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

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 effi...

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Veröffentlicht in:Stem cells translational medicine Jg. 10; H. 5; S. 660 - 673
Hauptverfasser: 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
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Hoboken, USA John Wiley & Sons, Inc 01.05.2021
Oxford University Press
Schlagworte:
Acute respiratory distress syndrome
Adverse events
Anti-Inflammatory Agents - therapeutic use
Care and treatment
cell transplantation
cellular therapy
Chemokines
Clinical outcomes
Clinical trials
Coronaviruses
COVID-19
COVID-19 - therapy
Cytokine storm
Cytokines
Cytokines - blood
Design
Disease
Double-Blind Method
Double-blind studies
Ethylenediaminetetraacetic acid
Female
Growth factors
Hospitalization
Human Clinical
Humans
Immunomodulation
Inflammation
Intravenous administration
Laboratories
Male
Manufacturing
Mesenchymal Stem Cell Transplantation - adverse effects
Mesenchymal Stem Cell Transplantation - methods
Mesenchymal Stem Cells
Middle Aged
Mortality
Patients
Plasma
Respiratory distress syndrome
respiratory tract
SARS-CoV-2 - drug effects
Severe acute respiratory syndrome coronavirus 2
Severity of Illness Index
Stem cells
transplantation
Treatment Outcome
Tumor necrosis factor-TNF
Umbilical cord
Umbilical Cord - cytology
United Kingdom
cell transplantation
mesenchymal stem cells
respiratory tract
transplantation
clinical trials
cellular therapy
umbilical cord
ISSN:2157-6564, 2157-6580, 2157-6580
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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 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.
AbstractList 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 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.
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.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.
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.
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 × 10[sup.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.
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 × 10 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.
Audience Academic
Author Baidal, David
Masters, Burlett
Roque, Luis
Bell, Crystal A.
Mantero, Alejandro M. A.
Messinger Cayetano, Shari
Leñero, Clarissa
Gawri, Kunal
Kusack, Halina
Glassberg, Marilyn K.
Metalonis, Sarah W.
Marttos, Antonio C.
Tan, Jianming
Kouroupis, Dimitrios
Alvarez Gil, Ana
Correa, Diego
Poggioli, Raffaella
Hirani, Khemraj
Rafkin, Lisa
Kenyon, Norma S.
Alvarez, Roger A.
Linetsky, Elina
Ruiz, Phillip
Ricordi, Camillo
Xu, Xiumin
Wang, Xiaojing
Ginzburg, Enrique
Pastewski, Andrew
Caplan, Arnold I.
Alejandro, Rodolfo
Lanzoni, Giacomo
AuthorAffiliation 4 Department of Orthopedics, UHealth Sports Medicine Institute University of Miami Miller School of Medicine Miami Florida USA
9 The Second Affiliated Hospital of Hainan Medical University Haikou Hainan People's Republic of China
5 Division of Biostatistics, Department of Public Health Sciences University of Miami Miller School of Medicine Miami Florida USA
7 University of Miami Health System Miami Florida USA
6 Department of Medicine University of Miami Miller School of Medicine Miami Florida USA
1 Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine Miami Florida USA
3 Department of Surgery University of Miami Miller School of Medicine Miami Florida USA
2 Department of Biochemistry and Molecular Biology University of Miami Miller School of Medicine Miami Florida USA
10 Skeletal Research Center Case Western Reserve University Cleveland Ohio USA
8 Jackson Health System Miami Florida USA
11 University of Arizona College of Medicine Tucson Arizona USA
AuthorAffiliation_xml – name: 11 University of Arizona College of Medicine Tucson Arizona USA
– name: 1 Diabetes Research Institute, Cell Transplant Center University of Miami Miller School of Medicine Miami Florida USA
– name: 6 Department of Medicine University of Miami Miller School of Medicine Miami Florida USA
– name: 5 Division of Biostatistics, Department of Public Health Sciences University of Miami Miller School of Medicine Miami Florida USA
– name: 7 University of Miami Health System Miami Florida USA
– name: 3 Department of Surgery University of Miami Miller School of Medicine Miami Florida USA
– name: 8 Jackson Health System Miami Florida USA
– name: 4 Department of Orthopedics, UHealth Sports Medicine Institute University of Miami Miller School of Medicine Miami Florida USA
– name: 10 Skeletal Research Center Case Western Reserve University Cleveland Ohio USA
– name: 9 The Second Affiliated Hospital of Hainan Medical University Haikou Hainan People's Republic of China
– name: 2 Department of Biochemistry and Molecular Biology University of Miami Miller School of Medicine Miami Florida USA
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  surname: Lanzoni
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  organization: University of Miami Miller School of Medicine
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  organization: University of Miami Miller School of Medicine
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  organization: University of Miami Miller School of Medicine
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  givenname: Shari
  surname: Messinger Cayetano
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  organization: University of Miami Miller School of Medicine
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  givenname: Roger A.
