دورية أكاديمية
Efficacy of Wharton Jelly Mesenchymal Stromal Cells infusions in moderate to severe SARS-Cov-2 related acute respiratory distress syndrome: a phase 2a double-blind randomized controlled trial
| العنوان: | Efficacy of Wharton Jelly Mesenchymal Stromal Cells infusions in moderate to severe SARS-Cov-2 related acute respiratory distress syndrome: a phase 2a double-blind randomized controlled trial |
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| المؤلفون: | Pochon, Cécile, Laroye, Caroline, Kimmoun, Antoine, Reppel, Loïc, Dhuyser, Adèle, Rousseau, Hélène, Gauthier, Mélanie, Petitpain, Nadine, Chabot, Jean-François, Valentin, Simon, de Carvalho-Bittencourt, Marcelo, Pérès, Michaël, Aarnink, Alice, Decot, Veronique, Bensoussan, Danièle, Gibot, Sébastien |
| المساهمون: | Ingénierie Moléculaire et Physiopathologie Articulaire (IMoPA), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Service d'Oncologie Pédiatrique CHRU Nancy, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Université de Lorraine (UL), Département Méthodologie Promotion Investigation CHRU Nancy (MPI), Centre Régional de PharmacoVigilance de Lorraine (CRPV Lorraine), Service de Pneumologie CHRU Nancy, This trial was funded by the Programme Hospitalier de Recherche Clinique supported by the French Ministry of Health. |
| المصدر: | ISSN: 2296-858X ; Frontiers in Medicine ; https://hal.univ-lorraine.fr/hal-04504413Test ; Frontiers in Medicine, 2023, 10 (2), pp.59. ⟨10.3389/fmed.2023.1224865⟩. |
| بيانات النشر: | HAL CCSD Frontiers media |
| سنة النشر: | 2023 |
| المجموعة: | Université de Lorraine: HAL |
| مصطلحات موضوعية: | ARDS COVID-19 mesenchymal stromal cells intensive care oxygenation Frontiers in Medicine 04 frontiersin.org, ARDS, COVID-19, mesenchymal stromal cells, intensive care, oxygenation Frontiers in Medicine 04 frontiersin.org, [SDV]Life Sciences [q-bio] |
| الوصف: | International audience ; Background The COVID-19 pandemic caused a wave of acute respiratory distress syndrome (ARDS) with a high in-hospital mortality, especially in patients requiring invasive mechanical ventilation. Wharton Jelly-derived Mesenchymal Stromal Cells (WJ-MSCs) may counteract the pulmonary damage induced by the SARS-CoV-2 infection through pro-angiogenic effects, lung epithelial cell protection, and immunomodulation. Methods In this randomized, double-blind, placebo-controlled phase 2a trial, adult patients receiving invasive mechanical ventilation for SARS-CoV-2 induced moderate or severe ARDS were assigned to receive 1 intravenous infusion of 1 × 10 6 WJ-MSCs/kg or placebo within 48 h of invasive ventilation followed by 2 infusions of 0.5 × 10 6 WJ-MSCs/kg or placebo over 5 days. The primary endpoint was the percentage of patients with a PaO 2 /FiO 2 > 200 on day 10. Results Thirty patients were included from November 2020 to May 2021, 15 in the WJ-MSC group and 15 in the placebo group. We did not find any significant difference in the PaO 2 /FiO 2 ratio at day 10, with 18 and 15% of WJ-MSCs and placebo-treated patients reaching a ratio >200, respectively. Survival did not differ in the 2 groups with a 20% mortality rate at day 90. While we observed a higher number of ventilation-free days at 28 days in the WJ-MSC arm, this difference was not statistically significant (median of 11 (0–22) vs. 0 (0–18), p = 0.2). The infusions were well tolerated, with a low incidence of anti-HLA alloimmunization after 90 days. Conclusion While treatment with WJ-MSCs appeared safe and feasible in patients with SARS-CoV2 moderate or severe ARDS in this phase 2a trial, the treatment was not associated with an increased percentage of patients with P/F > 200 at 10d, nor did 90 day mortality improve in the treated group. Clinical trial registration https://beta.clinicaltrials.gov/study/NCT04625738Test , identifier NCT04625738. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/37706025; hal-04504413; https://hal.univ-lorraine.fr/hal-04504413Test; https://hal.univ-lorraine.fr/hal-04504413/documentTest; https://hal.univ-lorraine.fr/hal-04504413/file/Pochon%20et%20al-2023-Frontiers.pdfTest; PUBMED: 37706025; PUBMEDCENTRAL: PMC10495568 |
| DOI: | 10.3389/fmed.2023.1224865 |
| الإتاحة: | https://doi.org/10.3389/fmed.2023.1224865Test https://hal.univ-lorraine.fr/hal-04504413Test https://hal.univ-lorraine.fr/hal-04504413/documentTest https://hal.univ-lorraine.fr/hal-04504413/file/Pochon%20et%20al-2023-Frontiers.pdfTest |
| حقوق: | info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.B278EF45 |
| قاعدة البيانات: | BASE |
| DOI: | 10.3389/fmed.2023.1224865 |
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