Evidence map›Paper›PMID 35562778›Full record

ArticleTrials2022

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.

Ellen Gorman, Manu Shankar-Hari, Phil Hopkins, William S Tunnicliffe, Gavin D Perkins, Jonathan Silversides, Peter McGuigan, Colette Jackson, Roisin Boyle, Jamie McFerran and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03042143 (Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03042143 phase1 / phase2active not recruitingnot on this map

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST): An Open Label Dose Escalation Phase 1 Trial Followed by a Randomised, Double-blind, Allocation Concealed, Placebo-controlled Trial.

TypeinterventionalSponsorBelfast Health and Social Care TrustRan2019 to 2026Enrolled129ConditionsAcute Respiratory Distress SyndromeArmsHuman umbilical cord derived CD362 enriched MSCs, Placebo (Plasma-Lyte 148)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Cell-based Therapies for Acute Respiratory Distress Syndrome: Where Are We Now?American journal of respiratory and critical care medicine · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 8 institutions in 2 countries.

Ellen GormanWellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK.
Manu Shankar-HariGuy's and St Thomas' NHS Foundation Trust London, London, UK.
Phil HopkinsKings Trauma Centre, King's College London, London, UK.
William S TunnicliffeQueen Elizabeth Hospital Birmingham, Birmingham, UK.
Gavin D PerkinsWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Jonathan SilversidesWellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK.
Peter McGuiganDepartment of Critical Care, Belfast Health and Social Care Trust, Belfast, UK.
Colette JacksonNorthern Ireland Clinical Trials Unit, Belfast, UK.
Roisin BoyleNorthern Ireland Clinical Trials Unit, Belfast, UK.
Jamie McFerranNorthern Ireland Clinical Trials Unit, Belfast, UK.
Cliona McDowellNorthern Ireland Clinical Trials Unit, Belfast, UK.
Christina CampbellNorthern Ireland Clinical Trials Unit, Belfast, UK.
Margaret McFarlandDepartment of Critical Care, Belfast Health and Social Care Trust, Belfast, UK.
Jon SmytheNHS Blood and Transplant Service, Oxford, UK.
Jacqui ThompsonNHS Blood and Transplant Service, Birmingham, UK.
Barry WilliamsIndependent Patient and Public Representative, Sherborne, UK.
Gerard CurleyRoyal College of Surgeons in Ireland, Dublin, Ireland.
John G LaffeyRegenerative Medicine Institute (REMEDI) at CÚRAM Centre for Research in Medical Devices, National University of Ireland, Galway, Ireland.
Mike ClarkeNorthern Ireland Clinical Trials Unit, Belfast, UK.
Daniel F McAuleyWellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK.
Cecilia O'KaneWellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK. c.okane@qub.ac.uk.
Belfast Health and Social Care Trust · GBKing's College London · GBNHS Blood and Transplant · GBQueen's University Belfast · GBOllscoil na Gaillimhe – University of Galway · IEQueen Elizabeth Hospital Birmingham · GBRoyal College of Surgeons in Ireland · IEUniversity of Warwick · GB

Funding

Medical Research Council MR/M009149/1Wellcome Trust 106939/Z/15/Z
6 · The paper itself

Abstract

backgroundMesenchymal 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.

methodsPhase 1 is a multicentre open-label dose-escalation pilot trial. Patients will receive a single infusion of REALIST ORBCEL-C (100 × 10 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 registrationClinicalTrials.gov NCT03042143. Registered on 3 February 2017. EudraCT Number 2017-000584-33.

Indexed as

COVID-19Mesenchymal Stem CellsRespiratory Distress SyndromeClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDouble-Blind MethodHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeAcute respiratory distress syndromeClinical trialCOVID-19Mesenchymal stem cellsMesenchymal stromal cellsMSCsProtocol

Identifiers

PMID35562778
PMCPMC9099345
OpenAlexW4280516257

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.