title: Some ethical, social, and legal considerations of xenotransplantation.
abstract: Xenotransplantation has changed its focus from solid organs to cells and tissues, and it is now mainly conceived of and regulated as a pharmaceutical product. Animal cell therapies are showing promising results and may involve fewer risks than organs. However, countries should be cautious about allowing xenotransplantation clinical trials to develop. Regulatory frameworks should contain specific conditions about the safety of the source animals, of the xenotransplantation product, and of the manufacturing process. In turn, these frameworks should ensure that preclinical studies indicate safety and efficacy of the procedure and that risk-management protocols are in place to identify, contain, and combat any outbreak of infection in a timely manner. The fragile balance between individual and collective rights and the tensions of globalization make necessary a coordinated international action to harmonize global practices in this field. Xenotransplantation clinical trials should be carried out in a context in which specific safety and ethical issues are addressed, and in an environment in which specific practices that facilitate public engagement as a form of shared responsibility for regulatory decision making are promoted as well.
authors.affiliation: University of Deusto, Bilbao, Spain. maria.jorqui@deusto.es
authors.forename: María Jorqui
authors.initials: MJ
authors.lastname: Azofra
authors.forename: Carlos María Romeo
authors.initials: CM
authors.lastname: Casabona
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D014183:Transplantation, Heterologous / Q000941:ethics* / Q000331:legislation & jurisprudence*