Clinical Trial: Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure

Brief Summary: This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.

Detailed Summary: 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.
Sponsor: Shanghai East Hospital

Current Primary Outcome: Overall survival of ALF subjects [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Complication rate [ Time Frame: Study Day 1 through Study Day 60 ]

Proportion of subjects who suffer complications caused by bioartificial liver support system


Original Secondary Outcome: Same as current

Information By: Shanghai East Hospital

Dates:
Date Received: March 14, 2017
Date Started: June 2017
Date Completion: June 2020
Last Updated: April 24, 2017
Last Verified: April 2017