by Carolyn A. Wilson, PhD, Eda T. Bloom, PhD, Louisa E. Chapman, MD, and Clive Patience, PhD
Volume 2, Issue 2 (March/April 2003)
Xenotransplantation has been defined by the US Public Health Service (PHS) as any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live, nonhuman animal cells, tissues, or organs (PHS Guideline on Infectious Disease Issues in Xenotransplantation). In the US, several xenotransplantation clinical trials are in progress under US Food and Drug Administration (FDA) oversight. The PHS and the FDA have issued guidelines and guidance documents to address the potential for cross-species infection posed by the use of xenotransplantation products in humans. To minimize the infectious disease risk, these documents provide recommendations on how to screen and maintain source herds, individual source animals, and when possible, xenotransplantation products themselves. However, while precautions can be put in place to remove exogenous infectious agents, the endogenous retroviruses that a source species may carry cannot be removed…
Citation:
Wilson CA, Bloom ET, Chapman LE, Patience C. Reagents for Assessing Seroreactivity Against Porcine Endogenous Retrovirus: Summary from Public Meeting and Workshop. BioProcess J, 2003; 2(2): 27-30. https://doi.org/10.12665/J22.Wilson.