Phase I clinical trial with the AMC-bioartificial liver - PubMed
Clinical Trial
doi: 10.1177/039139880202501009.
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
Affiliations
- PMID: 12456036
- DOI: 10.1177/039139880202501009
Clinical Trial
Phase I clinical trial with the AMC-bioartificial liver
M P van de Kerkhove et al. Int J Artif Organs. 2002 Oct.
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.
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