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

NCT03042143 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-09-08

No results posted yet for this study

Summary

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.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

BIOLOGICAL

Human umbilical cord derived CD362 enriched MSCs

Infusion of Human umbilical cord derived CD362 enriched MSCs

BIOLOGICAL

Placebo (Plasma-Lyte 148)

Infusion of placebo

Sponsors & Collaborators

  • Queen's University, Belfast

    collaborator OTHER

  • Northern Ireland Clinical Trials Unit

    collaborator OTHER

  • NHS Blood and Transplant

    collaborator OTHER_GOV

  • Belfast Health and Social Care Trust

    lead OTHER

Principal Investigators

  • Danny F McAuley, Professor · Belfast Health and Social Care Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2026-04-30
Completion
2026-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03042143 on ClinicalTrials.gov