Access the full text.
Sign up today, get DeepDyve free for 14 days.
N. Shalginskikh, A. Poleshko, A. Skalka, R. Katz (2012)
Retroviral DNA Methylation and Epigenetic Repression Are Mediated by the Antiviral Host Protein DaxxJournal of Virology, 87
R. Valdés‐González, L. Dorantes, E. Bracho-Blanchet, A. Rodríguez-Ventura, White Djg. (2010)
No evidence of porcine endogenous retrovirus in patients with type 1 diabetes after long‐term porcine islet xenotransplantationJournal of Medical Virology, 82
S. Ryder, S. Hawkins, M. Dawson, G. Wells (2000)
The neuropathology of experimental bovine spongiform encephalopathy in the pig.Journal of comparative pathology, 122 2-3
X. Meng (2012)
Emerging and re-emerging swine viruses.Transboundary and emerging diseases, 59 Suppl 1
D. Kaulitz, Debora Mihica, J. Dorna, Michael Costa, B. Petersen, H. Niemann, R. Tönjes, J. Denner (2011)
Development of sensitive methods for detection of porcine endogenous retrovirus-C (PERV-C) in the genome of pigs.Journal of virological methods, 175 1
Syed Haider, Anika Ashok (2009)
Guidance for Industry by U.S. Department of Health and Human Services—Food and Drug Administration—Center for Biologics Evaluation and Research (CBER)—February 1999
S. Tacke, V. Specke, J. Denner (2003)
Differences in Release and Determination of Subtype of Porcine Endogenous Retroviruses Produced by Stimulated Normal Pig Blood CellsIntervirology, 46
S. Wynyard, D. Nathu, O. Garkavenko, J. Denner, R. Elliott (2014)
Microbiological safety of the first clinical pig islet xenotransplantation trial in New ZealandXenotransplantation, 21
Marwan Semaan, A. Rotem, U. Barkai, S. Bornstein, J. Denner (2013)
Screening pigs for xenotransplantation: prevalence and expression of porcine endogenous retroviruses in Göttingen minipigsXenotransplantation, 20
Wei Wang, Z. Mo, B. Ye, P. Hu, Shengyang Liu, S. Yi (2011)
A clinical trial of xenotransplantation of neonatal pig islets for diabetic patients.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences, 36 12
H. Schuurman (2009)
Chapter 2: Source pigsXenotransplantation, 16
J. Novakofski, M. Brewer, N. Mateus-Pinilla, J. Killefer, R. McCusker (2005)
Prion biology relevant to bovine spongiform encephalopathy.Journal of animal science, 83 6
U. Albus (2012)
Guide for the Care and Use of Laboratory Animals (8th edn)Laboratory Animals, 46
Guidance for Industry. Source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans
P. Cochat, L. Vaucoret, J. Sarles (2008)
Et alEvidence Based Mental Health, 11
L. Gazda, Horatiu Vinerean, Melissa Laramore, Richard Hall, J. Carraway, Barry Smith (2014)
No Evidence of Viral Transmission following Long-Term Implantation of Agarose Encapsulated Porcine Islets in Diabetic DogsJournal of Diabetes Research, 2014
Hering (2009)
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Executive summaryXenotransplantation, 16
J. Gombold, Stephen Karakasidis, Paula Niksa, J. Podczasy, Kitti Neumann, J. Richardson, Nandini Sane, R. Johnson-Leva, V. Randolph, J. Sadoff, P. Minor, A. Schmidt, P. Duncan, R. Sheets (2014)
Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products.Vaccine, 32 24
R. Hayden, Z. Gu, J. Ingersoll, Deborah Abdul-Ali, L. Shi, S. Pounds, A. Caliendo (2012)
Comparison of Droplet Digital PCR to Real-Time PCR for Quantitative Detection of CytomegalovirusJournal of Clinical Microbiology, 51
Guideline on xenogenic cell-based medicinal products. IMEA/CHMP/CPWP/83508/2009. 43. 810.213. Verordnung € uber die Transplantation von tierischen Organen
P. Hedlin, Ryan Taschuk, A. Potter, P. Griebel, S. Napper (2012)
