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Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371601
Recruitment Status : Unknown
Verified March 2020 by Fuzhou General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital

Tracking Information
First Submitted Date  ICMJE March 25, 2020
First Posted Date  ICMJE May 1, 2020
Last Update Posted Date May 1, 2020
Actual Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
Changes of oxygenation index (PaO2/FiO2) ,blood gas test [ Time Frame: 12 months ]
Improvement of pulmonary function
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • Detection of TNF-α levels, IL-10 levels [ Time Frame: 1,3,6,12months ]
    Cytokines level
  • Detection of immune cells that secret cytokines, including CXCR3+, CD4+, CD8+, NK+ cells, and regulatory T cells (CD4 + CD25 + FOXP3 + Treg cells). [ Time Frame: 1,3,6,12months ]
    Immunological status
  • Changes of oxygenation index (PaO2/FiO2) ,blood gas test [ Time Frame: 1,3,6months ]
    Improvement of pulmonary function
  • Changes of c-reactive protein and calcitonin [ Time Frame: 1,3,6,12months ]
    Infection biomarkers
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019
Official Title  ICMJE Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019
Brief Summary

The outbreak of coronavirus disease 2019 (COVID-19) at the end of 2019 has seen numerous patients experiencing severe acute lung injury (ALI), which developed into severe respiratory distress syndrome (ARDS). The mortality was as high as 20% -40%. Due to the lack of effective antiviral treatments, supporting treatment is the predominant therapy for COVID-19 pneumonia. Its cure is essentially dependent on the patient's immunity. While the immune system eliminates the virus, numerous inflammatory cytokines are produced and a cytokine storm occurs in severe cases.

Mesenchymal stem cells (MSCs) play an important role in injury repair and immune regulation, showing advantageous prospects in the treatment of COVID-19 pneumonia. MSCs prevent cytokine storms by retarding the TNF-α pathway, alleviate sepsis by modulating macrophages, neutrophils, NK cells, DC cells, T lymphocytes and B lymphocytes. After infused, MSCs aggregate in the lungs, improve the lung microenvironment, protect alveolar epithelia, and improve pulmonary fibrosis and pulmonary function.

Detailed Description

In vitro, Mesenchymal stem cells were revealed to inhibit the secretion of inflammatory cytokines by spleen lymphocytes and up-regulate regulatory T cells, thereby inhibiting the secretion of interferon-γ(IFN-γ) induced by lymphocytes and Tumor Necrosis Factor(TNF) induced by macrophage.

Animal models and preclinical studies have shown that mesenchymal stem cells (MSCs) were implanted into inflammatory lung tissues after infusion, which significantly improved the clinical manifestations and histopathological lesions caused by acute lung injury. Mesenchymal stem cells inhibited the effects of interleukin-1 (IL-1) through regulatory T cells (CD4 + CD25 + FOXP3 + Treg cells) and by antagonizing the expression interleukin-1 receptor (IL1-RA). Mesenchymal stem cells significantly down-regulated pro-inflammatory factors by inhibiting the expression of IL-1, TNF and IFN-γ in lung tissue, and up-regulated anti-inflammatory factor by enhancing the expression of IL -10 and regulatory T cells, respectively, thereby dampening the inflammatory response.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Control group: conventional symptomatic treatments such as antiviral (oseltamivir), hormones, oxygen therapy, mechanical ventilation and other supportive therapies; Experimental group: On the basis of the above-mentioned conventional symptomatic treatment and supportive therapy, umbilical cord mesenchymal stem cells were given at 106 / Kg body weight / time, once every 4 days for a total of 4 times. Peripheral intravenous infusion was given within 3 days of first admission.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE
  • Drug: Oseltamivir
    Oseltamivir capsules
  • Drug: hormones
    a moderate amount of hormone
  • Device: oxygen therapy
    oxygen therapy,mechanical ventilation and other supportive therapies
  • Procedure: mesenchymal stem cells
    mesenchymal stem cells
Study Arms  ICMJE
  • Active Comparator: Control group
    conventional symptomatic treatments such as antiviral (oseltamivir), hormones, oxygen therapy, mechanical ventilation and other supportive therapies
    Interventions:
    • Drug: Oseltamivir
    • Drug: hormones
    • Device: oxygen therapy
  • Experimental: Experimental group
    On the basis of the above-mentioned conventional symptomatic treatment and supportive therapy, umbilical cord mesenchymal stem cells were given at 106/Kg body weight / time, once every 4 days for a total of 4 times. Peripheral intravenous infusion was given within 3 days of first admission
    Interventions:
    • Drug: Oseltamivir
    • Drug: hormones
    • Device: oxygen therapy
    • Procedure: mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 30, 2020)
60
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with severe COVID-19 pneumonia
  • willing to give informed consent

Exclusion Criteria:

  • patients with mild COVID-19 pneumonia
  • liver dysfunction
  • concomitant with other active infection
  • renal dysfunction
  • Heart failure >grade 2
  • pregnant
  • history of COPD
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04371601
Other Study ID Numbers  ICMJE MSC-CoViD-2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fuzhou General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fuzhou General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jianming Tan Tan, M.D and Ph.D Fuzhou General Hospital
PRS Account Fuzhou General Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP