Phase I clinical trial with the AMC-bioartificial liver

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...

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Veröffentlicht in:International journal of artificial organs 2002-10, Vol.25 (10), p.950-959
Hauptverfasser: 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
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container_end_page 959
container_issue 10
container_start_page 950
container_title International journal of artificial organs
container_volume 25
creator 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
description 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.
doi_str_mv 10.1177/039139880202501009
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source MEDLINE; SAGE Complete
subjects Adult
Extracorporeal Circulation
Female
Humans
Liver Failure, Acute - therapy
Liver Transplantation
Liver, Artificial - adverse effects
Male
Middle Aged
Waiting Lists
title Phase I clinical trial with the AMC-bioartificial liver
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