|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|