Xenotransplantation

Xenotransplantation is the transplantation of living cells, tissues or organs from one species to another. Xenotransplantation is also being used in the effort to treat diseases for which human organ allotransplants are not traditional therapies (e.g., epilepsy, chronic intractable pain syndromes, insulin dependent diabetes mellitus and degenerative neurologic diseases such as Parkinson’s disease and Huntington’s disease).[1]

The Food and Drug Administration (FDA) regulates xenotransplantation. The FDA has approved limited clinical trials with animal tissues, cells, and organs, typically pig livers, used outside the body as temporary “bridges” to “filter” the blood of patients awaiting human liver transplants. Xenotransplantation products that utilize both a device and a biologic (such as the “liver-assist device”) would be considered a combination product and regulated both the FDA’s Center for Biologic Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Animal organs used in xenotransplantation would be considered biologics covered by CBER.[2]

Interest in animal-to-human xenotransplantation has been spurred by the continuing shortage of donated human organs and by advances in knowledge concerning the biology of organ and tissue rejection. The scientific advances and promise, however, raise complex questions that are yet to be addressed.

FDA Resources:

Updated by Peter Matos, December 2023