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临床试验/NCT01728688
NCT01728688Unknown1 期

Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2012年9月1日最近更新:
适应症

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

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

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Han Ying

professor

Air Force Military Medical University, China

研究点 (1)

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