Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Oxygenation index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Oxygenation index
时间窗: on the day 14 after enrollment
partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)
次要结局
- IL-4(on the day 7,14,28 after enrollment)
- interleukin(IL)-2(on the day 7,14,28 after enrollment)
- 28 day mortality(on the day 28 after enrollment)
- Hospital stay(up to 6 months)
- Procalcitonin(on the day 7,14,28 after enrollment)
- 2019-nCoV antibody test(on the day 7,14,28 after enrollment)
- 2019-nCoV nucleic acid test(on the day 7,14,28 after enrollment)
- Improvement of lung imaging examinations(on the day 7,14,28 after enrollment)
- White blood cell count(on the day 7,14,28 after enrollment)
- Lymphocyte count(on the day 7,14,28 after enrollment)
- IL-6(on the day 7,14,28 after enrollment)
- IL-10(on the day 7,14,28 after enrollment)
- C-reactive protein(CRP)(on the day 7,14,28 after enrollment)
- CD4+ T-Lymphocytopenia(on the day 7,14,28 after enrollment)
- tumor necrosis factor(TNF)-α(on the day 7,14,28 after enrollment)
- γ-interferon(IFN)(on the day 7,14,28 after enrollment)
- natural killer cell(NK)(on the day 7,14,28 after enrollment)
- CD8+ T-Lymphocytopenia(on the day 7,14,28 after enrollment)
研究者
ZhiYong Peng
professor
Zhongnan Hospital