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| Name | Class |
|---|---|
| Tuohua Biological Technology Co. Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pneumonia | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-MSCs | Biological | After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7. |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation index | partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2) | on the day 14 after enrollment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XingHuan Wang, professor | Contact | 18971387168 | znyylcsy@126.com | |
| ZhiYong Peng, professor | Contact | 18672396028 | pengzy5@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| XingHuan Wang, professor | Wuhan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D053717 | Pneumonia, Ventilator-Associated |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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reaching the criteria of pneumonia according to Diagnosis and Clinical Management of Pneumonia caused by 2019-nCoV Infection(Trial Version 4)
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| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |