Journal
INTERNATIONAL JOURNAL OF ARTIFICIAL ORGANS
Volume 25, Issue 10, Pages 950-959Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/039139880202501009
Keywords
acute liver failure; bioartificial liver; liver transplantation; hepatocyte; human; porcine; clinical trial; safety
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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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