PHS releases final xenotransplant guideline

The U.S. Public Health Service on Monday issued a final guideline on infectious disease issues in xenotransplantation. The definition of xenotransplantation has been modified from the draft guideline to include "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." In addition, xenotransplantation products have been defined to include live cells, tissues or organs used in xenotransplantation. The final guideline states that although a number of institutions, such as institutional review boards, are responsible for reviewing aspects of xenotransplantation clinical trials conducted in the U.S., FDA has regulatory oversight of such trials. In a change from the draft guideline, primary responsibility for designing and monitoring the conduct of xenotransplantation clinical trials has been shifted to the sponsor from clinical centers, source animal facilities, and individual investigators. ...