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Clinical Trial
. 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
Clinical Trial

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 et al. Stem Cell Res Ther. .

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: 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.

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Conflict of interest statement

AD declared grants or contracts from Philips, Fisher & Paykel; French Ministry of Health; Respinor; Lungspacer; consulting fees from Lungspacer, Respinor; payments or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from Fisher & Paykel, Getinge, Lungspacer, Gilead, Lowenstein, Astra; support for attending meetings and/or travel from Fisher & Paykel, Lungspacer; received equipment, materials, drugs, medical writing, gifts or other services from Lungspacer, Respinor. MF declared grants or contracts from BioMérieux and MSD; French Ministry of Health; consulting fees from Pfizer; payments or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from Fisher & Paykel and Biomérieux; participation on a data safety monitoring board or advisory board. No conflict of interests is reported for other authors.

Figures

Fig. 1
Fig. 1
Flow chart of the trial. ELS extracorporeal life support. UC-MSCs umbilical cord-derived mesenchymal stromal cells
Fig. 2
Fig. 2
Comparative analysis of patient-reported outcomes using the medical outcome study 36-item short form survey and the EuroQol 5 dimension 5 level dimensions at 6 and 12 months. A UC-MSCs versus placebo groups are visualized as radar chart. Each of the eight domains is scored on a scale from 0 to 100, with a higher score indicating better health and less impact of health on usual roles. In this radar chart, the central point represents a score of 0, while the outermost boundary corresponds to a score of 100. B and C Bar chart representation depicting the EQ-5D variables at 6 months (B) and at 12 months (C). At the 6-month assessment, 11 patients from the UC-MSCs group and 13 from the placebo group were evaluated (24 patients in global cohort). At the 12-month mark, 7 patients from the UC-MSCs group and 12 from the placebo group were assessed (19 patients in global cohort). EQ-5D EuroQol 5 Dimension 5 Level. M month. UC-MSCs umbilical cord-derived mesenchymal stromal cells. SF-36 36-Item Short Form Survey
See this image and copyright information in PMC

References

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