Repair of acute respiratory distress syndrome by stromal cell administration (REALIST) trial: A phase 1 trial.

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

REALIST phase 1 was an open label, dose escalation trial in which cohorts of mechanically ventilated patients with moderate to severe ARDS received increasing doses (100, 200 or 400 × 10⁶ 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

SUBMITTER: Gorman E 

PROVIDER: S-EPMC8551601 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature