Safety and Efficacy of Human Autologous Peripheral Blood 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.
In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and autologous PBSC transplantation can significantly improve liver synthetic function. But further studied was needed to confirm the safety and efficacy of PBSC transplantation. In this study, a prospective, randomized, parallel clinical study was designed. The patients with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate the safety and efficacy of human autologous PBSCs 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.the heart,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
- MELD score(1week, 4weeks,3months, 6months, 9months and 1year after treatment)
- Child Pugh Score(1week, 4weeks,3months, 6months, 9months and 1year after treatment)
- alpha fetoprotein(1week, 4weeks,3months, 6months, 9months and 1year after treatment)
- renal function(1week, 4weeks,3months, 6months, 9months and 1year after treatment)
研究者
Han Ying
professor
Air Force Military Medical University, China