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Repair of acute respiratory distress syndrome by stromal cell administration (REALIST): a structured study protocol for an open-label dose-escalation phase 1 trial followed by a randomised, triple-blind, allocation concealed, placebo-controlled phase 2 trial.
Gorman, Ellen; Shankar-Hari, Manu; Hopkins, Phil; Tunnicliffe, William S; Perkins, Gavin D; Silversides, Jonathan; McGuigan, Peter; Jackson, Colette; Boyle, Roisin; McFerran, Jamie; McDowell, Cliona; Campbell, Christina; McFarland, Margaret; Smythe, Jon; Thompson, Jacqui; Williams, Barry; Curley, Gerard; Laffey, John G; Clarke, Mike; McAuley, Daniel F; O'Kane, Cecilia.
  • Gorman E; Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK.
  • Shankar-Hari M; Guy's and St Thomas' NHS Foundation Trust London, London, UK.
  • Hopkins P; School of Immunology and Microbial Sciences, King's College London, London, UK.
  • Tunnicliffe WS; Centre for Inflammation Research, The University of Edinburgh, Edinburgh, UK.
  • Perkins GD; Kings Trauma Centre, King's College London, London, UK.
  • Silversides J; Queen Elizabeth Hospital Birmingham, Birmingham, UK.
  • McGuigan P; Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
  • Jackson C; University Hospitals Birmingham, Birmingham, UK.
  • Boyle R; Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK.
  • McFerran J; Department of Critical Care, Belfast Health and Social Care Trust, Belfast, UK.
  • McDowell C; Department of Critical Care, Belfast Health and Social Care Trust, Belfast, UK.
  • Campbell C; Northern Ireland Clinical Trials Unit, Belfast, UK.
  • McFarland M; Northern Ireland Clinical Trials Unit, Belfast, UK.
  • Smythe J; Northern Ireland Clinical Trials Unit, Belfast, UK.
  • Thompson J; Northern Ireland Clinical Trials Unit, Belfast, UK.
  • Williams B; Northern Ireland Clinical Trials Unit, Belfast, UK.
  • Curley G; Department of Critical Care, Belfast Health and Social Care Trust, Belfast, UK.
  • Laffey JG; NHS Blood and Transplant Service, Oxford, UK.
  • Clarke M; NHS Blood and Transplant Service, Birmingham, UK.
  • McAuley DF; Independent Patient and Public Representative, Sherborne, UK.
  • O'Kane C; Royal College of Surgeons in Ireland, Dublin, Ireland.
Trials ; 23(1): 401, 2022 May 13.
Article in English | MEDLINE | ID: covidwho-1846859
ABSTRACT

BACKGROUND:

Mesenchymal stromal cells (MSCs) may be of benefit in ARDS due to immunomodulatory and reparative properties. This trial investigates a novel CD362 enriched umbilical cord derived MSC product (REALIST ORBCEL-C), produced to Good Manufacturing Practice standards, in patients with moderate to severe ARDS due to COVID-19 and ARDS due to other causes.

METHODS:

Phase 1 is a multicentre open-label dose-escalation pilot trial. Patients will receive a single infusion of REALIST ORBCEL-C (100 × 106 cells, 200 × 106 cells or 400 × 106 cells) in a 3 + 3 design. Phase 2 is a multicentre randomised, triple blind, allocation concealed placebo-controlled trial. Two cohorts of patients, with ARDS due to COVID-19 or ARDS due to other causes, will be recruited and randomised 11 to receive either a single infusion of REALIST ORBCEL-C (400 × 106 cells or maximal tolerated dose in phase 1) or placebo. Planned recruitment to each cohort is 60 patients. The primary safety outcome is the incidence of serious adverse events. The primary efficacy outcome is oxygenation index at day 7. The trial will be reported according to the Consolidated Standards for Reporting Trials (CONSORT 2010) statement.

DISCUSSION:

The development and manufacture of an advanced therapy medicinal product to Good Manufacturing Practice standards within NHS infrastructure are discussed, including challenges encountered during the early stages of trial set up. The rationale to include a separate cohort of patients with ARDS due to COVID-19 in phase 2 of the trial is outlined. TRIAL REGISTRATION ClinicalTrials.gov NCT03042143. Registered on 3 February 2017. EudraCT Number 2017-000584-33.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / Mesenchymal Stem Cells / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06220-0

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / Mesenchymal Stem Cells / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06220-0