title: Phase I clinical trial with the AMC-bioartificial liver.
abstract: 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.
  
  
  CONCLUSIONS
  Treatment of ALF patients with the AMC-BAL is a safe and feasible technique to bridge the waiting time for an adequate liver-graft.
authors.affiliation: Surgical Laboratory, Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. m.p.vandekerkhove@amc.uva.nl
authors.forename: M P
authors.initials: MP
authors.lastname: van de Kerkhove
authors.forename: E
authors.initials: E
authors.lastname: Di Florio
authors.forename: V
authors.initials: V
authors.lastname: Scuderi
authors.forename: A
authors.initials: A
authors.lastname: Mancini
authors.forename: A
authors.initials: A
authors.lastname: Belli
authors.forename: A
authors.initials: A
authors.lastname: Bracco
authors.forename: M
authors.initials: M
authors.lastname: Dauri
authors.forename: G
authors.initials: G
authors.lastname: Tisone
authors.forename: G
authors.initials: G
authors.lastname: Di Nicuolo
authors.forename: P
authors.initials: P
authors.lastname: Amoroso
authors.forename: A
authors.initials: A
authors.lastname: Spadari
authors.forename: G
authors.initials: G
authors.lastname: Lombardi
authors.forename: R
authors.initials: R
authors.lastname: Hoekstra
authors.forename: F
authors.initials: F
authors.lastname: Calise
authors.forename: R A F M
authors.initials: RA
authors.lastname: Chamuleau
mesh_terms: D000328:Adult; D005112:Extracorporeal Circulation; D005260:Female; D006801:Humans; D017114:Liver Failure, Acute / Q000628:therapy*; D016031:Liver Transplantation; D019164:Liver, Artificial / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D014850:Waiting Lists