About: A comprehensive microbiological safety approach for agarose encapsulated porcine islets intended for clinical trials

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About: A comprehensive microbiological safety approach for agarose encapsulated porcine islets intended for clinical trials Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	A comprehensive microbiological safety approach for agarose encapsulated porcine islets intended for clinical trials
Creator	Marthaler, Douglas Collins, James Gazda, Lawrence Laramore, Melissa Smith, H Vinerean, Horatiu Hall, D Galbraith, Daniel Richard, \| Barry, \| Black, John Deborah Hoffer, \| Euan, \| Graham, Melanie Holdcraft, Robert Lovatt, \| Maclean, Christine Merribeth, \| Michalak, Michelle Milne, W Morin, J Richter, Steven
source	Medline; PMC
abstract	BACKGROUND: The use of porcine islets to replace insulin‐producing islet β‐cells, destroyed during the diabetogenic disease process, presents distinct challenges if this option is to become a therapeutic reality for the treatment of type 1 diabetes. These challenges include a thorough evaluation of the microbiological safety of the islets. In this study, we describe a robust porcine islet‐screening program that provides a high level of confidence in the microbiological safety of porcine islets suitable for clinical trials. METHODS: A four‐checkpoint program systematically screens the donor herd (Large White – Yorkshire × Landrace F1 hybrid animals), individual sentinel and pancreas donor animals and, critically, the islet macrobeads themselves. Molecular assays screen for more than 30 known viruses, while electron microscopy and in vitro studies are employed to screen for potential new or divergent (emergent) viruses. RESULTS: Of 1207 monthly samples taken from random animals over a 2‐year period, only a single positive result for Transmissible gastroenteritis virus was observed, demonstrating the high level of biosecurity maintained in the source herd. Given the lack of clinical signs, positive antibody titers for Porcine reproductive and respiratory syndrome virus, Porcine parvovirus, and Influenza A confirm the efficacy of the herd vaccination program. Porcine respiratory coronavirus was found to be present in the herd, as expected for domestic swine. Tissue homogenate samples from six sentinel and 11 donor animals, over the same 2‐year period, were negative for the presence of viruses when co‐cultured with six different cell lines from four species. The absence of adventitious viruses in separate islet macrobead preparations produced from 12 individual pancreas donor animals was confirmed using validated molecular (n = 32 viruses), in vitro culture (cells from four species), and transmission electron microscopy assays (200 cell profiles per donor animal) over the same 2‐year period. There has been no evidence of viral transmission following the implantation of these same encapsulated and functional porcine islets into non‐immunosuppressed diabetic cynomolgus macaques for up to 4 years. Isolated peripheral blood mononuclear cells from all time points were negative for PCV (Type 2), PLHV, PRRSV, PCMV, and PERV‐A, PERV‐B, and PERV‐C by PCR analysis in all six recipient animals. CONCLUSION: The four‐checkpoint program is a robust and reliable method for characterization of the microbiological safety of encapsulated porcine islets intended for clinical trials.
has issue date	2016-11-11(xsd:dateTime)
bibo:doi	10.1111/xen.12277
bibo:pmid	27862363
has license	cc-by-nc-nd
sha1sum (hex)	f9cb7666b0c0ba3ad39d782a78d4fcd97d235176
schema:url	https://doi.org/10.1111/xen.12277
resource representing a document's title	A comprehensive microbiological safety approach for agarose encapsulated porcine islets intended for clinical trials
has PubMed Central identifier	PMC7169751
has PubMed identifier	27862363
schema:publication	Xenotransplantation
resource representing a document's body	covid:f9cb7666b0c0ba3ad39d782a78d4fcd97d235176#body_text
is schema:about of	named entity 'islets' named entity 'islet' named entity 'porcine' named entity 'islets' covid:arg/f9cb7666b0c0ba3ad39d782a78d4fcd97d235176 named entity 'islets' named entity 'viral particle' named entity 'Landrace' named entity 'anemia' named entity 'adverse events' named entity 'insulin' named entity 'safety' named entity 'encapsulated' named entity 'diabetogenic' named entity 'clinical trials' named entity 'microbiological safety' named entity 'agarose' named entity 'clinical trials' named entity 'robust' named entity 'islet transplantation' named entity 'lymph node' named entity 'xenotransplantation' named entity 'FDA' named entity 'islet cells' named entity 'Agarase' named entity 'islet cells' named entity 'multivesicular body' named entity 'immunosuppression' named entity 'glucose' named entity 'exogenous' named entity 'nucleic acid' named entity 'edema' named entity 'non-human primates' named entity 'hypoglycemic' named entity 'porcine' named entity 'gestation' named entity 'cytokines' named entity 'mitotic' named entity 'bacteriophage' named entity 'organelles' named entity 'cytoplasm' named entity 'animal tissue' named entity 'zoonotic' named entity 'porcine' named entity 'pre-clinical' named entity 'protein' named entity 'corn' named entity 'porcine' named entity 'pancreas' named entity 'pathogens' named entity 'mycotic' named entity 'Quality Assurance' named entity 'pancreatic islets' named entity 'PERV' named entity 'porcine' named entity 'porcine' named entity 'Large White' named entity 'blood glucose regulation' named entity 'receptor' named entity 'pork'

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