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.
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.
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
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.
Renmin Hospital of Wuhan University (East Campus)
Wuhan, Hubei, China
Investigator: Chenliang Zhou, PhD
Contact: +86 027 88041919
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