Phase I clinical trial with the AMC-bioartificial liver

M. P. van de Kerkhove; E. Di Florio; V. Scuderi; A. Mancini; A. Belli; A. Bracco; M. Dauri; G. Tisone; G. Di Nicuolo; P. Amoroso; A. Spadari; G. Lombardi; R. Hoekstra; F. Calise; R. A. F. M. Chamuleau

Phase I clinical trial with the AMC-bioartificial liver

M. P. van de Kerkhove
, E. Di Florio
, V. Scuderi
, A. Mancini
, A. Belli
, A. Bracco
, M. Dauri
, G. Tisone
, G. Di Nicuolo
, P. Amoroso
, A. Spadari
, G. Lombardi
, R. Hoekstra
, F. Calise
, R. A. F. M. Chamuleau

Research output: Contribution to journal › Article › Academic › peer-review

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. Conclusion: Treatment of ALF patients with the AMC-BAL is a safe and feasible technique to bridge the waiting time for an adequate liver-graft

Original language	English
Pages (from-to)	950-959
Journal	International journal of artificial organs
Volume	25
Issue number	10
Publication status	Published - 2002

Cite this

@article{8f46998337ec4fea9488b2ba53ece8e4,

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. Conclusion: Treatment of ALF patients with the AMC-BAL is a safe and feasible technique to bridge the waiting time for an adequate liver-graft",

author = "\{van de Kerkhove\}, \{M. P.\} and \{Di Florio\}, E. and V. Scuderi and A. Mancini and A. Belli and A. Bracco and M. Dauri and G. Tisone and \{Di Nicuolo\}, G. and P. Amoroso and A. Spadari and G. Lombardi and R. Hoekstra and F. Calise and Chamuleau, \{R. A. F. M.\}",

year = "2002",

language = "English",

volume = "25",

pages = "950--959",

journal = "International journal of artificial organs",

issn = "0391-3988",

publisher = "Wichtig Publishing",

number = "10",

}

TY - JOUR

T1 - Phase I clinical trial with the AMC-bioartificial liver

AU - van de Kerkhove, M. P.

AU - Di Florio, E.

AU - Scuderi, V.

AU - Mancini, A.

AU - Belli, A.

AU - Bracco, A.

AU - Dauri, M.

AU - Tisone, G.

AU - Di Nicuolo, G.

AU - Amoroso, P.

AU - Spadari, A.

AU - Lombardi, G.

AU - Hoekstra, R.

AU - Calise, F.

AU - Chamuleau, R. A. F. M.

PY - 2002

Y1 - 2002

N2 - 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. Conclusion: Treatment of ALF patients with the AMC-BAL is a safe and feasible technique to bridge the waiting time for an adequate liver-graft

AB - 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. Conclusion: Treatment of ALF patients with the AMC-BAL is a safe and feasible technique to bridge the waiting time for an adequate liver-graft

M3 - Article

C2 - 12456036

SN - 0391-3988

VL - 25

SP - 950

EP - 959

JO - International journal of artificial organs

JF - International journal of artificial organs

IS - 10

ER -

Phase I clinical trial with the AMC-bioartificial liver

Abstract

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