| Trial Acronym | REALIST |
| Clinical Area | Critical Care |
| Description | Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration |
| Status | Phase 2 (ARDS not due to COVID-19) – 20 as of 01/03/2023. |
| Date Opened to Recruitment | 21/11/2018 |
| Target Recruitment | Phase 2 (ARDS not due to COVID-19) – 60 participants Phase 2 (ARDS due to COVID-19) – 60 participants Phase 1 – Up to 18 participants |
| Recruitment to date | Phase 2 (ARDS not due to COVID-19) – 20 as of 01/03/2023. Phase 2 (ARDS due to COVID-19) – Recruitment complete. Phase 1 – Recruitment complete. |
| Trial Design | An open label dose escalation phase 1 trial followed by a randomised, double-blind, allocation concealed, placebo-controlled trial. | |
| Primary Objective: | The primary objective is to assess the safety of a single intravenous infusion of MSCs in patients with ARDS due to either COVID-19 or other causes of ARDS. | |
| Secondary Objective: | Secondary objectives are to determine the effects of MSCs on:
1. Physiological indices of respiratory dysfunction reflecting severity of ARDS, as measured by oxygenation index (OI), respiratory compliance, and P/F ratio. 2.Sequential organ failure assessment (SOFA) score. 3.Extubation and reintubation. 4.Ventilation free days at day 28. 5. Duration of ventilation 6. Length of ICU and hospital stay. 7. 28-day and 90-day mortality. |
| Chief Investigator | Professor Danny McAuley |
| Sponsor | Belfast Health and Social Care Trust |
| Funder | Wellcome Trust and Research and Development Division of the Public Health Agency Northern Ireland |