Repair of Acute Respiratory Distress Syndrome in COVID-19 by Stromal Cells (REALIST-COVID trial).

Mesenchymal stromal cells are a potential therapeutic for Acute Respiratory Distress Syndrome due to COVID-19, with pleiotropic immunomodulatory and reparative properties.This study investigated the safety and efficacy of ORBCEL-C (CD362 enriched umbilical cord-derived Mesenchymal Stromal Cells) in this patient population. Overall design: In this multicentre, randomised, double-blind, allocation concealed, placebo-controlled trial (registration number NCT03042143), mechanically ventilated patients with moderate to severe Acute Respiratory Distress Syndrome due to COVID-19 were randomised to receive a single intravenous infusion of ORBCEL-C (400 x 106 cells) or placebo (Plasma-Lyte 148). Whole blood RNA sequencing was performed on samples at day 0, 4, and 7.