Phase I clinical trial with the AMC-bioartificial liver

• Published in: International journal of artificial organs Vol. 25; no. 10; p. 950
• Main Authors: van de Kerkhove, M P, Di Florio, E, Scuderi, V, Mancini, A, Belli, A, Bracco, A, Dauri, M, Tisone, G, Di Nicuolo, G, Amoroso, P, Spadari, A, Lombardi, G, Hoekstra, R, Calise, F, Chamuleau, R A F M
• Format: Journal Article
• Language: English
• Published: United States 01.10.2002
• Subjects: Adult; Extracorporeal Circulation; Female; Humans; Liver Failure, Acute - therapy; Liver Transplantation; Liver, Artificial - adverse effects; Male; Middle Aged; Waiting Lists
• ISSN: 0391-3988
• DOI: 10.1177/039139880202501009

Recently a bio-artificial liver (BAL) system has been developed at the Academic Medical Center (AMC) of Amsterdam to bridge patients with acute liver failure (ALF) to orthotopic liver transplantation (OLT). After successful testing of the AMC-BAL in rodents and pigs with ALF, a phase I study in ALF patients waiting for (OLT) was started in Italy. We present the safety outcome of the first 7 patients aged 21-56 years with coma grade III or IV The total AMC-BAL treatment time ranged from 8 to 35 hours. Three patients received 2 treatments with two different BAL's within three days. Six of the 7 patients were successfully bridged to OLT. One patient showed improved liver function after two treatments and did not need OLT. No severe adverse events of the BAL treatment were noted. Treatment of ALF patients with the AMC-BAL is a safe and feasible technique to bridge the waiting time for an adequate liver-graft.