  surname: Alvarez
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  organization: University of Miami Health System
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  surname: Kouroupis
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  organization: University of Miami Miller School of Medicine
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  surname: Alvarez Gil
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  organization: University of Miami Miller School of Medicine
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  surname: Poggioli
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  organization: University of Miami Miller School of Medicine
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  surname: Ruiz
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  organization: University of Miami Miller School of Medicine
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  surname: Marttos
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  organization: Jackson Health System
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  surname: Hirani
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  organization: University of Miami Miller School of Medicine
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  organization: University of Miami Miller School of Medicine
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  organization: University of Miami Miller School of Medicine
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  givenname: Alejandro M. A.
  surname: Mantero
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  organization: University of Miami Miller School of Medicine
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  organization: University of Miami Miller School of Medicine
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  organization: University of Miami Miller School of Medicine
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  organization: University of Miami Miller School of Medicine
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  givenname: Jianming
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  organization: The Second Affiliated Hospital of Hainan Medical University
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  email: ricordi@miami.edu
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/33400390$$D View this record in MEDLINE/PubMed
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Copyright 2021 The Authors. published by Wiley Periodicals LLC on behalf of AlphaMed Press
2021 The Authors. STEM CELLS TRANSLATIONAL MEDICINE published by Wiley Periodicals LLC on behalf of AlphaMed Press.
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Keywords cell transplantation
mesenchymal stem cells
respiratory tract
transplantation
clinical trials
cellular therapy
umbilical cord
Language English
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2021 The Authors. STEM CELLS TRANSLATIONAL MEDICINE published by Wiley Periodicals LLC on behalf of AlphaMed Press.
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National Center for Advancing Translational Sciences, Grant/Award Numbers: UL1TR002736, UL1TR000460; Ugo Colombo; Simkins Family Foundation; Fondazione Silvio Tronchetti Provera; Barilla Group and Family; Diabetes Research Institute Foundation (DRIF); The Cure Alliance; North America's Building Trades Unions (NABTU)
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Snippet Acute respiratory distress syndrome (ARDS) in COVID‐19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and...
Acute respiratory distress syndrome (ARDS) in COVID-19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and...
Abstract Acute respiratory distress syndrome (ARDS) in COVID‐19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory...
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SubjectTerms Acute respiratory distress syndrome
Adverse events
Anti-Inflammatory Agents - therapeutic use
Care and treatment
cell transplantation
cellular therapy
Chemokines
Clinical outcomes
Clinical trials
Coronaviruses
COVID-19
COVID-19 - therapy
Cytokine storm
Cytokines
Cytokines - blood
Design
Disease
Double-Blind Method
Double-blind studies
Ethylenediaminetetraacetic acid
Female
Growth factors
Hospitalization
Human Clinical
Humans
Immunomodulation
Inflammation
Intravenous administration
Laboratories
Male
Manufacturing
Mesenchymal Stem Cell Transplantation - adverse effects
Mesenchymal Stem Cell Transplantation - methods
Mesenchymal Stem Cells
Middle Aged
Mortality
Patients
Plasma
Respiratory distress syndrome
respiratory tract
SARS-CoV-2 - drug effects
Severe acute respiratory syndrome coronavirus 2
Severity of Illness Index
Stem cells
transplantation
Treatment Outcome
Tumor necrosis factor-TNF
Umbilical cord
Umbilical Cord - cytology
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Title 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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