Reply to ‘Clarifying US regulations on xenotransplantation’ and ‘International standards and guidelines for xenotransplantation’

Xenotransplantation literature update March 2023–November 2023

“…7 Similar dialogues within the xenotransplantation community were centered around the actual feasibility of clinical trials, with a significant focus on addressing ethical and legal considerations. 8,9 Recent discussions, such as those in Germany and China, [10][11][12] have underscored the need to navigate past preclinical applications and achieve regulatory acceptance. A key focal point in these discussions pertains to fair and equitable patient selection and participation in clinical trials.…”

Unaddressed regulatory issues in xenotransplantation: a hypothetical example

“…It is clear that numerous regulatory concerns need to be addressed before such an approach can be translated into routine practice. In our previous work, we described three key issues pertaining to the creation of human-pig chimeras/multitransgenic pigs, namely: (1) the potential uncertainty as to which framework captures humananimal chimeras or multitransgenic pigs; (2) what the end product is and by which regulation it is captured; and (3) who the owner of the xenoproduct is (13,14). While we previously discussed these in terms of hindrances to prospective supranational or international regulatory frameworks, we will now play out the scenario in a concrete jurisdiction by describing the necessary steps to be undertaken in order for a patient to receive a chimeric organ for two reasons.…”