He's All Heart... and a Little Pig Too: A Look at the FDA Draft Xenotransplant Guideline

摘要

The recent transplant of baboon bone marrow into an AIDS patient, Jeff Getty, has received much attention in the popular press and thrust the potential of xenotransplantation into the realm of medical possibility. In the wake of the Getty transplant,the Food and Drug Administration (FDA) collaborated with the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA) in the development and publication for comment of its Draft Guideline on Infectious Disease Issues in Xenotransplantation. This draft guideline would require an investigational new drug (IIMD) application prior to proceeding with a xenotransplant, set forth parameters for a xenotransplantation protocol, define animal sources, and address clinical issues, as well as other public health considerations.