IS and Viral Hepatitis

Monday July 02, 2018 from 16:30 to 17:30

Room: Hall 10 - Exhibition

C399.6 Phase 1/2a trial of a bioartificial liver support system (LifeLiver) for acute liver failure patients

Seung Wook Han, Korea

Resident
General Surgery
Samsung Medical Center

Abstract

Phase 1/2a Trial of a Bioartificial Liver Support System (LifeLiver) for Acute Liver Failure Patients

Sanghoon Lee1, Ji-Hyun Lee2,3, Doo-Hoon Lee4, Hey-Jung Park2, Young-A Kim2, Mi Na Park2, Jeong-Kwon Noh4, Jong Gab Jung4, Jong Eun Lee4, Mal Sook Yang4, Eun Mi Jang4, Hee-Hoon Yoon4, Sojeong Yoon1, Seung Wook Han1, Suk-Koo Lee1.

1Department of Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea; 2Stem Cell and Regenerative Medicine Institute, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea; 3Department of Health Sciences and Technology, SAIHST, Sungkyunkwan University, Seoul, Korea; 4Biomedical Research Center, Lifeliver, Co. Ltd., Yongin, Korea

Bioartificial liver (BAL) support offers a potential means of improving survival of acute liver failure (ALF) patients by providing partial liver function until a suitable donor liver is found or the native liver undergoes regeneration. Previous studies have suggested that ALF patients treated using BAL maintain a more stable medical condition, which may positively influence outcome after liver transplant (LT). This clinical trial was conducted to evaluate the safety and efficacy of the LifeLiver BAL system in ALF patients.
Patients with evidence of acute liver failure exhibiting hepatic encephalopathy grade 2 or worse who were listed for deceased donor liver transplant were eligible for enrollment. Hepatocytes were harvested from 3~4 weeks old male pigs weighing 4 to 10 kg, raised in a sterile environment. The isolate hepatocytes were cultured to form spheroids and were then mixed with 1.5% alginate solution and placed in a high content/speed immobilization apparatus and dropped into 100mM calcium solution. The Ca-alginate-immobilized hepatocyte spheroid beads were packed within the bioreactor of the BAL system. BAL treatment was continued for up to 12 hours.
Six patients were given BAL treatment and were included in the safety analysis. Adverse events related to BAL treatment included coagulopathy (increased INR), pneumonia, sepsis and disease progression. One patient developed upper gastrointestinal tract bleeding and sepsis following BAL treatment and eventually died while waiting for transplant. No evidence of porcine endogenous retrovirus (PERV) were seen. 
Five patients completed the study per protocol and were included in the efficacy analysis. Four patients showed apparent decrease in serum ammonia levels and MELD scores during BAL treatment. Hepatic encephalopathy either decreased or remained stable throughout the BAL treatment period in 4 patients. 
The LifeLiver BAL support system showed safety and efficacy in ALF patients with hepatic encephalopathy. Two patients were successfully bridged to liver transplantation.

Presentations by Seung Wook Han



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