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

NCT ID: NCT04302519

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-05
• Study Completion Date: 2021-07-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulp mesenchymal stem cells

1\. 3, 7 days to increase the injection of mesenchymal stem cells

Group Type: EXPERIMENTAL

Dental pulp mesenchymal stem cells

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CAR-T (Shanghai) Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liwei cheng, doctor

Role: STUDY_DIRECTOR

Research office of wuhan renmin university

Central Contacts

Xiaoyang Zhou, doctor

Role: CONTACT

xiaoyangzh@hotmail.com

18986033792

Other Identifiers

KT005HB001

Identifier Type: -

Identifier Source: org_study_id