Governance, regulation and public trust in xenotransplantation

Across the world, several solid organ xenotransplants have been reported as being provided to deceased people and to living patients. In the United States, xenotransplants to living patients have been authorized under the Food and Drug Administration's Expanded Access program, and clinical liver and kidney xenotransplants have also been reported in China. During 2025, the first clinical trials of kidney and liver xenotransplants have been approved in the United States. These developments make it necessary to understand the regulatory and governance issues and challenges raised by clinical xenotransplants.

Key regulatory and governance issues remain to be addressed before xenotransplant clinical trials begin, including identifying the responsible regulator, drafting informed consent protocols, and establishing long-term monitoring regimens. International cooperation and collaboration are key to establishing appropriate and effective regulatory regimes and frameworks which enable science to proceed while offering the necessary protections to those involved. Public awareness, education and trust are central to the success of clinical xenotransplantation.

Starting xenotransplant clinical trials too soon and without appropriate regulation and governance, may affect public trust in this biotechnology specifically and science more generally. The possible risks of xenotransplantation necessitate exploration of global harmonization and regulatory frameworks for clinical xenotransplantation.