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Excorp Medical's Bioartificial Liver System comprises a reusable instrument, disposable tubing set and the proprietary, disposable bioartificail reactor.Once approved by regulatory agencies, Excorp Medical expects this breakthrough Bioartificial Liver System technology to be both live-saving and cost effective.Certain drugs or machines are available to substitute temporarily or long-term for many organs in the body…  no comparable substitute has been developed for the liver.The liver is the largest organ in the body and performs a variety of tasks impacting all body systems… as a result liver disease has widespread effects on virtually all other organs.Excorp Medical is currently the only company approved to conduct bioartificial liver human trials within the U.S.Currently patients must receive a liver transplant or endure prolonged hospitalization at great expense to have a chance at survival.Excorp Medical Bioartificial Liver System treatments serve as a bridge to liver regeneration and transplantExcorp Medical has developed a Bioartificial Liver System for the metabolic support of patients with compromised liver function.
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Pre-clinical Evaluation of Bioartificial Liver Support System
Plasma versus Whole Blood Perfusion
First Clinical Use of a Novel Bioartificial Liver Support
Clinical and laboratory evaluation of the safety
Bound Dilute Analysis
Oxygen Consumption in a Hollow Fiber Bioartificial Liver - Revisited

Clinical and laboratory evaluation of the safety of a bioartificial liver assist device for potential transmission of porcine endogenous retrovirus


Published in Transplantation 2002 Lippincott Williams & Wilkins, Inc.
By: Kuddus, R.; Patzer, J.J. II.; Lopez, R.; Mazariegos, G.V.; Meighen, B.; Kramer, D.J.; Rao, A.S.

Abstract

Background. The potential risk of transmission of porcine endogenous retroviruses (PERV) from xenogeneic donors into humans has been widely debated. Because we were involved in a phase I/II clinical trial using a bioartificial liver support system (BLSS), we proceeded to evaluate the biosafety of this device.

Materials and Methods. The system being evaluated contains primary porcine hepatocytes freshly isolated from pathogen-free, purpose-raised herd. Isolated hepatocytes were installed in the shell, which is separated by a semipermeable membrane (100 kD nominal cutoff) from the lumen through which the patients' whole blood is circulated. Both before and at defined intervals posthemoperfusion, patients' blood was obtained for screening. Additionally, effluent collected from a clinical bioreactor was analyzed. The presence of viral particles was estimated by reverse transcriptase polymerase chain reaction (RT-PCR) and RT assays. For the detection of pig genomic and mitochondrial DNA, sequence-specific PCR (SS-PCR) was used. Finally, the presence of infectious viral particles in the samples was ascertained by exposure to the PERV-susceptible human cell line HEK-293.

Results. PERV transcripts, RT activity, and infectious PERV particles were not detected in the luminal effluent of a bioreactor. Culture supernatant from untreated control or mitogen-treated porcine hepatocytes (cleared of cellular debris) also failed to infect HEK-293 cell lines. Finally, RT-PCR, SS-PCR, and PERV-specific RT assay detected no PERV infection in the blood samples obtained from five study patients both before and at various times post-hemoperfusion.

Conclusion. Although longer patient follow-up is required and mandated to unequivocally establish the biosafety of this device and related bioartificial organ systems, these analyses support the conclusion that when used under standard operational conditions, the BLSS is safe.

Published in Transplantation 2002 Lippincott Williams & Wilkins, Inc. By: Kuddus, R.; Patzer, J.J. II.; Lopez, R.; Mazariegos, G.V.; Meighen, B.; Kramer, D.J.; Rao, A.S.

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