Abstract:
Subclinical research of xenotransplantation involves xenotransplantation trial using brain death donors, which is an important intermediate step from basic research and animal experiments to the clinical application of xenotransplantation. It provides necessary data support for the safety and efficacy of xenotransplantation. In order to promote the safe, orderly, scientific and standardized development of subclinical research on xenotransplantation, the Xenotransplantation Group of Branch of Organ Transplantation of Chinese Medical Association formulated the “Expert Consensus on Subclinical Research of Xenotransplantation (2024 Edition)” based on relevant laws and regulations. The consensus includes aspects such as the selection of donor pigs, recipient selection criteria, legal and ethical requirements, determination of trial termination time, family informed consent system, and brain death determination standards.