Regulation of Clinical Xenotransplantation: A Reappraisal of the Legal, Ethical, and Social Aspects Involved.

Clinical trials of encapsulated pig islet transplantation are underway and are showing promising results. In addition, better immunosuppressant drug regimens and a wealth of new gene-edited pig varieties are raising new hopes in this field. Thus, consideration is also being given to the selection of patients for initial clinical trials of pig solid organ xenotransplantation. It seems likely that clinical trials of pig organ will be initiated within the next couple of years. For the moment, transplanting porcine islets to treat type 1 diabetes is generally viewed as the most likely to reach the clinical first. Further advances will hopefully make this approach a treatment choice for patients with this condition. Regulatory framework for this type of xenotransplantation is now available in several countries, and there is also a wider awareness of the importance of developing an internationally harmonized regulatory framework. For now, xenotransplantation is mainly conceived and regulated as a pharmaceutical product. The reframing of this emerging technology as cell therapy has redefined the normative landscape. Countries should be cautious about allowing xenotransplantation clinical trials to develop. But the original meaning of precaution, referred to safety measures in order to control risks of infection, is no longer seen as requiring restrictive limitations on fundamental rights. As with any new medicinal product, safety is certainly a crucial topic in research. Specific to xenotransplantation is the safety of porcine product. In this regard, 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.