Back to resultsNovel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Primary Purpose
COVID-19
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Dental pulp mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulp mesenchymal stem cells
Arm Description
1. 3, 7 days to increase the injection of mesenchymal stem cells
Outcomes
Primary Outcome Measures
Disppear time of ground-glass shadow in the lungs
Kaplan-meier method was used to calculate the median glassy shadow time in all subjects
Secondary Outcome Measures
Absorption of Lung shadow absorption by CT Scan-Chest
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
T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14
Full Information
NCT ID
NCT04302519
First Posted
February 27, 2020
Last Updated
March 9, 2020
Sponsor
CAR-T (Shanghai) Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04302519
Brief Title
Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Official Title
Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CAR-T (Shanghai) Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Dental pulp mesenchymal stem cells were injected intravenously
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulp mesenchymal stem cells
Arm Type
Experimental
Arm Description
1. 3, 7 days to increase the injection of mesenchymal stem cells
Intervention Type
Biological
Intervention Name(s)
Dental pulp mesenchymal stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disppear time of ground-glass shadow in the lungs
Description
Kaplan-meier method was used to calculate the median glassy shadow time in all subjects
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Absorption of Lung shadow absorption by CT Scan-Chest
Description
Kaplan-meier method was used to calculate the median lung shadow absorption of all subjects on 7, 14, 28, and 360 days
Time Frame
7, 14, 28 and 360 days
Title
Changes of blood oxygen
Description
T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14
Time Frame
3, 7 and 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyang Zhou, doctor
Phone
18986033792
Email
xiaoyangzh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liwei cheng, doctor
Organizational Affiliation
Research office of wuhan renmin university
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
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