tetano
Editor, Senior Moderator
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[SUP] 1 [/SUP], Caroline Hauw-Berlemont[SUP] 2 [/SUP], Miryam Mebarki[SUP] 3 [/SUP], Nicholas Heming[SUP] 4 [/SUP], Julien Mayaux[SUP] 5 [/SUP], Jean-Luc Diehl[SUP] 2 6 7 [/SUP], Alexandre Demoule[SUP] 5 [/SUP], Djillali Annane[SUP] 4 [/SUP], Clémence Marois[SUP] 8 9 [/SUP], Sophie Demeret[SUP] 8 9 [/SUP], Emmanuel Weiss[SUP] 10 11 [/SUP], Guillaume Voiriot[SUP] 12 [/SUP], Muriel Fartoukh[SUP] 12 [/SUP], Jean-Michel Constantin[SUP] 1 [/SUP], Bruno Mégarbane[SUP] 13 [/SUP], Gaëtan Plantefève[SUP] 14 [/SUP], Hélène Boucher-Pillet[SUP] 15 [/SUP], Guillaume Churlaud[SUP] 15 [/SUP], Audrey Cras[SUP] 3 16 [/SUP], Camille Maheux[SUP] 15 [/SUP], Chloé Pezzana[SUP] 17 [/SUP], Mamadou Hassimiou Diallo[SUP] 18 [/SUP], Said Lebbah[SUP] 18 [/SUP], Jacques Ropers[SUP] 18 [/SUP], Joe-Elie Salem[SUP] 19 [/SUP], Christian Straus[SUP] 20 [/SUP], Philippe Menasché[SUP] 16 21 [/SUP], Jérôme Larghero[SUP] 3 15 [/SUP], Antoine Monsel[SUP] 22 23 24 [/SUP]; 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[SUP] 1 [/SUP], Caroline Hauw-Berlemont[SUP] 2 [/SUP], Miryam Mebarki[SUP] 3 [/SUP], Nicholas Heming[SUP] 4 [/SUP], Julien Mayaux[SUP] 5 [/SUP], Jean-Luc Diehl[SUP] 2 6 7 [/SUP], Alexandre Demoule[SUP] 5 [/SUP], Djillali Annane[SUP] 4 [/SUP], Clémence Marois[SUP] 8 9 [/SUP], Sophie Demeret[SUP] 8 9 [/SUP], Emmanuel Weiss[SUP] 10 11 [/SUP], Guillaume Voiriot[SUP] 12 [/SUP], Muriel Fartoukh[SUP] 12 [/SUP], Jean-Michel Constantin[SUP] 1 [/SUP], Bruno Mégarbane[SUP] 13 [/SUP], Gaëtan Plantefève[SUP] 14 [/SUP], Hélène Boucher-Pillet[SUP] 15 [/SUP], Guillaume Churlaud[SUP] 15 [/SUP], Audrey Cras[SUP] 3 16 [/SUP], Camille Maheux[SUP] 15 [/SUP], Chloé Pezzana[SUP] 17 [/SUP], Mamadou Hassimiou Diallo[SUP] 18 [/SUP], Said Lebbah[SUP] 18 [/SUP], Jacques Ropers[SUP] 18 [/SUP], Joe-Elie Salem[SUP] 19 [/SUP], Christian Straus[SUP] 20 [/SUP], Philippe Menasché[SUP] 16 21 [/SUP], Jérôme Larghero[SUP] 3 15 [/SUP], Antoine Monsel[SUP] 22 23 24 [/SUP]; 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.