Functional evaluation of the AMC-BAL to be employed in a multicentric clinical trial for acute liver failure

Calise, Fulvio; Mancini, Antonio; Amoroso, P; Belli, Antonello; Bracco, Adele; Ceriello, Antonio; Florio, E. Di; Nicuolo, Giuseppe Di; Martino, Annamaria; Maida, Paola; Scala, Daniela; Zeuli, Laura; Chamuleau, R. A. F. M.

doi:10.1016/s0041-1345(00)02183-7

Cited by 8 publications

(6 citation statements)

References 8 publications

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“…It should, however, be taken into account that cold preservation causes loss of hepatocyte function inside the bioreactor. 118 Alternatively, the hepatocyte-loaded bioreactor can be perfused and oxygenated under (sub)normothermic conditions during transport. Under normothermic (37°C) conditions, cell function of the hepatocytes will stabilize as much as possible and will be comparable to that of a laboratory culture of the cells in the bioreactor.…”

Section: Bioactive Mass and Source Of Hepatocytesmentioning

confidence: 99%

Clinical Application of Bioartificial Liver Support Systems

et al. 2004

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Section: Bioactive Mass and Source Of Hepatocytesmentioning

confidence: 99%

Clinical Application of Bioartificial Liver Support Systems

et al. 2004

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“…In general there are two options to provide the hospitalized patient with a BAL system: (1) transportation of an empty bioreactor separate from the hepatocytes (which are usually cryopreserved in stock) and charging the BAL on demand in the local hospital [26, 27], or (2) assembling the bioreactor in a specialized laboratory and transport the charged BAL to the patient on demand [28,29,30]. …”

Section: Logistics Of Bal Treatmentmentioning

confidence: 99%

“…One option is to transport the cell loaded bioreactor in an organ preservation solution at 4°C. However, transport of a cold preserved BAL system in Celsior negatively affects cell viability and hepatocyte-specific functions [28,29,30]. An alternative is to transport the BAL system under oxygenation and medium perfusion at (sub)normothermic temperatures.…”

Section: Logistics Of Bal Treatmentmentioning

confidence: 99%

Liver Support Therapy: An Overview of the AMC-Bioartificial Liver Research

Kerkhove¹,

Poyck²,

Deurholt³

et al. 2005

Dig Surg

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Acute liver failure (ALF) is a disease with a mortality of 60–90% depending on the cause. Only high-urgency liver transplantation is able to increase survival compared to standard intensive care therapy. Liver transplantation is hampered by the increasing shortage of organ donors, resulting in a high incidence of patients with ALF dying on the transplantation waiting list. Amongst a variety of liver assist therapies, bioartificial liver (BAL) therapy is marked as the most promising solution to bridge ALF patients to liver transplantation or to liver regeneration, since several BAL systems showed significant improvement of survival time in experimental animals with irreversible ALF. One of these systems has been developed at the Academic Medical Center in Amsterdam, The Netherlands – the AMC-BAL. This overview describes the development of the AMC-BAL based on porcine hepatocytes which was started 10 years ago. Positive results of in vitrofunctionality and in vivo safety and efficacy led to a successful phase I study in 12 ALF patients in Italy. However, xenotransplantation legislation in many European countries prohibits the use of porcine hepatocytes in clinically applied BAL systems. The future of the BAL, therefore, resides in the development of a human-derived hepatocyte cell line as biocomponent of BAL systems.

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“…Several bioartificial liver devices that differ substantially in both the hepatocyte component and bioreactor design have been assessed either experimentally or clinically [51][52][53][54]55]. Most clinical experience is with the "HepatAssist" (Circe Biomedical, Lexington, MA) bioartificial liver support system which contains cryopreserved porcine hepatocytes as the cellular component and charcoal haemoperfusion [55].…”

Section: Extracorporeal Liver Supportmentioning

confidence: 99%

“…• A number of extracorporeal devices have been developed and are currently undergoing clinical trial as potential alternatives to auxiliary partial OLT for providing temporary liver support (artificial or bioartificial) in FHF [51][52][53][54][55]. Clinical efficacy remains to be established.…”

Section: Orthotopic Liver Transplantationmentioning

confidence: 99%

Fulminant hepatic failure

Kurtovic

Riordan

Williams

2005

Curr Treat Options Gastro

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The rare but potentially devastating clinical syndrome of fulminant hepatic failure has as its components severe encephalopathy and finally cerebral edema, hemodynamic instability, renal failure, coagulopathy, profound metabolic disturbances and a particular susceptibility to bacterial and fungal infection. Despite advances in medical management, fulminant hepatic failure in its most severe form carries a high mortality rate unless urgent orthotopic liver transplantation is carried out. However, availability of cadaveric donor organs is limited and, due to the rapidly progressive clinical course in many cases, a substantial proportion of patients will die or develop contraindications to transplantation before the procedure can be performed. Consequently, recent interest has centred on living donor transplantation and the possibility of providing temporary liver support, either through auxiliary partial organ transplantation, extracorporeal perfusion or transplantation of hepatocytes, to allow time for either a liver graft to become available or native liver regeneration, on which spontaneous survival ultimately depends, to occur.

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Functional evaluation of the AMC-BAL to be employed in a multicentric clinical trial for acute liver failure

Cited by 8 publications

References 8 publications

Clinical Application of Bioartificial Liver Support Systems

Clinical Application of Bioartificial Liver Support Systems

Liver Support Therapy: An Overview of the AMC-Bioartificial Liver Research

Fulminant hepatic failure

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