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

Early Phase 1

• Conditions: COVID-19
• Interventions: Biological: Dental pulp mesenchymal stem cells

• Registration Number: NCT04302519
• Lead Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-27
• Study Start: 2020-03-05
• Study First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulp mesenchymal stem cells	Dental pulp mesenchymal stem cells	1. 3, 7 days to increase the injection of mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Disppear time of ground-glass shadow in the lungs	14 days	Kaplan-meier method was used to calculate the median glassy shadow time in all subjects

Secondary Outcome Measures

Name	Time	Method
Changes of blood oxygen	3, 7 and 14 days	T test was used to compare the blood oxygen values of each subject at day 3, 7 and 14
Absorption of Lung shadow absorption by CT Scan-Chest	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