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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04302519
• Other study ID #: KT005HB001
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 5, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2020
• Source: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Contact: Xiaoyang Zhou, doctor
• Phone: 18986033792
• Email: xiaoyangzh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CAR-T (Shanghai) Biotechnology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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