NDLI: 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

Content Provider	Springer Nature : BioMed Central
Author	Sitbon, Alexandre Hauw-Berlemont, Caroline Mebarki, Miryam Heming, Nicholas Mayaux, Julien Diehl, Jean-Luc Demoule, Alexandre Annane, Djillali Marois, Clémence Demeret, Sophie Weiss, Emmanuel Voiriot, Guillaume Fartoukh, Muriel Constantin, Jean‐Michel Mégarbane, Bruno Plantefève, Gaëtan Boucher-Pillet, Hélène Churlaud, Guillaume Cras, Audrey Maheux, Camille Pezzana, Chloé Diallo, Mamadou Hassimiou Lebbah, Said Ropers, Jacques Salem, Joe-Elie Straus, Christian Menasché, Philippe Larghero, Jérôme Monsel, Antoine
Abstract	Background The 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. Methods A 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. Results Between 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. Conclusions This 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.
Related Links	https://stemcellres.biomedcentral.com/counter/pdf/10.1186/s13287-024-03729-w.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	17576512
DOI	10.1186/s13287-024-03729-w
Journal	Stem Cell Research & Therapy
Issue Number	1
Volume Number	15
Language	English
Publisher	BioMed Central
Publisher Date	2024-04-19
Access Restriction	Open
Subject Keyword	Stem Cells Cell Biology Regenerative Medicine Tissue Engineering Biomedical Engineering and Bioengineering Severe acute respiratory syndrome coronavirus‐2 Acute respiratory distress syndrome Umbilical cord‐ derived mesenchymal stromal cells Long-term outcomes Follow-up Studies Quality of Life at six and twelve months after hospital discharge Regenerative Medicine/Tissue Engineering
Content Type	Text
Resource Type	Article
Subject	Cell Biology Medicine Biochemistry, Genetics and Molecular Biology Molecular Medicine
Journal Impact Factor	7.1/2023
5-Year Journal Impact Factor	7.9/2023

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