HepaHope Product Publications

World Transplant Congress (WTC)

July 22-27, 2006
BOSTON, USA

In Vivo CCharacterization on animals of a Novel Porcine Liver Slice-Filled Bio‑artificial Liver designed for Treatment of Liver Failure Patients

Holger P. Behrsing1, Jennifer Tam1, Brad Gray1, Andy Do1, Young Park1, Hyoung Yoon1, Delai Zhao1, Charles Gropper1, Jaeho Jung1, Robert G. Gish2, Brendan M. McGuire3, Angela Panoskaltsis-Mortari4, Young-Suk Lim5, Han Chu Lee5, Dong-Jin Suh5, Sung-Soo Park1

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

A large number of patients die annually from acute liver failure worldwide. Dialysis with a bio-artificial liver (BAL) may be a potential therapy for these liver failure patients.  With efficient toxin removal and biochemical function, the new high capacity porcine liver slice HepaHope BAL is designed to treat such patients with acute life-threatening liver failure.  Several in vivo studies on animals to evaluate the HepaHope BAL have been conducted.  The efficacy and safety of the device has been examined on animals.  The survival time of eight class A hounds (>50 lbs) with acute liver failure, induced by vascular occlusion, was determined in control or treated dogs using the BAL.  Following separation from whole blood, their plasma was run through the BAL with either empty (4 control) or porcine slice filled (4 treated) cassettes.  Dogs were treated for a total of 6 hours followed by a survival observation period up to 36 hours post occlusion.  Results from the efficacy study demonstrated an average increased survival of 258% (control = 12.8 ± 4 hr, treated = 32.9 ± 6.3 hr; p<0.01).  Averaged clinical biomarkers indicating liver toxicity were substantially improved between control and treated dogs during BAL treatment (e.g. AST=48-62%, ALT=34-47%, total bilirubin=24-39%, lactate= 49-81% of control; p<0.01, except lactate, p<0.05). Production of TNF-alpha, IL-6, MCP-1, C-reactive protein and serum amyloid A was measured. There were no significant differences between control and treated group, suggesting no adverse systemic effects from porcine derived components. The favorable pre-clinical results have encouraged feasibility studies in human patients with acute hepatic failure.