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10.1002/sctm.20-0472

http://scihub22266oqcxt.onion/10.1002/sctm.20-0472
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33400390!8046040!33400390
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suck abstract from ncbi


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pmid33400390      Stem+Cells+Transl+Med 2021 ; 10 (5): 660-673
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  • Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial #MMPMID33400390
  • Lanzoni G; Linetsky E; Correa D; Messinger Cayetano S; Alvarez RA; Kouroupis D; Alvarez Gil A; Poggioli R; Ruiz P; Marttos AC; Hirani K; Bell CA; Kusack H; Rafkin L; Baidal D; Pastewski A; Gawri K; Lenero C; Mantero AMA; Metalonis SW; Wang X; Roque L; Masters B; Kenyon NS; Ginzburg E; Xu X; Tan J; Caplan AI; Glassberg MK; Alejandro R; Ricordi C
  • Stem Cells Transl Med 2021[May]; 10 (5): 660-673 PMID33400390show ga
  • Acute respiratory distress syndrome (ARDS) in COVID-19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti-inflammatory effects and could yield beneficial effects in COVID-19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC-MSC) infusions in subjects with COVID-19 ARDS. A double-blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty-four subjects were randomized 1:1 to either UC-MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC-MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 +/- 20 x 10(6) UC-MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion-associated AEs. No serious adverse events (SAEs) were observed related to UC-MSC infusions. UC-MSC infusions in COVID-19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC-MSC-treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE-free survival (P = .008), and time to recovery (P = .03). UC-MSC infusions are safe and could be beneficial in treating subjects with COVID-19 ARDS.
  • |Anti-Inflammatory Agents/*therapeutic use[MESH]
  • |COVID-19/*therapy[MESH]
  • |Cytokines/blood[MESH]
  • |Double-Blind Method[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Mesenchymal Stem Cell Transplantation/adverse effects/*methods[MESH]
  • |Mesenchymal Stem Cells[MESH]
  • |Middle Aged[MESH]
  • |SARS-CoV-2/drug effects[MESH]
  • |Severity of Illness Index[MESH]
  • |Treatment Outcome[MESH]


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