Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
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|ClinicalTrials.gov Identifier: NCT04302519|
Recruitment Status : Unknown
Verified February 2020 by CAR-T (Shanghai) Biotechnology Co., Ltd..
Recruitment status was: Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: Dental pulp mesenchymal stem cells||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Dental pulp mesenchymal stem cells were injected intravenously|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells|
|Estimated Study Start Date :||March 5, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||July 30, 2021|
Experimental: Pulp mesenchymal stem cells
1. 3, 7 days to increase the injection of mesenchymal stem cells
Biological: Dental 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.
- Disppear time of ground-glass shadow in the lungs [ Time Frame: 14 days ]Kaplan-meier method was used to calculate the median glassy shadow time in all subjects
- Absorption of Lung shadow absorption by CT Scan-Chest [ Time Frame: 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 [ Time Frame: 3, 7 and 14 days ]T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302519
|Contact: Xiaoyang Zhou, email@example.com|
|Study Director:||Liwei cheng, doctor||Research office of wuhan renmin university|
|Responsible Party:||CAR-T (Shanghai) Biotechnology Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||March 10, 2020 Key Record Dates|
|Last Update Posted:||March 10, 2020|
|Last Verified:||February 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
Respiratory Tract Diseases