학술논문
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
Document Type
Clinical report
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; MenascheÌ, Philippe; Larghero, Jérôme; Monsel, Antoine; Benchetrit, Déborah; Bonvallot, Harold; Charbonnier-Beaupel, Fanny; Dhib-Charfi, Meriem; Delmotte, Pierre Romain; Kone, Assitan; Le Corre, Marine; Metz, Carole; Puybasset, Louis; Vezinet, Corinne
Source
Stem Cell Research & Therapy. April 19, 2024, Vol. 15 Issue 1
Subject
Language
English
ISSN
1757-6512
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. Keywords: 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
Author(s): Alexandre Sitbon[sup.1], Caroline Hauw-Berlemont[sup.2], Miryam Mebarki[sup.3], Nicholas Heming[sup.4], Julien Mayaux[sup.5], Jean-Luc Diehl[sup.2,6,7], Alexandre Demoule[sup.5], Djillali Annane[sup.4], Clémence Marois[sup.8,9], Sophie Demeret[sup.8,9], Emmanuel Weiss[sup.10,11], Guillaume Voiriot[sup.12], Muriel Fartoukh[sup.12], Jean-Michel Constantin[sup.1], Bruno [...]
Author(s): Alexandre Sitbon[sup.1], Caroline Hauw-Berlemont[sup.2], Miryam Mebarki[sup.3], Nicholas Heming[sup.4], Julien Mayaux[sup.5], Jean-Luc Diehl[sup.2,6,7], Alexandre Demoule[sup.5], Djillali Annane[sup.4], Clémence Marois[sup.8,9], Sophie Demeret[sup.8,9], Emmanuel Weiss[sup.10,11], Guillaume Voiriot[sup.12], Muriel Fartoukh[sup.12], Jean-Michel Constantin[sup.1], Bruno [...]