Keywords

History and Current Status

Currently, the National Health Commission of the People’s Republic of China regard organ xenotransplantation technology as medical technology of Class III—a high tier category that includes medical technologies with major ethical issues as well as safety and effectiveness concerns [1]. The 2008 and 2018 Changsha Communiqué stimulated the efforts in China in the following areas: (a) xenozoonosis; (b) regulatory; (c) biorepository; (d) transgenic pig facilities; (e) biomaterials and encapsulation; and (f) immunosuppression and tolerance induction [2, 3]. Also, the General Offices of the CPC Central Committee and the State Council released a set of guidelines to Strengthen the Governance over Ethics in Science and Technology on March 20, 2022 [4]. These guidelines clarified the principles and requirements of science and technology including xenotransplantation ethics principles and governance requirements, governance system and governance system guarantee. According to the guidelines, it is important that scientific activities serve humanity, respect people’s rights to life, adhere to fairness and justice, control risks appropriately, and maintain openness and transparency. All the above efforts reflect the state of xenotransplant science and support in China.

There are three guidelines and expert consensuses related to xenotransplantation. Firstly, the Chinese Medical Association of Organ transplantation Xenotransplantation group released the Clinical Research Guidelines on xenotransplantation on Nov 15, 2018 (2018 Expert Recommendations, see Table 12.1) [5]. Secondly, the above association released the Clinical Trial Expert Consensus on islet xenotransplantation on Nov 15, 2019 (2019 Expert Recommendations, see Table 12.2) [6]. The quality standards and ethical requirements of islet xenotransplantation are stipulated, which facilitate the development of clinical islet xenotransplantation technology. Thirdly, the China Organ Transplantation Development Foundation released the “Expert Consensus on Clinical Trials of Human Xenotransplantation in China” on April 6, 2022 [7]. The “Consensus” states that xenotransplantation is essential and that its academic findings can contribute in the advancement of the transplantation field. The “Consensus” stated that the technological preparations, ethics, and development of regulations are still lacking compared with globally advanced levels.

Table 12.1 Key points of the Clinical Research Guidance on xenotransplantation (2018 Expert Recommendations) [2]
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Table 12.2 Key points of the expert consensus in clinical research on islet xenotransplantation (2019 Expert Recommendations) [3]
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The above guidelines came as a result of advanced allotransplantation efforts in China. Especially, most of the experts who release the guidelines are from the allotransplantation field. The guidelines were prepared by a subcommittee of experts from regulatory, clinical, and scientific research specializations. The guidelines will guide the further development and standardization of clinical research on xenotransplantation.