Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
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|ClinicalTrials.gov Identifier: NCT04302519|
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
|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
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, firstname.lastname@example.org|
|Study Director:||Liwei cheng, doctor||Research office of wuhan renmin university|