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Stem Cell Res Ther
. 2024 Apr 19;15(1):109.
doi: 10.1186/s13287-024-03729-w. 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
Alexandre Sitbon 1 , Caroline Hauw-Berlemont 2 , Miryam Mebarki 3 , Nicholas Heming 4 , Julien Mayaux 5 , Jean-Luc Diehl 2 6 7 , Alexandre Demoule 5 , Djillali Annane 4 , Clémence Marois 8 9 , Sophie Demeret 8 9 , Emmanuel Weiss 10 11 , Guillaume Voiriot 12 , Muriel Fartoukh 12 , Jean-Michel Constantin 1 , Bruno Mégarbane 13 , Gaëtan Plantefève 14 , Hélène Boucher-Pillet 15 , Guillaume Churlaud 15 , Audrey Cras 3 16 , Camille Maheux 15 , Chloé Pezzana 17 , Mamadou Hassimiou Diallo 18 , Said Lebbah 18 , Jacques Ropers 18 , Joe-Elie Salem 19 , Christian Straus 20 , Philippe Menasché 16 21 , Jérôme Larghero 3 15 , Antoine Monsel 22 23 24 ; APHP STROMA–CoV‐2 Collaborative Research Group
Collaborators, Affiliations
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: Acute respiratory distress syndrome; Follow-up Studies; Long-term outcomes; Quality of Life at six and twelve months after hospital discharge; Severe acute respiratory syndrome coronavirus‐2; Umbilical cord‐ derived mesenchymal stromal cells.
. 2024 Apr 19;15(1):109.
doi: 10.1186/s13287-024-03729-w. 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
Alexandre Sitbon 1 , Caroline Hauw-Berlemont 2 , Miryam Mebarki 3 , Nicholas Heming 4 , Julien Mayaux 5 , Jean-Luc Diehl 2 6 7 , Alexandre Demoule 5 , Djillali Annane 4 , Clémence Marois 8 9 , Sophie Demeret 8 9 , Emmanuel Weiss 10 11 , Guillaume Voiriot 12 , Muriel Fartoukh 12 , Jean-Michel Constantin 1 , Bruno Mégarbane 13 , Gaëtan Plantefève 14 , Hélène Boucher-Pillet 15 , Guillaume Churlaud 15 , Audrey Cras 3 16 , Camille Maheux 15 , Chloé Pezzana 17 , Mamadou Hassimiou Diallo 18 , Said Lebbah 18 , Jacques Ropers 18 , Joe-Elie Salem 19 , Christian Straus 20 , Philippe Menasché 16 21 , Jérôme Larghero 3 15 , Antoine Monsel 22 23 24 ; APHP STROMA–CoV‐2 Collaborative Research Group
Collaborators, Affiliations
- PMID: 38637891
- DOI: 10.1186/s13287-024-03729-w
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: Acute respiratory distress syndrome; Follow-up Studies; Long-term outcomes; Quality of Life at six and twelve months after hospital discharge; Severe acute respiratory syndrome coronavirus‐2; Umbilical cord‐ derived mesenchymal stromal cells.