Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells

Study Overview
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Brief Summary
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Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells

Detailed Description
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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.

Official Title
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Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Dental pulp mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Dental pulp mesenchymal stem cells were injected intravenously
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulp mesenchymal stem cells<br>1. 3, 7 days to increase the injection of mesenchymal stem cells | Biological: Dental pulp mesenchymal stem cells<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 3, 7 and 14 days |