First clinical use of a novel bioartificial liver support system (BLSS)

Am J Transplant. 2002 Mar;2(3):260-6. doi: 10.1034/j.1600-6143.2002.20311.x.

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.

Publication types

  • Case Reports
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Blood Pressure
  • Erythrocyte Count
  • Female
  • Glasgow Coma Scale
  • Hematocrit
  • Hemoglobins / metabolism
  • Humans
  • International Normalized Ratio
  • Lidocaine / pharmacokinetics
  • Liver Failure / therapy
  • Liver, Artificial / adverse effects
  • Liver, Artificial / statistics & numerical data*
  • Perfusion
  • Safety
  • Serum Albumin / analysis

Substances

  • Hemoglobins
  • Serum Albumin
  • Lidocaine