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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 : Active, not recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Oseltamivir Drug: hormones Device: oxygen therapy Procedure: mesenchymal stem cells Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Official Title: Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oseltamivir

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control group
conventional symptomatic treatments such as antiviral (oseltamivir), hormones, oxygen therapy, mechanical ventilation and other supportive therapies
 Drug: Oseltamivir
Oseltamivir capsules

Drug: hormones
a moderate amount of hormone

Device: oxygen therapy
oxygen therapy,mechanical ventilation and other supportive therapies
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Changes of oxygenation index (PaO2/FiO2) ,blood gas test [ Time Frame: 12 months ]
    Improvement of pulmonary function


Secondary Outcome Measures :
  1. Detection of TNF-α levels, IL-10 levels [ Time Frame: 1,3,6,12months ]
    Cytokines level

  2. 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

  3. Changes of oxygenation index (PaO2/FiO2) ,blood gas test [ Time Frame: 1,3,6months ]
    Improvement of pulmonary function

  4. Changes of c-reactive protein and calcitonin [ Time Frame: 1,3,6,12months ]
    Infection biomarkers


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371601


Locations
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China, Fujian
Fuzhou General Hospital
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
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Study Chair: Jianming Tan Tan, M.D and Ph.D Fuzhou General Hospital
More Information
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Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT04371601    
Other Study ID Numbers: MSC-CoViD-2020
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Oseltamivir
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action