1. 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
- Author
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Alexandre Sitbon, Caroline Hauw-Berlemont, Miryam Mebarki, Nicholas Heming, Julien Mayaux, Jean-Luc Diehl, Alexandre Demoule, Djillali Annane, Clémence Marois, Sophie Demeret, Emmanuel Weiss, Guillaume Voiriot, Muriel Fartoukh, Jean‐Michel Constantin, Bruno Mégarbane, Gaëtan Plantefève, Hélène Boucher-Pillet, Guillaume Churlaud, Audrey Cras, Camille Maheux, Chloé Pezzana, Mamadou Hassimiou Diallo, Said Lebbah, Jacques Ropers, Joe-Elie Salem, Christian Straus, Philippe Menasché, Jérôme Larghero, Antoine Monsel, and APHP STROMA–CoV‐2 Collaborative Research Group
- Subjects
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 ,Medicine (General) ,R5-920 ,Biochemistry ,QD415-436 - Abstract
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 (
- Published
- 2024
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