REALIST

Repair of ARDS by Stromal Cell Administration (REALIST)

Trial summary: Repair of ARDS by Stromal Cell Administration (REALIST)

Type: Interventional

Site and lead:

  • Manchester Royal Infirmary: Dr Jonathan Bannard-Smith

Patient group: COVID-19 patients in ICU

Intervention

  • 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.