND: Mesenchymal stromal cells (MSCs) may be of benefit in acute respiratory distress syndrome (ARDS) due to immunomodulatory, reparative, and antimicrobial actions. ORBCEL-C is a population of CD362 enriched umbilical cord-derived MSCs. The REALIST phase 1 trial investigated the safety and feasibility of ORBCEL-C in patients with moderate to severe ARDS. METHODS: cells) of a single intravenous infusion of ORBCEL-C in a 3 + 3 design. The primary safety outcome was the incidence of serious adverse events. Dose limiting toxicity was defined as a serious adverse reaction within seven days. Trial registration clinicaltrials.gov NCT03042143. FINDINGS: = 4/9). INTERPRETATION: cells.