| Trial Acronym | REALIST |
| Clinical Area | Critical Care |
| Trial Title | Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration |
| Trial Status | Follow Up |
| Trial Registration | https://clinicaltrials.gov/study/NCT03042143 |
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Recruitment
Recruitment Target Phase 1 – 18 Phase 2 (ARDS due to COVID-19) – 60
Phase 2 (ARDS not due to COVID-19) – 60
Date Open to Recruitment November 2018 Recruitment Phase 1 – 9 (complete) Phase 2 (ARDS due to COVID-19) – 60 (complete)
Phase 2 (ARDS not due to COVID-19) – 60 (complete)
Date Closed to Recruitment April 2024 -
Trial Design
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.
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Chief Investigator (CI)
Chief Investigator Professor Danny McAuley, Queen’s University Belfast -
Sponsor(s) & Funder(s)
Sponsor Belfast Health and Social Care Trust Funder Wellcome Trust and Research and Development Division of the Public Health Agency Northern Ireland