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

Unknown status
COVID-19

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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Contacts

Xiaoyang Zhou, doctor
18986033792
xiaoyangzh@hotmail.com

Liwei cheng, doctor, Study Director
Research office of wuhan renmin university

CAR-T (Shanghai) Biotechnology Co., Ltd.
NCT Number
MeSH Terms
Pneumonia