Scientific Publications by FDA Staff

Xenotransplantation 2007 Jul;14(4):309-15

No evidence of PERV infection in healthcare workers exposed to transgenic porcine liver extracorporeal support.

Levy MF, Argaw T, Wilson CA, Brooks J, Sandstrom P, Merks H, Logan J, Klintmalm G

Levy MF (reprint author), Baylor All St Med Ctr, 1400 8th Ave, Ft Worth, TX 76104 USA Baylor All St Med Ctr, Ft Worth, TX 76104 USA US FDA, CBER, Div Cellular & Gene Therapies, Bethesda, MD 20014 USA Publ Hlth Agcy Canada, Ctr Infect Dis Prevent & Control, Natl HIV & Retrovirol Labs, Ottawa, ON Canada Baxter Healthcare Corp, McGaw Pk, IL USA Baylor Univ, Med Ctr, Dallas, TX USA

Background: Clinical xenotransplantation holds great promise by providing one solution to the shortage of human organs for transplantation, while also posing a potential public health threat by facilitating transmission of infectious disease from source animals to humans. One potential vector for infectious disease transmission is healthcare workers (HCW) who are involved in administering xenotransplantation procedures. Methods: In this study, we studied 49 healthcare workers involved in the care of two subjects who participated in a study of porcine liver perfusion as treatment of fulminant hepatic failure. We looked for serologic and virologic evidence of transmission of porcine endogenous retrovirus, and found that HCW had no evidence of infection. Conclusions: Results of our survey demonstrate that application of standard precautions may be sufficient to prevent transmission of porcine endogenous retrovirus, an agent of concern in ex vivo xenotransplantation products.