Back to resultsSafety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)
Intravenous saline injection (Placebo)
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Cronovirus, Human Dental Pulp Stem Cells, Dental Stem Cell Banking
Eligibility Criteria
Inclusion Criteria:
- Aged 18-65 years;
- Voluntarily participate in this clinical trial and sign off "informed consent form";
- 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.
- Chest imaging confirm COVID-19 featured lesions in lung.
Exclusion Criteria:
- Receive any clinical trial drug treatment for COVID-2019 within 30 days before the screening assessment;
- Severe liver disease (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);
- 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;
- Co-infection of HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;
- Female patients who have no sexual protection in the last 30 days prior to the screening assessment;
- Pregnant or lactating women or women using estrogen contraception;
- Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;
- Other conditions that the researchers consider not suitable for participating in this clinical trial.
Sites / Locations
- Renmin Hospital of Wuhan University (East Campus)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
hDPSCs group
Control group
Arm Description
Routine treatment + Intravenous injection of human dental pulp stem cells
Routine treatment + Intravenous saline injection (Placebo)
Outcomes
Primary Outcome Measures
TTCI
Time to Clinical Improvement
Secondary Outcome Measures
Lung lesion
Lung Lesion by CT
Immune function
Th1 cytokines: IL-1β, IL- 2, TNF-a, ITN-γ;
Th2 cytokines: IL- 4, IL- 6, IL- 10;
Immunoglobulins: IgA, IgG, IgM, and total IgE;
Lymphocyte counts: CD3+, CD4+, CD8+, CD16+,CD19+, CD56+.
Time of SARS-CoV-2 clearance
Time of SARS-CoV-2 test turns negative
Blood test
Blood cell count and classification
SPO2
Pulse oximetry
RR
Respiratory rate
Body temperature
Body temperature
Side effects in the treatment group
Number of the included patients with hDPSCs-related adverse events, e.g. liver or kidney function failure
C-reactive protein (mg/L)
C-reactive protein in microgram per litre
Full Information
NCT ID
NCT04336254
First Posted
March 28, 2020
Last Updated
March 8, 2021
Sponsor
Renmin Hospital of Wuhan University
Collaborators
Beijing SH Bio-Tech Corporation, Beijing (CN), Utooth Biological Technology Co., Ltd. Hubei (CN)
1. Study Identification
Unique Protocol Identification Number
NCT04336254
Brief Title
Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Renmin Hospital of Wuhan University
Collaborators
Beijing SH Bio-Tech Corporation, Beijing (CN), Utooth Biological Technology Co., Ltd. Hubei (CN)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This clinical trial is set out to evaluate the followings:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Cronovirus, Human Dental Pulp Stem Cells, Dental Stem Cell Banking
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hDPSCs group
Arm Type
Experimental
Arm Description
Routine treatment + Intravenous injection of human dental pulp stem cells
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Routine treatment + Intravenous saline injection (Placebo)
Intervention Type
Biological
Intervention Name(s)
allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Intravenous saline injection (Placebo)
Intervention Description
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 Measure Information:
Title
TTCI
Description
Time to Clinical Improvement
Time Frame
1-28 days
Secondary Outcome Measure Information:
Title
Lung lesion
Description
Lung Lesion by CT
Time Frame
1-28 days
Title
Immune function
Description
Th1 cytokines: IL-1β, IL- 2, TNF-a, ITN-γ;
Th2 cytokines: IL- 4, IL- 6, IL- 10;
Immunoglobulins: IgA, IgG, IgM, and total IgE;
Lymphocyte counts: CD3+, CD4+, CD8+, CD16+,CD19+, CD56+.
Time Frame
1-28 days
Title
Time of SARS-CoV-2 clearance
Description
Time of SARS-CoV-2 test turns negative
Time Frame
1-28 days
Title
Blood test
Description
Blood cell count and classification
Time Frame
1-28 days
Title
SPO2
Description
Pulse oximetry
Time Frame
1-28 days
Title
RR
Description
Respiratory rate
Time Frame
1-28 days
Title
Body temperature
Description
Body temperature
Time Frame
1-28 days
Title
Side effects in the treatment group
Description
Number of the included patients with hDPSCs-related adverse events, e.g. liver or kidney function failure
Time Frame
1-28 days
Title
C-reactive protein (mg/L)
Description
C-reactive protein in microgram per litre
Time Frame
1-28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-65 years;
Voluntarily participate in this clinical trial and sign off "informed consent form";
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.
Chest imaging confirm COVID-19 featured lesions in lung.
Exclusion Criteria:
Receive any clinical trial drug treatment for COVID-2019 within 30 days before the screening assessment;
Severe liver disease (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);
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;
Co-infection of HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;
Female patients who have no sexual protection in the last 30 days prior to the screening assessment;
Pregnant or lactating women or women using estrogen contraception;
Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;
Other conditions that the researchers consider not suitable for participating in this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingsong Ye, PhD,DDS
Phone
+8615858242516
Email
qingsongye@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chenliang Zhou, PhD
Phone
+862788041919
Ext
83920
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Qingsong Ye, PhD,DDS
Organizational Affiliation
Center for Regenerative Medicine, Renmin Hospital of Wuhan University
Official's Role
Study Chair
Facility Information:
Facility Name
Renmin Hospital of Wuhan University (East Campus)
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenliang Zhou, PhD
Phone
+86 027 88041919
Ext
83920
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32532356
Citation
Ye Q, Wang H, Xia X, Zhou C, Liu Z, Xia ZE, Zhang Z, Zhao Y, Yehenala J, Wang S, Zhou G, Hu K, Wu B, Wu CT, Wang S, He Y. Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II). Trials. 2020 Jun 12;21(1):520. doi: 10.1186/s13063-020-04380-5.
Results Reference
derived
Learn more about this trial
Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients
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