Detection and Control of Prion Diseases in Food AnimalsISRN Veterinary Science, 2012
S. Wynyard, O. Garkavenko, R. Elliot (2011)
Multiplex high resolution melting assay for estimation of Porcine Endogenous Retrovirus (PERV) relative gene dosage in pigs and detection of PERV infection in xenograft recipients.Journal of virological methods, 175 1
Jie-mei Yu, Jin-song Li, Yuan-yun Ao, Z. Duan (2013)
Detection of novel viruses in porcine fecal samples from ChinaVirology Journal, 10
G. Wells, S. Hawkins, A. Austin, S. Ryder, S. Done, R. Green, I. Dexter, M. Dawson, R. Kimberlin (2003)
Studies of the transmissibility of the agent of bovine spongiform encephalopathy to pigs.The Journal of general virology, 84 Pt 4
N. Mueller, Y. Takeuchi, G. Mattiuzzo, L. Scobie (2011)
Microbial safety in xenotransplantationCurrent Opinion in Organ Transplantation, 16
N. Hunter (2003)
Scrapie and experimental BSE in sheep.British medical bulletin, 66
(2010)
Federation of Animal Science Societies. The Guide for the Care and Use of Agricultural Animals in Research and Teaching
Arifa Khan (2011)
Current Testing Methods and Challenges for Detection of Adventitious VirusesPDA Journal of Pharmaceutical Science and Technology, 65
Christopher Hindson, J. Chevillet, H. Briggs, E. Gallichotte, I. Ruf, B. Hindson, R. Vessella, M. Tewari (2013)
Absolute quantification by droplet digital PCR versus analog real-time PCRNature methods, 10
Merck Veterinary Manual, 10th edn
J. Foster, William McKelvey, H. Fraser, Angie Chong, Arlene Ross, D. Parnham, W. Goldmann, Nora Hunter (1999)
Experimentally induced bovine spongiform encephalopathy did not transmit via goat embryos.The Journal of general virology, 80 ( Pt 2)
F. Segundo, F. Salguero, A. Avila, J. Espinosa, J. Torres, A. Brun (2006)
Distribution of the cellular prion protein (PrPC) in brains of livestock and domesticated speciesActa Neuropathologica, 112
(2012)
SCOBIE L, TAKEUCHI Y
A. Lubiniecki (2011)
Evolution of Approaches to Viral Safety Issues for Biological ProductsPDA Journal of Pharmaceutical Science and Technology, 65
(2003)
SPECKE V, DENNER J
M. Matoušková, P. Veselý, P. Daniel, G. Mattiuzzo, R. Hector, L. Scobie, Y. Takeuchi, J. Hejnar (2013)
Role of DNA Methylation in Expression and Transmission of Porcine Endogenous RetrovirusesJournal of Virology, 87
(2000)
DAWSON M, WELLS GA
(2012)
RAMIREZ A, SCHWARTZ KJ, STEVENSON GW
Britta Dieckhoff, B. Kessler, D. Jobst, W. Kues, B. Petersen, A. Pfeifer, R. Kurth, H. Niemann, E. Wolf, J. Denner (2008)
Distribution and expression of porcine endogenous retroviruses in multi‐transgenic pigs generated for xenotransplantationXenotransplantation, 16
C. Heath, R. Barker, T. Esmonde, P. Harvey, R. Roberts, P. Trend, M. Head, Colin Smith, J. Bell, J. Ironside, R. Will, R. Knight (2006)
Dura mater-associated Creutzfeldt–Jakob disease: experience from surveillance in the UKJournal of Neurology, Neurosurgery & Psychiatry, 77
B. Tag, Martin Böse (2009)
Das Bundesgesetz über die Transplantation von Organen, Geweben und Zellen - die schweizerische Rechtslage zur Transplantationsmedizin
(2012)
Diseases of Swine, 10th edn
J. Denner, R. Tönjes (2012)
Infection Barriers to Successful Xenotransplantation Focusing on Porcine Endogenous RetrovirusesClinical Microbiology Reviews, 25
M. Köfler, T. Seuberlich, E. Maurer, D. Heim, M. Doherr, A. Zurbriggen, C. Botteron (2006)
[TSE surveillance in small ruminants and pigs: a pilot study].Schweizer Archiv fur Tierheilkunde, 148 7
J. Fishman, L. Scobie, Y. Takeuchi (2012)
Xenotransplantation‐associated infectious risk: a WHO consultationXenotransplantation, 19
