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

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ClinicalTrials.gov Identifier: NCT04302519
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
CAR-T (Shanghai) Biotechnology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 27, 2020
First Posted Date  ICMJE March 10, 2020
Last Update Posted Date March 10, 2020
Estimated Study Start Date  ICMJE March 5, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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  ICMJE COVID-19
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaoyang Zhou, doctor 18986033792 xiaoyangzh@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04302519
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party CAR-T (Shanghai) Biotechnology Co., Ltd.
Study Sponsor  ICMJE CAR-T (Shanghai) Biotechnology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Liwei cheng, doctor Research office of wuhan renmin university
PRS Account CAR-T (Shanghai) Biotechnology Co., Ltd.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP