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Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand

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 (PERVs) 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/IIa safety/efficacy trial, offers the possibility to analyze microbiological safety in a prospective clinical study.