Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST)

Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive Care Units and is associated with a high mortality and a high morbidity in those who survive. ARDS occurs in approximately 20% case of COVID-19 and respiratory failure is the leading cause of mortality. There is a large economic burden with direct healthcare costs, but also indirectly due to the impact on the carer and patient through the patients inability to return to full time employment. There is little evidence for effective drug (pharmacological) treatment for ARDS. There is increasing information that mesenchymal stem cells (MSCs) might be important in treating ARDS. REALIST will investigate if a single infusion of MSCs will help in the treatment of ARDS. The first step will be to first of all determine what dose of MSCs is safe and then divide patients suffering from ARDS into two groups, one of which will get MSCs and the other a harmless dummy (or placebo) infusion, who will then be followed up to determine if lung function improves. If effective this may lead to further research to determine if MSCs are effective in patients with ARDS.

NCT Number	NCT03042143
Lead Sponsor	Belfast Health and Social Care Trust Collaborators: Queen's University, Belfast, Northern Ireland Clinical Trials Unit, NHS Blood and Transplant
Conditions	Acute Respiratory Distress Syndrome
Enrollment	129 participants
Start Date	2019-01-07
Primary Completion	2026-04 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2025-09-08