L. Gazda, Horatiu Vinerean, Melissa Laramore, C. Diehl, Richard Hall, A. Rubin, Barry Smith (2007)
Encapsulation of Porcine Islets Permits Extended Culture Time and Insulin Independence in Spontaneously Diabetic BB RatsCell Transplantation, 16
(2011)
TAKEUCHI Y, MATTIUZZO G, SCOBIE L
L. Scobie, Vered Padler-Karavani, S. Bas-Bernardet, C. Crossan, J. Blaha, M. Matoušková, R. Hector, E. Cozzi, B. Vanhove, B. Charreau, G. Blancho, L. Bourdais, M. Tallacchini, J. Ribes, Hai Yu, Xi Chen, J. Kracikova, L. Brož, J. Hejnar, P. Veselý, Y. Takeuchi, A. Varki, J. Soulillou (2013)
Long-Term IgG Response to Porcine Neu5Gc Antigens without Transmission of PERV in Burn Patients Treated with Porcine Skin XenograftsThe Journal of Immunology, 191
K. Takemura, M. Kahdre, D. Joseph, A. Yousef, S. Sreevatsan (2004)
An overview of transmissible spongiform encephalopathiesAnimal Health Research Reviews, 5
B. Hering, E. Cozzi, T. Spizzo, P. Cowan, G. Rayat, D. Cooper, J. Denner (2016)
First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes—Executive summaryXenotransplantation, 23
Chapter 2 of the original consensus statement published in 2009 by IXA represents an excellent basis for the production of safe donor pigs and pig‐derived materials for porcine islet xenotransplantation. It was intended that the consensus statement was to be reviewed at interval to remain relevant. Indeed, many of the original salient points remain relevant today, especially when porcine islet xenotransplantation is performed in conjunction with immunosuppressants. However, progress in the field including demonstrated safe clinical porcine xenograft studies, increased understanding of risks including those posed by PERV, and advancement of diagnostic capabilities now allow for further consideration. Agents of known and unknown pathogenic significance continue to be identified and should be considered on a geographic, risk‐based, dynamic, and product‐specific basis, where appropriate using validated, advanced diagnostic techniques. PERV risk can be sufficiently reduced via multicomponent profiling including subtype expression levels in combination with infectivity assays. Barrier facilities built and operated against the AAALAC Ag Guide or suitable alternative criteria should be considered for source animal production as long as cGMPs and SOPs are followed. Bovine material‐free feed for source animals should be considered appropriate instead of mammalian free materials to sufficiently reduce TSE risks. Finally, the sponsor retention period for archival samples of donor materials was deemed sufficient until the death of the recipient if conclusively determined to be of unrelated and non‐infectious cause or for a reasonable period, that is, five to 10 yrs. In summary, the safe and economical production of suitable pigs and porcine islet xenograft materials, under appropriate guidance and regulatory control, is believed to be a viable means of addressing the unmet need for clinical islet replacement materials.
Xenotransplantation – Wiley
Published: Jan 1, 2016
Keywords: ; ; ; ; ; ; ; ; ;
Read and print from thousands of top scholarly journals.
Already have an account? Log in
Bookmark this article. You can see your Bookmarks on your DeepDyve Library.
To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.
Copy and paste the desired citation format or use the link below to download a file formatted for EndNote
Access the full text.
Sign up today, get DeepDyve free for 14 days.
All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.