Van De Kerkhove Maarten-Paul, Di Florio Ernesto, Scuderi Vincenzo, Mancini Antonio, Belli Antonello, Bracco Adele, Scala Daniela, Scala Simona, Zeuli Laura, Di Nicuolo Giuseppe, Amoroso Pietro, Calise Fulvio, Chamuleau Robert A F M
Department of Surgery, Academic Medical Center, University of Amsterdam, The Netherlands.
Liver Transplantation Unit, Department of Surgery, Cardarelli Hospital.
Cell Transplant. 2003 Sep;12(6):563-568. doi: 10.3727/000000003108747163.
Recently a phase I clinical trial has been started in Italy to bridge patients with acute liver failure (ALF) to orthotopic liver transplantation (OLT) by the AMC-bioartificial liver (AMC-BAL). The AMC-BAL is charged with 10 × 109 viable primary porcine hepatocytes isolated from a specified pathogen-free (SPF) pig. Here we report a patient with ALF due to acute HBV infection. This patient was treated for 35 h by two AMC-BAL treatments and was bridged to OLT. There was improvement of biochemical and clinical parameters during the treatment. No severe adverse events were observed during treatment and follow-up of 15 months after hospital discharge. Possible porcine endogenous retrovirus (PERV) activity could not be detected in the patient's blood or blood cells up to 12 months after treatment.
最近，意大利启动了一项I期临床试验，旨在通过AMC生物人工肝（AMC-BAL）将急性肝衰竭（ALF）患者过渡到原位肝移植（OLT）。AMC-BAL接种了从特定无特定病原体（SPF）猪分离出的10×10⁹个活的原代猪肝细胞。在此，我们报告1例因急性HBV感染导致ALF的患者。该患者接受了两次AMC-BAL治疗，时长35小时，并成功过渡到OLT。治疗期间生化和临床参数有所改善。在治疗期间及出院后15个月的随访中未观察到严重不良事件。治疗后长达12个月，在患者血液或血细胞中均未检测到可能的猪内源性逆转录病毒（PERV）活性。
