| Autor: |
Cécile Pochon, Caroline Laroye, Antoine Kimmoun, Loic Reppel, Adéle Dhuyser, Hélène Rousseau, Mélanie Gauthier, Nadine Petitpain, Jean-François Chabot, Simon Valentin, Marcelo de Carvalho Bittencourt, Michael Peres, Alice Aarnink, Véronique Decot, Danièle Bensoussan, Sébastien Gibot |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
Frontiers in Medicine, Vol 10 (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2296-858X |
| DOI: |
10.3389/fmed.2023.1224865 |
| Popis: |
BackgroundThe 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.MethodsIn 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 × 106 WJ-MSCs/kg or placebo within 48 h of invasive ventilation followed by 2 infusions of 0.5 × 106 WJ-MSCs/kg or placebo over 5 days. The primary endpoint was the percentage of patients with a PaO2/FiO2 > 200 on day 10.ResultsThirty 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 PaO2/FiO2 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.ConclusionWhile 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 registrationhttps://beta.clinicaltrials.gov/study/NCT04625738, identifier NCT04625738. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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