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Among all porcine microorganisms porcine endogenous retroviruses (<jats:styled-content style=\"fixed-case\">PERV<\/jats:styled-content>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 <jats:styled-content style=\"fixed-case\">PERV<\/jats:styled-content> was observed. The first clinical trial of (alginate\u2010encapsulated) porcine islet cell transplantation in New Zealand, which was approved by the New Zealand Government as an open\u2010label phase I\/<jats:styled-content style=\"fixed-case\">II<\/jats:styled-content>a safety\/efficacy trial, offers the possibility to analyze microbiological safety in a prospective clinical study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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\u2010time <jats:styled-content style=\"fixed-case\">PCR<\/jats:styled-content>. 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\u2010transplant for the transmission of porcine microorganisms. Sera were also monitored at these time points for antibodies against <jats:styled-content style=\"fixed-case\">PERV<\/jats:styled-content>s.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Beginning in 2009, fourteen patients with severe unaware hypoglycemia were treated with one of four different dosages of alginate\u2010encapsulated porcine islets ranging from 5000\u201320\u00a0000 islet equivalents delivered in a single dose. No transmission of either <jats:styled-content style=\"fixed-case\">PERV<\/jats:styled-content>s or other porcine microorganisms was detected by <jats:styled-content style=\"fixed-case\">PCR<\/jats:styled-content> and immunological methods.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These findings support previous results and strongly indicate the safety of xenotransplantation as performed here.<\/jats:p><\/jats:sec>","DOI":"10.1111\/xen.12102","type":"journal-article","created":{"date-parts":[[2014,5,7]],"date-time":"2014-05-07T07:20:13Z","timestamp":1399447213000},"page":"309-323","source":"Crossref","is-referenced-by-count":211,"title":["Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand"],"prefix":"10.1111","volume":"21","author":[{"given":"Shaun","family":"Wynyard","sequence":"first","affiliation":[{"name":"Living Cell Technologies Manukau New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Divya","family":"Nathu","sequence":"additional","affiliation":[{"name":"Living Cell Technologies Manukau New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Garkavenko","sequence":"additional","affiliation":[{"name":"Living Cell Technologies Manukau New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Denner","sequence":"additional","affiliation":[{"name":"Robert Koch Institute Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Elliott","sequence":"additional","affiliation":[{"name":"Living Cell Technologies Manukau New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,5,7]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)61091-X"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-0012.2011.01471.x"},{"key":"e_1_2_8_4_1","unstructured":"United Health Group.2010.The United States of Diabetes: Challenges and Opportunities in the Decade Ahead. 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