NCT04302519Unknown早期 1 期
Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
CAR-T (Shanghai) Biotechnology Co., Ltd.0 个研究点目标入组 24 人开始时间: 2020年3月5日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 24
- 主要终点
- Disppear time of ground-glass shadow in the lungs
研究概览
简要总结
Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells
详细描述
Open, single center, single arm test design. Plan to enroll 24 subjects. On the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial.
Injection dose: 1.0x106 cells /kg. Injection method: slowly and quietly drop 50 mL of normal saline, then the endodontic mesenchymal stem cell injection (after 60 min), and then 50 mL of normal saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18, age ≤ 75, gender unlimited;
- •novel coronavirus diagnosed severe pneumonia and confirmed no effective treatment plan. (severe patients meet any of the following: (1) respiratory distress, RR > 30 times / minute; (2) resting state, oxygen saturation is less than 93%; (3) arterial oxygen partial pressure (PaO2) / oxygen inhalation (FiO2) is less than 300 mmHg (1mm Hg=0.133 kPa).
- •Those who voluntarily participate in the clinical study and can cooperate with researchers to carry out the study, and the patients themselves or their legal representatives voluntarily sign the informed consent.
排除标准
- •Patients with autoimmune diseases in the past or screening;
- •Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
- •Known or self-reported HIV or syphilis infected persons;
- •Have participated in stem cell clinical research;
- •Pregnant or lactating women or those who have fertility plans in the past year;
- •The estimated life cycle is less than 48 hours;
- •Those who participated in other clinical trials within 3 months before screening;
- •Other conditions that the researcher thinks are not suitable for participating in the experiment.
结局指标
主要结局
Disppear time of ground-glass shadow in the lungs
时间窗: 14 days
Kaplan-meier method was used to calculate the median glassy shadow time in all subjects
次要结局
- Changes of blood oxygen(3, 7 and 14 days)
- Absorption of Lung shadow absorption by CT Scan-Chest(7, 14, 28 and 360 days)
研究者
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