COVID-19
Conditions
Keywords
Cronovirus, Human Dental Pulp Stem Cells, Dental Stem Cell Banking
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: 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.
Interventions
BIOLOGICALallogeneic 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
OTHERIntravenous 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
Sponsors
Beijing SH Bio-Tech Corporation, Beijing (CN)
Utooth Biological Technology Co., Ltd. Hubei (CN)
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TTCI | 1-28 days | Time to Clinical Improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune function | 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+. |
| Time of SARS-CoV-2 clearance | 1-28 days | Time of SARS-CoV-2 test turns negative |
| Blood test | 1-28 days | Blood cell count and classification |
| SPO2 | 1-28 days | Pulse oximetry |
| Lung lesion | 1-28 days | Lung Lesion by CT |
| Body temperature | 1-28 days | Body temperature |
| Side effects in the treatment group | 1-28 days | Number of the included patients with hDPSCs-related adverse events, e.g. liver or kidney function failure |
| C-reactive protein (mg/L) | 1-28 days | C-reactive protein in microgram per litre |
| RR | 1-28 days | Respiratory rate |
Countries
China
Contacts
Primary ContactQingsong Ye, PhD,DDS
Backup ContactChenliang Zhou, PhD
Outcome results
None listed