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News From the Food and Drug Administration
August 14, 2002

Xenotransplantation Advisory

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JAMA. 2002;288(6):688. doi:10.1001/jama.288.6.688

The FDA wishes to remind physicians and clinical investigators that its definition of xenotransplantation includes any procedure that involves the transplantation, implantation, or infusion into a human recipient of human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs. The definition includes human embryos co-cultured with living nonhuman animal cellular material, such as bovine tubal cells or Vero cells, and includes feeder layer cells irradiated to render them nonproliferative.