Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 主要终点
- Overall survival of ALF subjects
研究概览
简要总结
This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
详细描述
Liver damage remains a life-threatening syndrome. With the increasing number of patients awaiting transplantation, efforts have been made to develop extracorporeal methods to support or replace the function of the failing organ. A bioartificial liver support system has to provide the main functions of the liver: detoxification, synthesis, and regulation. It may prolonger the expected survival time of acute liver failure patients. Direct reprogramming of fibroblasts to hepatic lineages could offer a new type of solution to bioartificial liver support system. The investigators have already generated human induced hepatocytes (hiHeps) from fibroblasts by lentiviral expression of FOXA3, HNF1A, and HNF4A. hiHeps express hepatic gene programs, can be expanded in vitro, and display functions characteristic of mature hepatocytes, including cytochrome P450 enzyme activity and biliary drug clearance. hiHeps can restore the liver function and prolong survival. This study tends to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight more than 45 kg;
- •Age more than 18;
- •Diagnosis of ALF;
- •Subjects must not be listed for transplant at the time of Enrollment or, if listed, in the opinion of the Investigator are unlikely to be transplanted within 72 hours;
排除标准
- •Acute clinical symptoms that are likely to result in death within 48 hours;
- •Presence of sepsis or septic shock;
- •Concomitant disease including chronic congestive heart failure, severe vascular disease, emphysema, AIDS, cancer;
- •Portal hypertension;
- •Liver dysfunction due to trauma;
结局指标
主要结局
Overall survival of ALF subjects
时间窗: Study Day 1 through Study Day 28
Overall survival in subjects with acute liver failure will be summarized and compared with control subjects through Study Day 28.
次要结局
- Complication rate(Study Day 1 through Study Day 60)