Repair of ARDS by Stromal Cell Administration (REALIST)
Trial summary: Repair of ARDS by Stromal Cell Administration (REALIST)
Site and lead:
- Manchester Royal Infirmary: Dr Jonathan Bannard-Smith
Patient group: COVID-19 patients in ICU
- Allogeneic unrelated donor human umbilical cord-derived CD362 enriched Mesenchymal Stromal Cells (REALIST ORBCEL-C)
Funder: Wellcome Trust
Sponsor: Belfast Health and Social Care Trust
More about REALIST
- REALIST is a nationally-prioritised COVID-19 study. See the full list Urgent Public Health COVID-19 Studies on the NIHR website.
The primary purpose of this study is to conduct a phase 1 and a phase 2 clinical trial of human umbilical cord derived CD362 enriched Mesenchymal Stem Cells (MSC), (REALIST ORBCEL-C cells), in patients with Acute Respiratory Distress Syndrome (ARDS).
The phase 1 trial is an open label dose escalation pilot study in which cohorts of subjects with moderate to severe ARDS will receive increasing doses of a single infusion of REALIST ORBCEL-C in a 3+3 design.
The phase 2 study will evaluate safety and efficacy outcomes in patients with ARDS due to COVID-19 who have been administered MSC therapy. Although the primary focus of the phase 2 trial is safety, several outcomes will be evaluated to determine whether treatment with MSCs shows efficacy for important outcomes in patients with ARDS due to COVID-19.