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Non‐viral pathogens: Identification, relevance, and prevention for xenotransplantation
Author(s) -
Tönjes Ralf R.
Publication year - 2018
Publication title -
xenotransplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.052
H-Index - 61
eISSN - 1399-3089
pISSN - 0908-665X
DOI - 10.1111/xen.12413
Subject(s) - xenotransplantation , medicine , intensive care medicine , food and drug administration , human health , infectious disease (medical specialty) , microbiology and biotechnology , disease , virology , transplantation , environmental health , biology , pathology , surgery
Background For xenotransplantation, strategies to prevent transmission of microorganisms from the source animal to the human recipient must be closely coordinated since tissues and organs are classified as non‐sterile. Strategies for international cooperation and coordination of xenogeneic infection / disease surveillance and response are available. Methods The regulatory frameworks and criteria on microbial safety as published by World Health Organization ( WHO ), European Pharmacopoeia (Ph. Eur.), European Medicines Agency ( EMA ) as well as U.S. Department of Health and Human Services ( DHHS ), Food and Drug Administration ( FDA ) and Center for Biologics Evaluation and Research ( CBER ), are outlined. Results Different sources of microbial germs are considered including potential infectious agents. Monitoring of livestock and testing of xenografts is accompanied by positive and negative controls to detect and to exclude tissue specific microorganisms such as bacteria. Conclusions The criteria of microbial status to be considered for xenotransplants are summarized.