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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

  • 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.

  • 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