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
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.

Unknown status
COVID-19

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

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

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
China
Locations

Renmin Hospital of Wuhan University (East Campus)
Wuhan, Hubei, China

Investigator: Chenliang Zhou, PhD
Contact: +86 027 88041919

Contacts

Qingsong Ye, PhD,DDS
+8615858242516
qingsongye@foxmail.com

Chenliang Zhou, PhD
+862788041919 - 83920

Prof. Qingsong Ye, PhD,DDS, Study Chair
Center for Regenerative Medicine, Renmin Hospital of Wuhan University

Renmin Hospital of Wuhan University
NCT Number
Keywords
Cronovirus
Human Dental Pulp Stem Cells
Dental Stem Cell Banking
MeSH Terms
COVID-19