Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019
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ClinicalTrials.gov Identifier: NCT04371601 |
Recruitment Status :
Active, not recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
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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 |
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 : | 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 |

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 |
- Changes of oxygenation index (PaO2/FiO2) ,blood gas test [ Time Frame: 12 months ]Improvement of pulmonary function
- 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

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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 |
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

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
China, Fujian | |
Fuzhou General Hospital | |
Fuzhou, Fujian, China, 350025 |
Study Chair: | Jianming Tan Tan, M.D and Ph.D | Fuzhou General Hospital |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia COVID-19 Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Virus Diseases Pneumonia, Viral Oseltamivir Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |