Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia

Study Overview
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Brief Summary
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Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia.

Detailed Description
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Serious Pneumonia and Critical Pneumonia caused by the 2019-nCOV infection greatly threats patients' life, UC-MSCs treatment has been proved to play a role in curing multiple diseases. And this study is conducted to find out whether or not it will function in 2019-nCOV infection Pneumonia. And we are going to get the permission of the enrolled patients. Besides the present clinical treatment, UC-MSCs treatment will be applied to those fulfilling the enrollment. After a period of UC-MSCs treatment, the analysis of UC-MSCs treatment will be completed from related aspects.

Official Title
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Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection

Conditions
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Pneumonia, Viral, Pneumonia, Ventilator-Associated

Intervention / Treatment
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* Biological: UC-MSCs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old ,no gender restriction According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV infection(Trial Version 6), patients are diagnosed with severe or critical 2019-nCoV pneumonia Women of childbearing age should have a negative blood pregnancy test before the start of dosing and agree to take effective contraceptive measures during the trial until the last follow-up (28 days) Previous detection of Nucleotide or antibody of 2019-nCoV pneumonia was positive Voluntarily participate in this clinical study and sign a written informed consent. If the patient cannot obtain informed consent, he can authorize his legal representative. Exclusion Criteria: Liver SOFA score of more than 3 points; HIV positive Highly allergic constitution or history of severe allergies; Pregnant and lactating women; Patients with malignant tumors; Patients with previous history of pulmonary embolism; Participating in clinical trials of other drugs within 3 months before enrollment. be thought by researchers to be inappropriate to participate in this clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: reaching the criteria of pneumonia according to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pneumonia<br>According to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4), patients enrolled will be divided to serious pneumonia group or critical pneumonia group. All subjects will receive UC-MSCs 3.3 * 107 cell number / 50ml / bag, 3 bags each time. And UC-MSCs will be infused intravenously on the 1st, 3rd, 5th, and 7th days after enrollment, 1 time each day. The efficacy and safety of the treatment, patients' adverse reactions will be monitored. | Biological: UC-MSCs<br>* After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation index | partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2) | on the day 14 after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day mortality | whether the patient survives | on the day 28 after enrollment | 
| Hospital stay | days of the patients in hospital | up to 6 months | 
| 2019-nCoV antibody test | whether or not the 2019-nCoV antibody is positive | on the day 7,14,28 after enrollment | 
| 2019-nCoV nucleic acid test | whether or not the 2019-nCoV nucleic acid test is positive | on the day 7,14,28 after enrollment | 
| Improvement of lung imaging examinations | whether lung imaging examinations show the improvement of the pneumonia | on the day 7,14,28 after enrollment | 
| White blood cell count | counts of white blood cell in a litre of blood | on the day 7,14,28 after enrollment | 
| Lymphocyte count | counts of lymphocyte in a litre (L) of blood | on the day 7,14,28 after enrollment | 
| Procalcitonin | procalcitonin in microgram(ug)/L | on the day 7,14,28 after enrollment | 
| interleukin(IL)-2 | IL-2 in picogram(pg)/millilitre(mL) | on the day 7,14,28 after enrollment | 
| IL-4 | IL-4 in pg/mL | on the day 7,14,28 after enrollment | 
| IL-6 | IL-6 in pg/mL | on the day 7,14,28 after enrollment | 
| IL-10 | IL-10 in pg/mL | on the day 7,14,28 after enrollment | 
| tumor necrosis factor(TNF)-α | TNF-α in nanogram(ng)/L | on the day 7,14,28 after enrollment | 
| γ-interferon(IFN) | γ-IFN in a thousand unit (KU)/L | on the day 7,14,28 after enrollment | 
| C-reactive protein(CRP) | CRP in microgram（μg）/L | on the day 7,14,28 after enrollment | 
| CD4+ T-Lymphocytopenia | counts of CD4+ T-Lymphocytopenia in litre | on the day 7,14,28 after enrollment | 
| CD8+ T-Lymphocytopenia | counts of CD8+ T-Lymphocytopenia in a litre | on the day 7,14,28 after enrollment | 
| natural killer cell(NK) | counts of NK in a litre | on the day 7,14,28 after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2019-nCOV infection, UC-MSCs Treatment