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
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- TTCI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
hDPSCs group
Routine treatment + Intravenous injection of human dental pulp stem cells
干预措施: allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) (Biological)
Control group
Routine treatment + Intravenous saline injection (Placebo)
干预措施: Intravenous saline injection (Placebo) (Other)
结局指标
主要结局
TTCI
时间窗: 1-28 days
Time to Clinical Improvement
次要结局
- SPO2(1-28 days)
- Lung lesion(1-28 days)
- Body temperature(1-28 days)
- Blood test(1-28 days)
- Side effects in the treatment group(1-28 days)
- Immune function(1-28 days)
- C-reactive protein (mg/L)(1-28 days)
- Time of SARS-CoV-2 clearance(1-28 days)
- RR(1-28 days)
研究者
Ye Qingsong
Professor, Director
Renmin Hospital of Wuhan University