The HepatAssist bioartificial liver support system: clinical study and pig hepatocyte process

Abstract

Based on perfusion of patient plasma through a circuit incorporating a hollow fibre membrane cartridge containing porcine hepatocytes, a bioartificial support system, or HepatAssist System, has been developed. Thirty-nine patients with acute liver failure (ALF) were treated in a Phase I multicentre clinical study. Thirty-two patients were bridged to orthotopic liver transplantation and six patients recovered without requiring a graft. Patient survival rate at one month was 90%. On the basis of these results, a multicentre Phase II/III, randomised, controlled, parallel group study of the HepatAssist System, compared to standard care in ALF patients has been initiated.