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

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

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

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Biological: 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
• Enrollment (Anticipated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyang Zhou, doctor; Phone Number: 18986033792; Email: xiaoyangzh@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pulp mesenchymal stem cells; 1. 3, 7 days to increase the injection of mesenchymal stem cells	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Investigators: Study Director: Liwei cheng, doctor, Research office of wuhan renmin university

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 5, 2020
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): July 30, 2021

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (ACTUAL): March 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: KT005HB001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No