Safety and Efficacy of Human Autologous Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- one year survival rate
研究概览
简要总结
HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis.
Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems.
stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.
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
- None
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
- •HBV-related liver cirrhosis
- •Child-Pugh score 9-15
- •Written consent
排除标准
- •Hepatocellular carcinoma or other malignancies
- •Severe problems in other vital organs(e.g.theheart,renal or lungs)
- •Pregnant or lactating women
- •Severe bacteria infection
- •Anticipated with difficulty of follow-up observation
- •Other candidates who are judged to be not applicable to this study by doctors
结局指标
主要结局
one year survival rate
时间窗: one year after treatment
次要结局
- AFP(1week, 4weeks, 3months, 6months, 9 months and 1year after treatment)
- MELD score(1week, 4weeks, 3months, 6months, 9 months and 1year after treatment)
- renal function(1week, 4weeks, 3months, 6months, 9 months and 1year after treatment)
- child score(1week, 4weeks, 3months, 6months, 9 months and 1year after treatment)
研究者
Han Ying
professor
Air Force Military Medical University, China