Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial

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  • Giacomo Lanzoni
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Elina Linetsky
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Diego Correa
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Shari Messinger Cayetano
    Division of Biostatistics, Department of Public Health Sciences University of Miami Miller School of Medicine , Miami, Florida, USA
  • Roger A. Alvarez
    Department of Medicine University of Miami Miller School of Medicine , Miami, Florida, USA
  • Dimitrios Kouroupis
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Ana Alvarez Gil
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Raffaella Poggioli
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Phillip Ruiz
    Department of Surgery University of Miami Miller School of Medicine , Miami, Florida, USA
  • Antonio C. Marttos
    Department of Medicine University of Miami Miller School of Medicine , Miami, Florida, USA
  • Khemraj Hirani
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Crystal A. Bell
    Department of Medicine University of Miami Miller School of Medicine , Miami, Florida, USA
  • Halina Kusack
    Department of Medicine University of Miami Miller School of Medicine , Miami, Florida, USA
  • Lisa Rafkin
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • David Baidal
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Andrew Pastewski
    Jackson Health System , Miami, Florida, USA
  • Kunal Gawri
    Department of Medicine University of Miami Miller School of Medicine , Miami, Florida, USA
  • Clarissa Leñero
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Alejandro M. A. Mantero
    Division of Biostatistics, Department of Public Health Sciences University of Miami Miller School of Medicine , Miami, Florida, USA
  • Sarah W. Metalonis
    Division of Biostatistics, Department of Public Health Sciences University of Miami Miller School of Medicine , Miami, Florida, USA
  • Xiaojing Wang
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Luis Roque
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Burlett Masters
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Norma S. Kenyon
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Enrique Ginzburg
    Department of Surgery University of Miami Miller School of Medicine , Miami, Florida, USA
  • Xiumin Xu
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Jianming Tan
    The Second Affiliated Hospital of Hainan Medical University , Haikou, Hainan, People's Republic of China
  • Arnold I. Caplan
    Skeletal Research Center Case Western Reserve University , Cleveland, Ohio, USA
  • Marilyn K. Glassberg
    University of Arizona College of Medicine , Tucson, Arizona, USA
  • Rodolfo Alejandro
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA
  • Camillo Ricordi
    Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine , Miami, Florida, USA

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<jats:title>Abstract</jats:title> <jats:p>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 × 106 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.</jats:p>

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