Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand
Abstract Background Xenotransplantation using pig cells, tissues, or organs may be associated with the transmission of porcine microorganisms and the development of zoonoses. Among all porcine microorganisms porcine endogenous retroviruses ( PERV s) represent a special risk because they are integrat...
Published in: | Xenotransplantation |
---|---|
Main Authors: | , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
Wiley
2014
|
Subjects: | |
Online Access: | http://dx.doi.org/10.1111/xen.12102 https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fxen.12102 https://onlinelibrary.wiley.com/doi/pdf/10.1111/xen.12102 |
id |
crwiley:10.1111/xen.12102 |
---|---|
record_format |
openpolar |
spelling |
crwiley:10.1111/xen.12102 2024-06-23T07:51:26+00:00 Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand Wynyard, Shaun Nathu, Divya Garkavenko, Olga Denner, Joachim Elliott, Robert 2014 http://dx.doi.org/10.1111/xen.12102 https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fxen.12102 https://onlinelibrary.wiley.com/doi/pdf/10.1111/xen.12102 en eng Wiley http://onlinelibrary.wiley.com/termsAndConditions#vor Xenotransplantation volume 21, issue 4, page 309-323 ISSN 0908-665X 1399-3089 journal-article 2014 crwiley https://doi.org/10.1111/xen.12102 2024-06-13T04:23:37Z Abstract Background Xenotransplantation using pig cells, tissues, or organs may be associated with the transmission of porcine microorganisms and the development of zoonoses. Among all porcine microorganisms porcine endogenous retroviruses ( PERV s) represent a special risk because they are integrated in the genome of all pigs and able to infect human cells. In previous preclinical and retrospective clinical trials of xenotransplantation, no transmission of PERV was observed. The first clinical trial of (alginate‐encapsulated) porcine islet cell transplantation in New Zealand, which was approved by the New Zealand Government as an open‐label phase I/ II a safety/efficacy trial, offers the possibility to analyze microbiological safety in a prospective clinical study. Methods Before the trial started, a multilevel testing strategy was used to screen for 26 microorganisms in donor pigs of the Auckland Island strain and the islet cell preparations used for treatment. Donor testing was performed using molecular methods including multiplex real‐time PCR . Blood samples from 14 pig islet cell recipients were also investigated by molecular biological methods at weeks 1, 4, 8, 12, 24, and 52 post‐transplant for the transmission of porcine microorganisms. Sera were also monitored at these time points for antibodies against PERV s. Results Beginning in 2009, fourteen patients with severe unaware hypoglycemia were treated with one of four different dosages of alginate‐encapsulated porcine islets ranging from 5000–20 000 islet equivalents delivered in a single dose. No transmission of either PERV s or other porcine microorganisms was detected by PCR and immunological methods. Conclusion These findings support previous results and strongly indicate the safety of xenotransplantation as performed here. Article in Journal/Newspaper Auckland Island Wiley Online Library New Zealand Xenotransplantation 21 4 309 323 |
institution |
Open Polar |
collection |
Wiley Online Library |
op_collection_id |
crwiley |
language |
English |
description |
Abstract Background Xenotransplantation using pig cells, tissues, or organs may be associated with the transmission of porcine microorganisms and the development of zoonoses. Among all porcine microorganisms porcine endogenous retroviruses ( PERV s) represent a special risk because they are integrated in the genome of all pigs and able to infect human cells. In previous preclinical and retrospective clinical trials of xenotransplantation, no transmission of PERV was observed. The first clinical trial of (alginate‐encapsulated) porcine islet cell transplantation in New Zealand, which was approved by the New Zealand Government as an open‐label phase I/ II a safety/efficacy trial, offers the possibility to analyze microbiological safety in a prospective clinical study. Methods Before the trial started, a multilevel testing strategy was used to screen for 26 microorganisms in donor pigs of the Auckland Island strain and the islet cell preparations used for treatment. Donor testing was performed using molecular methods including multiplex real‐time PCR . Blood samples from 14 pig islet cell recipients were also investigated by molecular biological methods at weeks 1, 4, 8, 12, 24, and 52 post‐transplant for the transmission of porcine microorganisms. Sera were also monitored at these time points for antibodies against PERV s. Results Beginning in 2009, fourteen patients with severe unaware hypoglycemia were treated with one of four different dosages of alginate‐encapsulated porcine islets ranging from 5000–20 000 islet equivalents delivered in a single dose. No transmission of either PERV s or other porcine microorganisms was detected by PCR and immunological methods. Conclusion These findings support previous results and strongly indicate the safety of xenotransplantation as performed here. |
format |
Article in Journal/Newspaper |
author |
Wynyard, Shaun Nathu, Divya Garkavenko, Olga Denner, Joachim Elliott, Robert |
spellingShingle |
Wynyard, Shaun Nathu, Divya Garkavenko, Olga Denner, Joachim Elliott, Robert Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand |
author_facet |
Wynyard, Shaun Nathu, Divya Garkavenko, Olga Denner, Joachim Elliott, Robert |
author_sort |
Wynyard, Shaun |
title |
Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand |
title_short |
Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand |
title_full |
Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand |
title_fullStr |
Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand |
title_full_unstemmed |
Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand |
title_sort |
microbiological safety of the first clinical pig islet xenotransplantation trial in new zealand |
publisher |
Wiley |
publishDate |
2014 |
url |
http://dx.doi.org/10.1111/xen.12102 https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fxen.12102 https://onlinelibrary.wiley.com/doi/pdf/10.1111/xen.12102 |
geographic |
New Zealand |
geographic_facet |
New Zealand |
genre |
Auckland Island |
genre_facet |
Auckland Island |
op_source |
Xenotransplantation volume 21, issue 4, page 309-323 ISSN 0908-665X 1399-3089 |
op_rights |
http://onlinelibrary.wiley.com/termsAndConditions#vor |
op_doi |
https://doi.org/10.1111/xen.12102 |
container_title |
Xenotransplantation |
container_volume |
21 |
container_issue |
4 |
container_start_page |
309 |
op_container_end_page |
323 |
_version_ |
1802642548131364864 |