COVID-19
Conditions
Brief summary
Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells
Detailed description
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.
Interventions
BIOLOGICALDental pulp mesenchymal stem cells
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.
Sponsors
CAR-T (Shanghai) Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dental pulp mesenchymal stem cells were injected intravenously
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Age ≥ 18, age ≤ 75, gender unlimited; * 2\. 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). * 3\. 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.
Exclusion criteria
* 1\. Patients with autoimmune diseases in the past or screening; * 2\. 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; * 3\. Known or self-reported HIV or syphilis infected persons; * 4\. Have participated in stem cell clinical research; * 5\. Pregnant or lactating women or those who have fertility plans in the past year; * 6\. The estimated life cycle is less than 48 hours; * 7\. Those who participated in other clinical trials within 3 months before screening; * 8\. Other conditions that the researcher thinks are not suitable for participating in the experiment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disppear time of ground-glass shadow in the lungs | 14 days | Kaplan-meier method was used to calculate the median glassy shadow time in all subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absorption of Lung shadow absorption by CT Scan-Chest | 7, 14, 28 and 360 days | Kaplan-meier method was used to calculate the median lung shadow absorption of all subjects on 7, 14, 28, and 360 days |
| Changes of blood oxygen | 3, 7 and 14 days | T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14 |
Contacts
Primary ContactXiaoyang Zhou, doctor
Outcome results
None listed