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
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...
April 19, 2024: Stem Cell Research & Therapy