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

Tongji University

Status: Unknown

Conditions: Liver Failure, Acute

Treatments: Procedure: Standard care for ALF; Procedure: hiHep Bioartificial Liver Support System

Study type: Interventional

Funder types: Other

Identifiers

NCT03084198

DFSC-2015（CR）-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Control group

Active Comparator group

Description:

Standard care for ALF

Treatment:

Procedure: Standard care for ALF

Experimental group

Experimental group

Description:

Continuous treatment with the hiHep bioartificial liver support system.

Treatment:

Procedure: hiHep Bioartificial Liver Support System