Regulatory issues in xenotransplantation: recent developments.
OBJECTIVE
This article reviews recent literature on regulatory issues of xenotransplantation, focusing primarily on current progress with transplantation of pancreatic islets for diabetic patients. The need for a global system that connects the national and international regulatory levels within a coherent framework is emphasized.


RESULTS
Recent progress in preclinical xenotransplantation of pancreatic islets has enhanced the hopes of providing patients with safe and effective treatments from animal cells and tissues in the near future. At the same time the increasing number of clinical trials proposed and sometimes authorized calls for attention from regulatory authorities.


CONCLUSIONS
Although the main regulatory aspects of xenotransplantation have been identified since the early 1990s, regulatory problems connected to the promising scientific data published in the field of pancreatic islets still require attention. In fact most normative issues, such as criteria for patients' enrollment in clinical trials and the management of safety measures have been primarily explored in relation to solid organ transplantation. Also the issue of animal rights has become more compelling in relation to the treatment of nonhuman primates in preclinical trials. In these rapidly evolving conditions the establishment of agreed guidelines at both the national and international levels remains the most urgent goal to be achieved.
Tallacchini
Mariachiara
M
Facoltà di Giurisprudenza, Università Cattolica S.C., Piacenza, Italy. mariachiara.tallacchini@unimi.it
Beloucif
Sadek
S
D017087:Animal Rights / Q000331:legislation & jurisprudence; D000818:Animals; D017690:Cell Transplantation / Q000009:adverse effects / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery*; D005062:European Union; D033161:Government Regulation; D006291:Health Policy; D006801:Humans; D007391:International Cooperation; D016381:Islets of Langerhans Transplantation / Q000009:adverse effects / Q000331:legislation & jurisprudence*; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D011323:Primates; D018570:Risk Assessment; D014183:Transplantation, Heterologous; D014481:United States; D014944:World Health Organization