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

被引：2

作者：

Sitbon, Alexandre ^{[1
]}

Hauw-Berlemont, Caroline ^{[2
]}

Mebarki, Miryam ^{[3
]}

Heming, Nicholas ^{[4
]}

Mayaux, Julien ^{[5
]}

Diehl, Jean-Luc ^{[2
,6
,7
]}

Demoule, Alexandre ^{[5
]}

Annane, Djillali ^{[4
]}

Marois, Clemence ^{[8
,9
]}

Demeret, Sophie ^{[8
,9
]}

Weiss, Emmanuel ^{[10
,11
]}

Voiriot, Guillaume ^{[12
]}

Fartoukh, Muriel ^{[12
]}

Constantin, Jean-Michel ^{[1
]}

Megarbane, Bruno ^{[13
]}

Plantefeve, Gaetan ^{[14
]}

Boucher-Pillet, Helene ^{[15
]}

Churlaud, Guillaume ^{[15
]}

Cras, Audrey ^{[3
,16
]}

Maheux, Camille ^{[15
]}

Pezzana, Chloe ^{[17
]}

Diallo, Mamadou Hassimiou ^{[18
]}

Lebbah, Said ^{[18
]}

Ropers, Jacques ^{[18
]}

Salem, Joe-Elie ^{[19
]}

Straus, Christian ^{[20
,21
]}

Menasche, Philippe

Larghero, Jerome ^{[3
,15
]}

Monsel, Antoine ^{[1
,22
,23
]}

机构：

[1] Sorbonne Univ, La Pitie Salpetriere Hop, AP HP, Multidisciplinary Intens Care Unit,Dept Anesthesi, 47-83 Blvd Hop, F-75651 Paris 13, France

[2] Univ Paris Cite, Hop Europeen Georges Pompidou, APHP CUP, Intens Care Unit, F-75015 Paris, France

[3] Univ Paris Cite, Hosp St Louis, AP HP,CBT501, INSERM,Unite Therapie Cellulaire,Ctr Invest Clin, Paris, France

[4] Univ Versailles St Quentin Univ Paris Saclay, Hop Raymond Poincare AP HP, FHU SEPSIS,Dept Intens Care, Simone Veil Sch Med,Lab Infect & Inflammat INSERM, F-92380 Garches, France

[5] Sorbonne Univ, Grp Hosp Univ, AP HP,Site Pitie Salpetriere,INSERM,UMRS1158 Neur, Serv Medecine Intens & Reanimat Departement R3S, Paris, France

[6] Univ Paris Cite, INSERM, Innovat Therapies Hemostasis, F-75006 Paris, France

[7] Hop Europeen Georges Pompidou, Carpentier Fdn, AP HP CUP, Biosurg Res Lab, F-75015 Paris, France

[8] Sorbonne Univ, La Pitie Salpetriere Hosp, AP HP, Neurol Intens Care Unit,Dept Neurol, Paris, France

[9] Sorbonne Univ, Grp Rech Clin REanimat & Soins Intens Patient Ins, Paris, France

[10] Beaujon Hosp, APHP Nord, Dept Anesthesiol & Crit Care, DMU PARABOL, Paris, France

[11] Univ Paris Cite, Ctr Res Inflammat, INSERM, Paris, France

[12] Sorbonne Univ, Hop Tenon, Serv Med Intens Reanimat, Ctr Rech St Antoine,UMRS 938,INSERM,AP HP, Paris, France

[13] Univ Paris, Lariboisiere Hosp, Dept Med & Toxicol Crit Care, INSERM UMRS1144, Paris, France

[14] Ctr Hosp Victor Dupouy, Serv Reanimat Polyvalente, 69 Rue Lieutenant Colonel Prudhon, F-95100 Argenteuil, France

[15] Hop St Louis, AP HP, Ctr MEARY Therapie Cellulaire & Genique, Paris, France

[16] Univ Paris Cite, INSERM UMR1140, F-75006 Paris, France

[17] Univ Paris, Paris Ctr Rech Cardiovasc PARCC, INSERM, UMR S 970, Paris, France

[18] Pitie Salpetriere Univ Hosp, AP HP, Clin Res Unit, Paris, France

[19] Sorbonne Univ, Pitie Salpetriere Hosp, Clin Invest Ctr CIC 1901,Inst Natl Sante & Rech M, INSERM,Reg Pharmacovigilance Ctr,Dept Pharmacol, Paris, France

[20] INSERM, UMRS1158, Neurophysiol Resp Expt & Clin, F-75013 Paris, France

[21] Sorbonne Univ, APHP Grp Hosp Univ APHP Sorbonne Univ, Site PitieSalpetriere Dept R3S Respirat Reanimat, Serv Explorat Fonct nelles Resp Exercice & Dyspne, F-75013 Paris, France

[22] Sorbonne Univ, INSERM UMRS 959, Immunol Immunopathol Immunotherapy I3, F-75013 Paris, France

[23] Hop La Pitie Salpetriere, AP HP, Biotherapy CIC BTi, F-75651 Paris, France

来源：

STEM CELL RESEARCH & THERAPY | 2024年 / 15卷 / 01期

关键词：

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;

D O I：

10.1186/s13287-024-03729-w

中图分类号：

Q813 [细胞工程];

学科分类号：

摘要：

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.

引用

页数：9

共 16 条

[1] One-Year Outcomes of Mechanically Ventilated COVID-19 ICU Survivors: A Prospective Cohort Study [J].