Xenotransplant safety

Xenotransplant safety Although the FDA has effectively put a hold on clinical trials involving non-human primate xenotransplantation, the move isn't likely to have a direct impact on most xenotransplant companies, which are focused on pigs as a source of tissue. But the FDA's stance may establish an uncertain regulatory climate until the agency reveals more of its thinking.

The agency has issued a guidance recommending that "clinical protocols proposing the use of nonhuman primate xenografts should not be submitted to the FDA until sufficient scientific information exists addressing the risks posed by nonhuman primate xenotransplants," primarily including the risk of transmitting infectious diseases such as simian immunodeficiency virus (SIV), simian T-lymphotropic viruses (STLV) and herpes viruses...