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

Liver Failure, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03084198
• Other study ID #: DFSC-2015(CR)-05
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2017
• Last updated: April 24, 2017
• Start date: June 2017
• Est. completion date: June 2020

Study information

• Verified date: April 2017
• Source: Shanghai East Hospital
• Contact: Shaolin Ma, MD.
• Phone: +8613310167499
• Email: m_slin[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Liver Failure
• Liver Failure, Acute

Intervention

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.
• Standard care for ALF
A standard of care for subjects with acute liver failure.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai East Hospital	Chinese Academy of Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complication rate	Proportion of subjects who suffer complications caused by bioartificial liver support system	Study Day 1 through Study Day 60