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: George V Mazariegos, John F Patzer 2nd, Roberto C Lopez, Mauricio Giraldo, Michael E Devera, Tracy A Grogan, Yue Zhu, Melissa L Fulmer, Bruce P Amiot, David J Kramer
• Journal: American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons (Am J Transplant) Vol. 2 Issue 3 Pg. 260-6 (Mar 2002) ISSN: 1600-6135 [Print] United States
• PMID: 12096789 (Publication Type: Case Reports, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Hemoglobins
• Serum Albumin
• Lidocaine

Topics

• 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, statistics & numerical data)
• Perfusion
• Safety
• Serum Albumin (analysis)