HepaHope Product Publications

American Society for Artificial Internal Organs (ASAIO)

June 19-21, 2008
San Francisco, USA

How To Improve THe Bio-artificial Liver (BAL) System for Clinical Trials?

Sung-Soo Park1, Jaeho Jung1, Sunny Yang1, Sunnie Kim1, Sam Lee1, Hyoung Yoon1, Young Park1, Nercy Fernandez1, Paul Hernandez1, Nick Haman1, Daren Cox1, Robert Gish2, Brendan McGuire3, Dong-Jin Suh4, Han Chu Lee4

Liver failure is the fifth leading cause of death among 25 to 65 years old within the United States. HepaHope BAL system is an extracorporeal system containing porcine liver slices which was designed to treat liver failure patients as a potential life-saving therapy. For safe and efficient clinical application of BAL system, following parameters should be considered: 1) Flow rate of plasmapheresis, 2) Viable liver mass, 3) Extracorporeal volume, 4) Amount of porcine protein release into patients, 5) Protection from PERV infection, and 6) Pre-clinical efficacy data utilizing a suitable large animal model of acute liver failure. Through careful engineering with cyclic oxygenation and post-treatment filter system, HepaHope BAL system could 1) Increase flow rate range to 50-150 ml/min, 2) Maintain ~80% viable liver mass through a 6 hour treatment time, 3) Reduce extracorporeal volume approximately 50% (1,100 ml to 600 ml), 4) Reduce porcine protein release (~50%), 5) Prevent PERV infection, and 6) Show survival benefit (P<0.05) and improvement of biomarker/physiological parameters (lactate, phosphorous, potassium, pH; P<0.05). These favorable pre-clinical in vitro and in vivo study results have encouraged clinical studies in human patients with liver failure.

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