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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.
Lanzoni, Giacomo; Linetsky, Elina; Correa, Diego; Messinger Cayetano, Shari; Alvarez, Roger A; Kouroupis, Dimitrios; Alvarez Gil, Ana; Poggioli, Raffaella; Ruiz, Phillip; Marttos, Antonio C; Hirani, Khemraj; Bell, Crystal A; Kusack, Halina; Rafkin, Lisa; Baidal, David; Pastewski, Andrew; Gawri, Kunal; Leñero, Clarissa; Mantero, Alejandro M A; Metalonis, Sarah W; Wang, Xiaojing; Roque, Luis; Masters, Burlett; Kenyon, Norma S; Ginzburg, Enrique; Xu, Xiumin; Tan, Jianming; Caplan, Arnold I; Glassberg, Marilyn K; Alejandro, Rodolfo; Ricordi, Camillo.
  • Lanzoni G; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Linetsky E; Department of Biochemistry and Molecular Biology, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Correa D; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Messinger Cayetano S; Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Alvarez RA; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Kouroupis D; Department of Orthopedics, UHealth Sports Medicine Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Alvarez Gil A; Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Poggioli R; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Ruiz P; University of Miami Health System, Miami, Florida, USA.
  • Marttos AC; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Hirani K; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Bell CA; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Kusack H; Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Rafkin L; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Baidal D; University of Miami Health System, Miami, Florida, USA.
  • Pastewski A; Jackson Health System, Miami, Florida, USA.
  • Gawri K; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Leñero C; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Mantero AMA; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Metalonis SW; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Wang X; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Roque L; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Masters B; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Kenyon NS; University of Miami Health System, Miami, Florida, USA.
  • Ginzburg E; Jackson Health System, Miami, Florida, USA.
  • Xu X; Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Tan J; University of Miami Health System, Miami, Florida, USA.
  • Caplan AI; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Glassberg MK; Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Alejandro R; Division of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.
  • Ricordi C; Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Stem Cells Transl Med ; 10(5): 660-673, 2021 05.
Article in English | MEDLINE | ID: covidwho-1008163
Semantic information from SemMedBD (by NLM)
1. Respiratory Distress Syndrom COEXISTS_WITH C5203670
Subject
Respiratory Distress Syndrom
Predicate
COEXISTS_WITH
Object
C5203670
2. Immunoregulation ASSOCIATED_WITH Acute respiratory distress syndrome due to disease caused by Severe acute respiratory syndrome coronavirus 2
Subject
Immunoregulation
Predicate
ASSOCIATED_WITH
Object
Acute respiratory distress syndrome due to disease caused by Severe acute respiratory syndrome coronavirus 2
3. Intravenous infusion procedures ADMINISTERED_TO Treatment Group
Subject
Intravenous infusion procedures
Predicate
ADMINISTERED_TO
Object
Treatment Group
4. Respiratory Distress Syndrome, Adult COEXISTS_WITH COVID-19
Subject
Respiratory Distress Syndrome, Adult
Predicate
COEXISTS_WITH
Object
COVID-19
5. Immunoregulation ASSOCIATED_WITH Acute respiratory distress syndrome due to disease caused by Severe acute respiratory syndrome coronavirus 2
Subject
Immunoregulation
Predicate
ASSOCIATED_WITH
Object
Acute respiratory distress syndrome due to disease caused by Severe acute respiratory syndrome coronavirus 2
6. Intravenous infusion procedures ADMINISTERED_TO Treatment Group
Subject
Intravenous infusion procedures
Predicate
ADMINISTERED_TO
Object
Treatment Group
ABSTRACT
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 11 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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Mesenchymal Stem Cell Transplantation / COVID-19 / Anti-Inflammatory Agents Type of study: Controlled clinical trial / Observational study / Randomized controlled trials Limits: Female / Humans / Male / Middle aged Language: English Journal: Stem Cells Transl Med Year: 2021 Document Type: Article Affiliation country: Sctm.20-0472

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Mesenchymal Stem Cell Transplantation / COVID-19 / Anti-Inflammatory Agents Type of study: Controlled clinical trial / Observational study / Randomized controlled trials Limits: Female / Humans / Male / Middle aged Language: English Journal: Stem Cells Transl Med Year: 2021 Document Type: Article Affiliation country: Sctm.20-0472