Evidence map›Paper›PMID 38637891›Full record

Trial reportStem cell research & therapy2024

Treatment of COVID-19-associated ARDS with umbilical cord-derived mesenchymal stromal cells in the STROMA-CoV-2 multicenter randomized double-blind trial: long-term safety, respiratory function, and quality of life.

Alexandre Sitbon, Caroline Hauw-Berlemont, Miryam Mebarki, Nicholas Heming, Julien Mayaux, Jean-Luc Diehl, Alexandre Demoule, Djillali Annane, Clémence Marois, Sophie Demeret and 20 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cell research & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
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

30 authors at 5 institutions in 1 country.

Alexandre SitbonMultidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, France.
Caroline Hauw-BerlemontIntensive Care Unit, APHP-CUP, Hôpital Européen Georges-Pompidou, Université Paris Cité, 75015, Paris, France.
Miryam MebarkiAPHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, 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), INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France.
Jean-Luc DiehlIntensive Care Unit, APHP-CUP, Hôpital Européen Georges-Pompidou, Université Paris Cité, 75015, Paris, France.
Alexandre DemouleAPHP, Groupe Hospitalier Universitaire-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, 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 VoiriotCentre de Recherche Saint-Antoine UMRS_938 INSERM, Assistance Publique - Hôpitaux de Paris, Service de Médecine Intensive Réanimation, Hôpital Tenon, Sorbonne Université, Paris, France.
Muriel FartoukhCentre de Recherche Saint-Antoine UMRS_938 INSERM, Assistance Publique - Hôpitaux de Paris, Service de Médecine Intensive Réanimation, Hôpital Tenon, Sorbonne Université, Paris, France.
Jean-Michel ConstantinMultidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, 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.
Hélène Boucher-PilletCentre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France.
Guillaume ChurlaudCentre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, Paris, France.
Audrey CrasAPHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, Paris, France.
Camille MaheuxCentre MEARY de Thérapie Cellulaire et Génique, APHP, Hôpital Saint-Louis, 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.
Said LebbahClinical Research Unit, Pitié-Salpêtrière University Hospital, APHP, Paris, France.
Jacques RopersClinical Research Unit, Pitié-Salpêtrière University Hospital, APHP, Paris, France.
Joe-Elie SalemInstitut National de la Santé et de la Recherche Médicale (INSERM), Assistance Publique - Hôpitaux de Paris (AP-HP), Clinical Investigation Center (CIC-1901), Regional Pharmacovigilance Centre, Department of Pharmacology, Pitié-Salpêtrière Hospital, Sorbonne Université, Paris, France.
Christian StrausINSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique; AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Département R3S (Respiration, Réanimation, Réadaptation Respiratoire, Sommeil), Service d'Explorations Fonctionnelles de la Respiration, de l'Exercice et de la Dyspnée, Sorbonne Université, 75013, Paris, France.
Philippe MenaschéINSERM UMR1140, Université Paris Cité, 75006, Paris, France.
Jérôme LargheroAPHP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies CBT501, INSERM, Université Paris Cité, Paris, France.
Antoine MonselMultidisciplinary Intensive Care Unit, Department of Anesthesiology-Critical Care and Perioperative Medicine, La Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris (APHP) Sorbonne University, 47-83, boulevard de l'Hôpital, 75651, Paris Cedex 13, France. antoine.monsel@gmail.com.ORCID 0000-0002-9647-7043
APHP STROMA–CoV‐2 Collaborative Research Group
Inserm · FRSorbonne Université · FRGene Therapy Laboratory · FRCentre Hospitalier Victor Dupouy · FRUniversité Paris Cité · FR

Funding

Agence Nationale de la Recherche ANR Flash COVID-19Direction Générale de l'offre de Soins PHRC COVID-19 2020
6 · The paper itself

Abstract

backgroundThe STROMA-CoV-2 study was a French phase 2b, multicenter, double-blind, randomized, placebo-controlled clinical trial that did not identify a significant efficacy of umbilical cord-derived mesenchymal stromal cells in patients with SARS-CoV-2-induced acute respiratory distress syndrome. Safety on day 28 was found to be good. The aim of our extended study was to assess the 6- and 12-month safety of UC-MSCs administration in the STROMA-CoV-2 cohort.

methodsA detailed multi-domain assessment was conducted at 6 and 12 months following hospital discharge focusing on adverse events, lung computed tomography-scan, pulmonary and muscular functional status, and quality of life in the STROMA-CoV-2 cohort including SARS-CoV-2-related early (< 96 h) mild-to-severe acute respiratory distress syndrome.

resultsBetween April 2020 and October 2020, 47 patients were enrolled, of whom 19 completed a 1-year follow-up. There were no significant differences in any endpoints or adverse effects between the UC-MSCs and placebo groups at the 6- and 12-month assessments. Ground-glass opacities persisted at 1 year in 5 patients (26.3%). Furthermore, diffusing capacity for carbon monoxide remained altered over 1 year, although no patient required oxygen or non-invasive ventilatory support. Quality of life revealed declines in mental, emotional and physical health throughout the follow-up period, and the six-minute walking distance remained slightly impaired at the 1-year patient assessment.

conclusionsThis study suggests a favorable safety profile for the use of intravenous UC-MSCs in the context of the first French wave of SARS-CoV-2-related moderate-to-severe acute respiratory distress syndrome, with no adverse effects observed at 1 year.

Indexed as

COVID-19Mesenchymal Stem CellsRespiratory Distress SyndromeDouble-Blind MethodHumansQuality of LifeSARS-CoV-2Treatment OutcomeUmbilical CordAcute respiratory distress syndromeFollow-up StudiesLong-term outcomesQuality of Life at six and twelve months after hospital dischargeSevere acute respiratory syndrome coronavirus‐2Umbilical cord‐ derived mesenchymal stromal cells

Identifiers

PMID38637891
PMCPMC11027516
OpenAlexW4394960792

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.