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

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

Study Overview

• Status: Unknown
• Conditions: Liver Failure, Acute
• Intervention / Treatment: Procedure: Standard care for ALF; Procedure: hiHep Bioartificial Liver Support System

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 Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Standard care for ALF	Procedure: Standard care for ALF; A standard of care for subjects with acute liver failure.
Experimental: Experimental group; Continuous treatment with the hiHep bioartificial liver support system.	Procedure: hiHep Bioartificial Liver Support System; Continuous treatment with the hiHep bioartificial liver support system for a minimum of 3 days to a maximum of 14 days. The subject's ultrafiltrated blood is circulated through 4 cartridges. The parameter is set to Circuit 1：120-200ml/min；Circuit 2：30-50ml/min；Circuit 3：200 ml/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival of ALF subjects	Overall survival in subjects with acute liver failure will be summarized and compared with control subjects through Study Day 28.	Study Day 1 through Study Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Proportion of subjects who suffer complications caused by bioartificial liver support system	Study Day 1 through Study Day 60

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Collaborators: Chinese Academy of Sciences
• Investigators: Principal Investigator: Shaolin Ma, MD., Department of ICU, Shanghai East Hospital, School of Medicine, Tongji University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Acute Liver Failure; Bioartificial Liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
• Other Study ID Numbers: DFSC-2015（CR）-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No