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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Dental pulp mesenchymal stem cells Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Official Title: Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Estimated Study Start Date : March 5, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302519


Contacts
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Contact: Xiaoyang Zhou, doctor 18986033792 xiaoyangzh@hotmail.com

Sponsors and Collaborators
CAR-T (Shanghai) Biotechnology Co., Ltd.
Investigators
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Study Director: Liwei cheng, doctor Research office of wuhan renmin university
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Responsible Party: CAR-T (Shanghai) Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04302519    
Other Study ID Numbers: KT005HB001
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections