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

Not Applicable

• Conditions: Liver Failure, Acute
• Interventions: Procedure: Standard care for ALF; Procedure: hiHep Bioartificial Liver Support System

• Registration Number: NCT03084198
• Lead Sponsor: Shanghai East Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-20
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25
• Study Start: 2017-06
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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;

Exclusion Criteria

• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard care for ALF	Standard care for ALF
Experimental group	hiHep Bioartificial Liver Support System	Continuous treatment with the hiHep bioartificial liver support system.

Primary Outcome Measures

Name	Time	Method
Overall survival of ALF subjects	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.

Secondary Outcome Measures

Name	Time	Method
Complication rate	Study Day 1 through Study Day 60	Proportion of subjects who suffer complications caused by bioartificial liver support system