Trial intelligence / Profile preview

REALIST: ORBCEL-C for ARDS

NCT03042143Phase 2

Key facts

Status: Active, not recruiting
Start: Jan 2019
Primary completion: Apr 2026
Countries: 1
Sponsor: Belfast Health and Social Care Trust
Modality: Mesenchymal Stem Cells

Drugs: Orbcel-C
Conditions: acute respiratory distress syndrome (ARDS)

Overview

Phase 2, randomised, double-blind trial in acute respiratory distress syndrome (ARDS) comparing ORBCEL-C with Placebo (2 arms). Primary endpoints: Incidence of Serious Adverse Events at 90 days and Oxygenation Index (OI) at Day 7. Started Jan 2019; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

ORBCEL-C
Single infusion of 400 million CD362 enriched MSCs.
Placebo
Single infusion of Plasma-Lyte 148.

Who it enrols

Patients with moderate to severe ARDS (onset within 1 week) receiving invasive mechanical ventilation. Excludes patients with major trauma in prior 3 days, active malignancy, severe chronic liver disease, or receiving ECLS.

Endpoints

Primary

Incidence of Serious Adverse Events90 days
Oxygenation Index (OI)Day 7

Secondary

Oxygenation IndexDay 14
Sequential Organ Failure Assessment scoreDay 14
Respiratory compliance (Crs)Day 14
Partial pressure of arterial oxygen to the fraction of inspired oxygen ratioDay 14
Driving PressureDay 14
Ventilation free days at day 28Day 28
28-day and 90-day mortalityDay 90

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