Journal article
Clinical and laboratory evaluation of the safety of a bioartificial liver assist device for potential transmission of porcine endogenous retrovirus
Transplantation, v 73(3), pp 420-429
2002
PMID: 11884940
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
Metrics
Details
- Title
- Clinical and laboratory evaluation of the safety of a bioartificial liver assist device for potential transmission of porcine endogenous retrovirus
- Creators
- R Kuddus - University of PittsburghJ. F Patzer - University of PittsburghR Lopez - University of PittsburghG. V Mazariegos - University of PittsburghB Meighen - University of PittsburghD. J Kramer - University of PittsburghA. S Rao - Hahnemann University Hospital
- Publication Details
- Transplantation, v 73(3), pp 420-429
- Publisher
- Lippincott
- Number of pages
- 10
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Microbiology and Immunology
- Web of Science ID
- WOS:000174115400017
- Scopus ID
- 2-s2.0-0037083865
- Other Identifier
- 991019167763104721
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InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Immunology
- Surgery
- Transplantation