Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 covid19
Started Mar 2020
Typical duration for early_phase_1 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2020
CompletedStudy Start
First participant enrolled
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedMarch 10, 2020
February 1, 2020
1.3 years
February 27, 2020
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Disppear time of ground-glass shadow in the lungs
Kaplan-meier method was used to calculate the median glassy shadow time in all subjects
14 days
Secondary Outcomes (2)
Absorption of Lung shadow absorption by CT Scan-Chest
7, 14, 28 and 360 days
Changes of blood oxygen
3, 7 and 14 days
Study Arms (1)
Pulp mesenchymal stem cells
EXPERIMENTAL1\. 3, 7 days to increase the injection of mesenchymal stem cells
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liwei cheng, doctor
Research office of wuhan renmin university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 10, 2020
Study Start
March 5, 2020
Primary Completion
June 30, 2021
Study Completion
July 30, 2021
Last Updated
March 10, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share