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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2020-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Liver Failure, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Standard care for ALF

Group Type ACTIVE_COMPARATOR

Standard care for ALF

Intervention Type PROCEDURE

A standard of care for subjects with acute liver failure.

Experimental group

Continuous treatment with the hiHep bioartificial liver support system.

Group Type EXPERIMENTAL

hiHep Bioartificial Liver Support System

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Standard care for ALF

A standard of care for subjects with acute liver failure.

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No