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

• ClinicalTrials.gov Identifier: NCT04302519
• Recruitment Status: Unknown
• First Posted: March 10, 2020
• Last Update Posted: March 10, 2020
• Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Information provided by (Responsible Party): CAR-T (Shanghai) Biotechnology Co., Ltd.

Tracking Information

• First Submitted Date: February 27, 2020
• First Posted Date: March 10, 2020
• Last Update Posted Date: March 10, 2020
• Estimated Study Start Date: March 5, 2020
• Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 9, 2020)

Disppear time of ground-glass shadow in the lungs [ Time Frame: 14 days ]

Kaplan-meier method was used to calculate the median glassy shadow time in all subjects

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 9, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
• 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.

• Study Type: Interventional
• Study Phase: Early Phase 1

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Dental pulp mesenchymal stem cells were injected intravenously

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: COVID-19

Intervention

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.

Study Arms

Experimental: Pulp mesenchymal stem cells

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

Intervention: Biological: Dental pulp mesenchymal stem cells

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 9, 2020): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2021
• Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04302519
• Other Study ID Numbers: KT005HB001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Verification Date: February 2020