HepaHope Product Publications

International Liver Congress

June 12-15, 2008
Hong Kong, China

Assessment of HepaHope bio-artificial liver (BAL) system designed for treating liver failure patients

Sung-Soo Park1, Jaeho Jung1, Delai Zhao1, Sunny Yang1, Sunnie Kim1, Sam Lee1, Hyoung Yoon1, Young Park1, Nercy Fernandez1, Robert G. Gish2, Brendan M. McGuire3, Angela Panoskaltsis-Mortari4, Han Chu Lee5, Dong-Jin Suh5

1HepaHope Inc, 2California Pacific Medical Center, 3University of Alabama, 4University of Minnesota,
5Mayo Clinic, 6University of Ulsan

A large number of patients die annually from liver failure worldwide. HepaPheresis System is an extracorporeal BAL system to treat such liver failure patients as a potential life-saving alternative. The BAL contains porcine liver slices with multiple, native cell types in well-preserved structures that allow efficient biochemical function and removal of toxins from patients’ blood. Safety of source material has been examined. Source pig livers were free of potential zoonotic infectious agents such as swine hepatitis E virus, porcine reo, rota and adenoviruses. PERV RNA was present three out of eight pig livers, but co-culture assay for the detection of infectious PERV showed no PERV infection on 293 human embryonic kidney cells. Several in vitro and in vivo studies have been conducted to evaluate safety and efficacy of the system. The liver slices in the system were biologically functional by clearing ammonia (60-80%) and lidocaine (60-70%) and accumulating their metabolites (BUN and DMX). In pre-clinical safety study of large canine (>20kg) study, all animals (8 dogs) survived the treatment without major clinical complications. There were no adverse immune reactions (canine IgG/IgM and inflammatory cytokines, IL-10 and IFN-γ). PERV RNA was not detected in all animals. Pre-clinical efficacy data utilizing a canine acute liver failure model showed statistically significant (P<0.05) outcome in survival and other biomarkers (lactate, K, pH, phosphorous) with improvement in intracranial pressure. These favorable pre-clinical study results and no zoonotic infectious agents in source animals have encouraged feasibility studies in human patients with liver failure.