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.

Problems and prospects of creation of extracorporal systems for support of functional livers status

“…Система MELS, разработанная в клинике Charite Virchow (Берлин, Германия) состоит из биореактора (CellModule) с гепатоцитами свиней или человека, детоксикационного блока (DetoxModule) на основе альбуминового диализа и диализного модуля (DialysisModule) для осуществления длительной вено-венозной гемодиафильтрации [87,121,122]. Гепатоциты (500-600 г) фиксируются в 3D матриксе, состоящем из двух групп гидрофильного материала для транспорта плазмы и группы гидрофобных волокон для поставки кислорода и удаления углекислого газа.…”

Akutes Leberversagen

“…Zwei Zentren haben das HepatAssist-System zum Bridging bis zur Transplantation eingesetzt [63,64].Die von Demetriou in Los Angeles entwickelte Bioartificial Liver (BAL) trug bei 16 von 17 Patienten zum erfolgreichen Bridging bis zur Lebertransplantation bei [65]. Aus Pittsburgh wurde über einen positiven Einsatz des Bioartificial Liver Support System (BLSS) an einem Patienten berichtet [66]. …”

Current development of bioreactors for extracorporeal bioartificial liver (Review)

“…The first case of treatment with BLSS is a 4l-yearold female patient with ALF. 155 After treatment, the patient had the concentrations of ammonia, lactate, and total bilirubin decreased, coagulation function and clinical symptoms improved, and eventually removed off the BLSS treatment. There was another study that reported four cases with ALF treated with BLSS.…”