Evidence map›Paper›PMID 35189925›Full record

Trial reportCritical care (London, England)2022

Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial.

Antoine Monsel, Caroline Hauw-Berlemont, Miryam Mebarki, Nicholas Heming, Julien Mayaux, Otriv Nguekap Tchoumba, Jean-Luc Diehl, Alexandre Demoule, Djillali Annane, Clémence Marois and 21 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04333368 (Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS), which is not on this map. Cited by 77 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 14 pooled it
–field-weighted citation impact
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.

NCT04333368 phase1 / phase2completednot on this map

Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2020 to 2021Enrolled47ConditionsSevere Acute Respiratory Syndrome Coronavirus 2, Severe Acute Respiratory Distress SyndromeArmsUmbilical cord Wharton's jelly-derived human, NaCl 0.9%
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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17 more citing papers are in PubMed but not listed here.

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

31 authors.

Antoine MonselMultidisciplinary Intensive Care Unit, Department of Anesthesiology and Critical Care, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, Paris, France. antoine.monsel@gmail.com.ORCID 0000-0002-9647-7043
Caroline Hauw-Berlemont *Intensive Care Unit, APHP-CUP, Hôpital Européen Georges-Pompidou, Université de Paris, 75015, Paris, France.
Miryam Mebarki *APHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université de Paris, Paris, France.
Nicholas HemingFHU SEPSIS, Department of Intensive Care, Hôpital Raymond-Poincaré (APHP), Laboratory of Infection & Inflammation-INSERM U1173, Simone Veil School of Medicine, University Versailles Saint Quentin-University Paris Saclay, 92380, Garches, France.
Julien MayauxAPHP, Groupe Hospitalier Universitaire-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), and Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.
Otriv Nguekap TchoumbaSorbonne Université-INSERM UMRS_959, Immunology-Immunopathology-Immunotherapy (I3), 75013, Paris, France.
Jean-Luc DiehlIntensive Care Unit, APHP-CUP, Hôpital Européen Georges-Pompidou, Université de Paris, 75015, Paris, France.
Alexandre DemouleAPHP, Groupe Hospitalier Universitaire-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), and Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.
Djillali AnnaneFHU SEPSIS, Department of Intensive Care, Hôpital Raymond-Poincaré (APHP), Laboratory of Infection & Inflammation-INSERM U1173, Simone Veil School of Medicine, University Versailles Saint Quentin-University Paris Saclay, 92380, Garches, France.
Clémence MaroisNeurological Intensive Care Unit, Department of Neurology, La Pitié-Salpêtrière Hospital, APHP, Sorbonne University, Paris, France.
Sophie DemeretNeurological Intensive Care Unit, Department of Neurology, La Pitié-Salpêtrière Hospital, APHP, Sorbonne University, Paris, France.
Emmanuel WeissDepartment of Anesthesiology and Critical Care, Beaujon Hospital, DMU PARABOL, APHP Nord, Paris, France.
Guillaume VoiriotService de Médecine Intensive Réanimation, Hôpital Tenon, APHP, Sorbonne Université, Paris, France.
Muriel FartoukhService de Médecine Intensive Réanimation, Hôpital Tenon, APHP, Sorbonne Université, Paris, France.
Jean-Michel ConstantinMultidisciplinary Intensive Care Unit, Department of Anesthesiology and Critical Care, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, Paris, France.
Bruno MégarbaneDepartment of Medical and Toxicological Critical Care, Lariboisière Hospital, INSERM UMRS1144, University of Paris, Paris, France.
Gaëtan PlantefèveService de Réanimation Polyvalente, Centre Hospitalier Victor Dupouy, 69, Rue du Lieutenant-Colonel Prud'hon, 95100, Argenteuil, France.
Stéphanie Malard-CastagnetImmunology and HLA Laboratory, Hôpital Saint-Louis, Paris, France.
Sonia BurrelINSERM U1136, Institut Pierre-Louis d'Epidémiologie et de Santé Publique (iPLESP), APHP, Hôpital Pitié-Salpêtrière, Service de Virologie, Sorbonne Université, Paris, France.
Michelle RosenzwajgSorbonne Université-INSERM UMRS_959, Immunology-Immunopathology-Immunotherapy (I3), 75013, Paris, France.
Nicolas TchitchekSorbonne Université-INSERM UMRS_959, Immunology-Immunopathology-Immunotherapy (I3), 75013, Paris, France.
Hélène Boucher-PilletAPHP, Hôpital Saint-Louis, Centre MEARY de Thérapie Cellulaire et Génique, Paris, France.
Guillaume ChurlaudAPHP, Hôpital Saint-Louis, Centre MEARY de Thérapie Cellulaire et Génique, Paris, France.
Audrey CrasAPHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université de Paris, Paris, France.
Camille MaheuxAPHP, Hôpital Saint-Louis, Centre MEARY de Thérapie Cellulaire et Génique, Paris, France.
Chloé PezzanaINSERM, UMR S 970, Paris Centre de Recherche Cardiovasculaire (PARCC), Université de Paris, Paris, France.
Mamadou Hassimiou DialloClinical Research Unit, Pitié-Salpêtrière University Hospital, APHP, Paris, France.
Jacques RopersClinical Research Unit, Pitié-Salpêtrière University Hospital, APHP, Paris, France.
Philippe Menasché *Department of Cardiovascular Surgery, Hôpital Européen Georges-Pompidou, Paris, France.
Jérôme Larghero *APHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université de Paris, Paris, France.
APHP STROMA–CoV-2 Collaborative Research Group

Funding

Agence Nationale de la Recherche ANR20COVI0016Direction Générale de l'offre de Soins COVID-19-20-0004
6 · The paper itself

Abstract

backgroundSevere acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-induced acute respiratory distress syndrome (ARDS) causes high mortality. Umbilical cord-derived mesenchymal stromal cells (UC-MSCs) have potentially relevant immune-modulatory properties, whose place in ARDS treatment is not established. This phase 2b trial was undertaken to assess the efficacy of UC-MSCs in patients with SARS-CoV-2-induced ARDS.

methodsThis multicentre, double-blind, randomized, placebo-controlled trial (STROMA-CoV-2) recruited adults (≥ 18 years) with SARS-CoV-2-induced early (< 96 h) mild-to-severe ARDS in 10 French centres. Patients were randomly assigned to receive three intravenous infusions of 10

resultsAmong the 107 patients screened for eligibility from April 6, 2020, to October 29, 2020, 45 were enrolled, randomized and analyzed. PaO

conclusionsD0-to-D7 PaO

trial registrationNCT04333368. Registered 01 April 2020, https://clinicaltrials.gov/ct2/history/NCT04333368 .

Indexed as

COVID-19Mesenchymal Stem CellsRespiratory Distress SyndromeDouble-Blind MethodHumansSARS-CoV-2Treatment OutcomeAcute respiratory distress syndromeGood-manufacturing practiceSevere acute respiratory syndrome coronavirus-2Umbilical cord-derived mesenchymal stromal cells

Identifiers

PMID35189925
PMCPMC8860258

What Socratic holds

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LicenceCC BY
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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 Socratic graph.