Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Validity evaluation by detection of the Model for end-stage Liver Disease score of participants
研究概览
简要总结
- Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.
- Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat.
- Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.
详细描述
This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis B cirrhosis to evaluate its safety and efficacy,
This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value;
- •The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points.
- •Have not received stem cell therapy in the recent 6 months;
- •Subjects will be able to sign the informed consent in accordance with the study procedures and instructions.
排除标准
- •Insufficiency of vital organs, such as heart, kidney and lung;
- •End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc.
- •Concomitant peritonitis, pneumonia, or other types of infection not under control;
- •Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine;
- •Positive serum HIV antibody and syphilis antibody;
- •Alpha fetoprotein>400ng/mL with primary liver cancer or without imaging evidence;
- •Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ;
- •Patients with severe mental illness and cognitive impairment;
研究组 & 干预措施
Treatment Group
Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6*10^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 * 10 ^ 7 (30 ml)
干预措施: Peripheral iv (Biological)
结局指标
主要结局
Validity evaluation by detection of the Model for end-stage Liver Disease score of participants
时间窗: 12 month
After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. 40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality \<9 - 1.9% observed mortality
次要结局
- Validity evaluation by detection of the child-pugh of participants(12 month)
- Safety evaluation by detecting Blood routine(12 month)