First clinical use of a novel bioartificial liver support system (BLSS).
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.
Mazariegos
George V
GV
Thomas E Starzl Transplantation Institute, Department of Surgery, University of Pittsburgh, PA, USA.
Patzer
John F
JF
Lopez
Roberto C
RC
Giraldo
Mauricio
M
Devera
Michael E
ME
Grogan
Tracy A
TA
Zhu
Yue
Y
Fulmer
Melissa L
ML
Amiot
Bruce P
BP
Kramer
David J
DJ
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
D006454:Hemoglobins; D012709:Serum Albumin; D008012:Lidocaine