Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia
- Conditions
- Pneumonia, ViralPneumonia, Ventilator-Associated
- Interventions
- Biological: UC-MSCs
- Registration Number
- NCT04269525
- Lead Sponsor
- ZhiYong Peng
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description pneumonia UC-MSCs 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.
- Primary Outcome Measures
Name Time Method Oxygenation index on the day 14 after enrollment partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)
- Secondary Outcome Measures
Name Time Method IL-4 on the day 7,14,28 after enrollment IL-4 in pg/mL
28 day mortality on the day 28 after enrollment whether the patient survives
Hospital stay up to 6 months days of the patients in hospital
interleukin(IL)-2 on the day 7,14,28 after enrollment IL-2 in picogram(pg)/millilitre(mL)
2019-nCoV antibody test on the day 7,14,28 after enrollment whether or not the 2019-nCoV antibody is positive
2019-nCoV nucleic acid test on the day 7,14,28 after enrollment whether or not the 2019-nCoV nucleic acid test is positive
Improvement of lung imaging examinations on the day 7,14,28 after enrollment whether lung imaging examinations show the improvement of the pneumonia
White blood cell count on the day 7,14,28 after enrollment counts of white blood cell in a litre of blood
Procalcitonin on the day 7,14,28 after enrollment procalcitonin in microgram(ug)/L
Lymphocyte count on the day 7,14,28 after enrollment counts of lymphocyte in a litre (L) of blood
IL-6 on the day 7,14,28 after enrollment IL-6 in pg/mL
IL-10 on the day 7,14,28 after enrollment IL-10 in pg/mL
C-reactive protein(CRP) on the day 7,14,28 after enrollment CRP in microgram（μg）/L
CD4+ T-Lymphocytopenia on the day 7,14,28 after enrollment counts of CD4+ T-Lymphocytopenia in litre
tumor necrosis factor(TNF)-α on the day 7,14,28 after enrollment TNF-α in nanogram(ng)/L
γ-interferon(IFN) on the day 7,14,28 after enrollment γ-IFN in a thousand unit (KU)/L
natural killer cell(NK) on the day 7,14,28 after enrollment counts of NK in a litre
CD8+ T-Lymphocytopenia on the day 7,14,28 after enrollment counts of CD8+ T-Lymphocytopenia in a litre
Trial Locations
- Locations (1)
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China