The HepatAssist bioartificial liver support system: clinical study and pig hepatocyte process.
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.
Circe Biomedical, Inc., 99 Hayden Avenue, Lexington, MA 02421-7995, USA. mullon@circebio.com
C
C
Mullon
Z
Z
Pitkin