title: First clinical use of a novel bioartificial liver support system (BLSS).
abstract: The first clinical use of the Excorp Medical Bioartificial Liver Support System (BLSS) in support of a 41-year-old African-American female with fulminant hepatic failure is described. The BLSS is currently in a Phase I/II safety evaluation at the University of Pittsburgh/UPMC System. Inclusion criteria for the study are patients with acute liver failure, any etiology, presenting with encephalopathy deteriorating beyond Parson's Grade 2. The BLSS consists of a blood pump; a heat exchanger to control blood temperature; an oxygenator to control oxygenation and pH; a bioreactor; and associated pressure and flow alarm systems. Patient liver support is provided by 70-100 g of porcine liver cells housed in the hollow fiber bioreactor. The patient exhibited transient hypotension and thrombocytopenia at initiation of perfusion. The only unanticipated safety event was a lowering of patient glucose level at the onset of perfusion with the BLSS that was treatable with intravenous glucose administration. Moderate changes in blood biochemistries pre- and post perfusion are indicative of liver support being provided by the BLSS. While the initial experience with the BLSS is encouraging, completion of the Phase I/II study is required in order to more fully understand the safety aspects of the BLSS.
authors.affiliation: Thomas E Starzl Transplantation Institute, Department of Surgery, University of Pittsburgh, PA, USA.
authors.forename: George V
authors.initials: GV
authors.lastname: Mazariegos
authors.forename: John F
authors.initials: JF
authors.lastname: Patzer
authors.forename: Roberto C
authors.initials: RC
authors.lastname: Lopez
authors.forename: Mauricio
authors.initials: M
authors.lastname: Giraldo
authors.forename: Michael E
authors.initials: ME
authors.lastname: Devera
authors.forename: Tracy A
authors.initials: TA
authors.lastname: Grogan
authors.forename: Yue
authors.initials: Y
authors.lastname: Zhu
authors.forename: Melissa L
authors.initials: ML
authors.lastname: Fulmer
authors.forename: Bruce P
authors.initials: BP
authors.lastname: Amiot
authors.forename: David J
authors.initials: DJ
authors.lastname: Kramer
mesh_terms: D000328:Adult; D001794:Blood Pressure; D004906:Erythrocyte Count; D005260:Female; D015600:Glasgow Coma Scale; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D019934:International Normalized Ratio; D008012:Lidocaine / Q000493:pharmacokinetics; D017093:Liver Failure / Q000628:therapy; D019164:Liver, Artificial / Q000009:adverse effects / Q000706:statistics & numerical data*; D010477:Perfusion; D012449:Safety; D012709:Serum Albumin / Q000032:analysis
chemical_list: D006454:Hemoglobins; D012709:Serum Albumin; D008012:Lidocaine