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Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients

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: NCT04336254
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborators:
Beijing SH Bio-Tech Corporation, Beijing (CN)
Utooth Biological Technology Co., Ltd. Hubei (CN)
Information provided by (Responsible Party):
Ye Qingsong, Renmin Hospital of Wuhan University

Brief Summary:
This clinical trial is set out to evaluate the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by COVID-19; to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of COVID-19 in terms of reducing mortality and improving clinical prognosis; and to discover a new therapeutic strategy for COVID-19 using allogeneic human dental pulp mesenchymal stem cells.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) Other: Intravenous saline injection (Placebo) Phase 1 Phase 2

Detailed Description:

This clinical trial is set out to evaluate the followings:

  1. the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by COVID-19;
  2. to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of COVID-19 in terms of reducing mortality and improving clinical prognosis; and
  3. to discover a new therapeutic strategy for COVID-19 using allogeneic human dental pulp mesenchymal stem cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe Pneumonia of COVID-19:a Single-center, Prospective, Randomised Clinical Trial
Estimated Study Start Date : April 6, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: hDPSCs group
Routine treatment + Intravenous injection of human dental pulp stem cells
Biological: allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)
Intravenous injection of 3.0x10e7 human dental pulp stem cells solution (30ml) on day 1, day 4 and day 7, based on routine treatment of COVID-19

Placebo Comparator: Control group
Routine treatment + Intravenous saline injection (Placebo)
Other: Intravenous saline injection (Placebo)
Intravenous injection of 3ml of 0.9% saline on day 1, day 4 and day 7, based on routine treatment of COVID-19




Primary Outcome Measures :
  1. TTCI [ Time Frame: 1-28 days ]
    Time to Clinical Improvement


Secondary Outcome Measures :
  1. Lung lesion [ Time Frame: 1-28 days ]
    Lung Lesion by CT

  2. Immune function [ Time Frame: 1-28 days ]
    1. Th1 cytokines: IL-1β, IL- 2, TNF-a, ITN-γ;
    2. Th2 cytokines: IL- 4, IL- 6, IL- 10;
    3. Immunoglobulins: IgA, IgG, IgM, and total IgE;
    4. Lymphocyte counts: CD3+, CD4+, CD8+, CD16+,CD19+, CD56+.

  3. Time of SARS-CoV-2 clearance [ Time Frame: 1-28 days ]
    Time of SARS-CoV-2 test turns negative

  4. Blood test [ Time Frame: 1-28 days ]
    Blood cell count and classification

  5. SPO2 [ Time Frame: 1-28 days ]
    Pulse oximetry

  6. RR [ Time Frame: 1-28 days ]
    Respiratory rate

  7. Body temperature [ Time Frame: 1-28 days ]
    Body temperature

  8. Side effects in the treatment group [ Time Frame: 1-28 days ]
    Number of the included patients with hDPSCs-related adverse events, e.g. liver or kidney function failure

  9. C-reactive protein (mg/L) [ Time Frame: 1-28 days ]
    C-reactive protein in microgram per litre



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-65 years;
  2. Voluntarily participate in this clinical trial and sign off "informed consent form";
  3. Diagnosed with severe pneumonia of COVID: respiratory distress, RR >30 times / min; resting oxygen saturation of 93% or less; arterial partial pressure of oxygen / oxygen concentration 300mmHg; SARS-CoV-2 nucleic acid test was positive.
  4. Chest imaging confirm COVID-19 featured lesions in lung.

Exclusion Criteria:

  1. Receive any clinical trial drug treatment for COVID-2019 within 30 days before the screening assessment;
  2. Severe liver disease (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);
  3. Patients with known severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;
  4. Co-infection of HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;
  5. Female patients who have no sexual protection in the last 30 days prior to the screening assessment;
  6. Pregnant or lactating women or women using estrogen contraception;
  7. Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;
  8. Other conditions that the researchers consider not suitable for participating in this clinical trial.

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): NCT04336254


Contacts
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Contact: Qingsong Ye, PhD,DDS +8615858242516 qingsongye@foxmail.com
Contact: Chenliang Zhou, PhD +862788041919 ext 83920

Locations
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China, Hubei
Renmin Hospital of Wuhan University (East Campus) Recruiting
Wuhan, Hubei, China
Contact: Chenliang Zhou, PhD    +86 027 88041919 ext 83920      
Sponsors and Collaborators
Renmin Hospital of Wuhan University
Beijing SH Bio-Tech Corporation, Beijing (CN)
Utooth Biological Technology Co., Ltd. Hubei (CN)
Investigators
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Study Chair: Prof. Qingsong Ye, PhD,DDS Center for Regenerative Medicine, Renmin Hospital of Wuhan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ye Qingsong, Professor, Director, Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT04336254    
Other Study ID Numbers: 2020K-G005
hDPSC-CoVID-2019-02-2020 ( Other Identifier: Renmin Hospital of Wuhan University )
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 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
Keywords provided by Ye Qingsong, Renmin Hospital of Wuhan University:
Cronovirus
Human Dental Pulp Stem Cells
Dental Stem Cell Banking