Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 320
- 试验地点
- 6
- 主要终点
- survival time
研究概览
简要总结
Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. In this current prospective cohort, the investigators plan to organize four hospitals to determine the safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the treatment of patients with liver cirrhosis in next three years.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •aged 30-60 years
- •clinical diagnosis of compensated or decompensated liver
- •child-Pugh B/C (7-12 points)
- •expecting lifetime is over three years
排除标准
- •pregnant woman
- •patient with severe vascular diseases
- •patient with any organ failure
- •patient with any tumors
- •patient with HIV
- •patient who has been transplanted
- •patient treated with immunosuppressors
- •patient for whom the follow-up is considered impossible
- •patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
研究组 & 干预措施
mesenchymal stem cells
combination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)
干预措施: mesenchymal stem cells (Biological)
Conventional therapy
only apply for conventional medical therapy without any cell therapy
干预措施: Conventional therapy (Biological)
结局指标
主要结局
survival time
时间窗: 3-year follow up
次要结局
- Serum markers regarding lipid and sugar profile(0, 3, 6, 9 and 12 months)
- Serum markers regarding cytokine profile(0, 3, 6, 9 and 12 months)
- Serum markers regarding liver and kidney function(0, 3, 6, 9 and 12 months)
- Serum levels of Hepatitis B and C(0, 3, 6, 9 and 12 months)
- tolerance and the adverse events(3-year follow up)
- Changes of any clinical symptoms(3-year follow up)