Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019
NCT ID: NCT04371601
Last Updated: 2020-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
60 participants
INTERVENTIONAL
2020-03-01
2022-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
conventional symptomatic treatments such as antiviral (oseltamivir), hormones, oxygen therapy, mechanical ventilation and other supportive therapies
Oseltamivir
Oseltamivir capsules
hormones
a moderate amount of hormone
oxygen therapy
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
Oseltamivir
Oseltamivir capsules
hormones
a moderate amount of hormone
oxygen therapy
oxygen therapy,mechanical ventilation and other supportive therapies
mesenchymal stem cells
mesenchymal stem cells
Interventions
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Oseltamivir
Oseltamivir capsules
hormones
a moderate amount of hormone
oxygen therapy
oxygen therapy,mechanical ventilation and other supportive therapies
mesenchymal stem cells
mesenchymal stem cells
Eligibility Criteria
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Inclusion Criteria
* willing to give informed consent
Exclusion Criteria
* liver dysfunction
* concomitant with other active infection
* renal dysfunction
* Heart failure \>grade 2
* pregnant
* history of COPD
18 Years
70 Years
ALL
No
Sponsors
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Fuzhou General Hospital
OTHER
Responsible Party
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Principal Investigators
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Jianming Tan Tan, M.D and Ph.D
Role: STUDY_CHAIR
Fuzhou General Hospital
Locations
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Fuzhou General Hospital
Fuzhou, Fujian, China
Countries
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Other Identifiers
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MSC-CoViD-2020
Identifier Type: -
Identifier Source: org_study_id
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