Dataset Information

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

ABSTRACT:

Background

Severe 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.

Methods

This 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 10⁶ UC-MSCs/kg or placebo (0.9% NaCl) over 5 days after recruitment. For the modified intention-to-treat population, the primary endpoint was the partial pressure of oxygen to fractional inspired oxygen (PaO₂/FiO₂)-ratio change between baseline (day (D) 0) and D7.

Results

Among the 107 patients screened for eligibility from April 6, 2020, to October 29, 2020, 45 were enrolled, randomized and analyzed. PaO₂/FiO₂ changes between D0 and D7 did not differ significantly between the UC-MSCs and placebo groups (medians [IQR] 54.3 [- 15.5 to 93.3] vs 25.3 [- 33.3 to 104.6], respectively; ANCOVA estimated treatment effect 7.4, 95% CI - 44.7 to 59.7; P = 0.77). Six (28.6%) of the 21 UC-MSCs recipients and six of 24 (25%) placebo-group patients experienced serious adverse events, none of which were related to UC-MSCs treatment.

Conclusions

D0-to-D7 PaO₂/FiO₂ changes for intravenous UC-MSCs-versus placebo-treated adults with SARS-CoV-2-induced ARDS did not differ significantly. Repeated UC-MSCs infusions were not associated with any serious adverse events during treatment or thereafter (until D28). Larger trials enrolling patients earlier during the course of their ARDS are needed to further assess UC-MSCs efficacy in this context.

Trial registration

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

SUBMITTER: Monsel A

PROVIDER: S-EPMC8860258 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Monsel Antoine A Hauw-Berlemont Caroline C Mebarki Miryam M Heming Nicholas N Mayaux Julien J Nguekap Tchoumba Otriv O Diehl Jean-Luc JL Demoule Alexandre A Annane Djillali D Marois Clémence C Demeret Sophie S Weiss Emmanuel E Voiriot Guillaume G Fartoukh Muriel M Constantin Jean-Michel JM Mégarbane Bruno B Plantefève Gaëtan G Malard-Castagnet Stéphanie S Burrel Sonia S Rosenzwajg Michelle M Tchitchek Nicolas N Boucher-Pillet Hélène H Churlaud Guillaume G Cras Audrey A Maheux Camille C Pezzana Chloé C Diallo Mamadou Hassimiou MH Ropers Jacques J Menasché Philippe P Larghero Jérôme J

Critical care (London, England) 20220221 1

<h4>Background</h4>Severe 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.<h4>Methods</h4>This multicentre, double-blind, randomized, placebo-con ...[more]

PMID: 35189925

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Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

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