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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
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(2022) 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. Trials, 23 (1). 401. doi:10.1186/s13063-022-06220-0
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WRAP-Repair-of-acute-respiratory-distress-syndrome-by-stromal-cell-administration-REALIST-Perkins-22.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (625Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s13063-022-06220-0
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 1:1 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
| Item Type: | Journal Item | |||||||||
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| Subjects: | R Medicine > RC Internal medicine | |||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Respiratory distress syndrome, Adult -- Treatment, Mesenchymal stem cells, Cellular therapy, Clinical trials, COVID-19 (Disease) | |||||||||
| Journal or Publication Title: | Trials | |||||||||
| Publisher: | Biomed Central | |||||||||
| ISSN: | 1745-6215 | |||||||||
| Official Date: | 13 May 2022 | |||||||||
| Dates: |
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| Volume: | 23 | |||||||||
| Number: | 1 | |||||||||
| Number of Pages: | 15 | |||||||||
| Article Number: | 401 | |||||||||
| DOI: | 10.1186/s13063-022-06220-0 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||
| Date of first compliant deposit: | 5 July 2022 | |||||||||
| Date of first compliant Open Access: | 6 July 2022 | |||||||||
| RIOXX Funder/Project Grant: |
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