title: First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 1: update on national regulatory frameworks pertinent to clinical islet xenotransplantation.
abstract: Islet xenotransplantation represents an attractive solution to overcome the shortage of human islets for use in type 1 diabetes. The wide-scale application of clinical islet xenotransplantation, however, requires that such a procedure takes place in a specifically and tightly regulated environment. With a view to promoting the safe application of clinical islet xenotransplantation, a few years ago the International Xenotransplantation Association (IXA) published a Consensus Statement that outlined the key ethical and regulatory requirements to be satisfied before the initiation of xenotransplantation studies in diabetic patients. This earlier IXA Statement also documented a disparate regulatory landscape among different geographical areas. This situation clearly fell short of the 2004 World Health Assembly Resolution WHA57.18 that urged Member States "to cooperate in the formulation of recommendations and guidelines to harmonize global practices" to ensure the highest ethical and regulatory standards on a global scale. In this new IXA report, IXA members who are active in xenotransplantation research in their respective geographic areas herewith briefly describe changes in the regulatory frameworks that have taken place in the intervening period in the various geographic areas or countries. The key reassuring take-home message of the present report is that many countries have embraced the encouragement of the WHO to harmonize the procedures in a more global scale. Indeed, important regulatory changes have taken place or are in progress in several geographic areas that include Europe, Korea, Japan, and China. Such significant regulatory changes encompass the most diverse facets of the clinical application of xenotransplantation and comprise ethical aspects, source animals and product specifications, study supervision, sample archiving, patient follow-up and even insurance coverage in some legislations. All these measures are expected to provide a better care and protection of recipients of xenotransplants but also a higher safety profile to xenotransplantation procedures with an ultimate net gain in terms of international public health.
authors.affiliation: Department of Transfusion Medicine, Transplant Immunology Unit, Padua University Hospital, Padua, Italy.|CORIT (Consortium for Research in Organ Transplantation), Padua, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Cozzi
authors.affiliation: Division of Medical Biotechnology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
authors.forename: Ralf R
authors.initials: RR
authors.lastname: Tönjes
authors.affiliation: Department of Health Sciences, Institute for Experimental and Clinical, Experimental Surgery and Transplantation, Catholic University of Louvain, Brussels, Belgium.
authors.forename: Pierre
authors.initials: P
authors.lastname: Gianello
authors.affiliation: Department of Visceral Surgery, Hôpitaux Universitaires de Genève, Genève, Switzerland.
authors.forename: Léo H
authors.initials: LH
authors.lastname: Bühler
authors.affiliation: Faculty of Medicine and Dentistry, Department of Surgery, The Surgical-Medical Research Institute and Alberta Diabetes Institute, University of Alberta, Edmonton, Canada.
authors.forename: Gina R
authors.initials: GR
authors.lastname: Rayat
authors.affiliation: Otsuka Pharmaceutical Factory, Inc., Tokushima, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Matsumoto
authors.affiliation: Department of Microbiology and Immunology, Xenotransplantation Research Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Chung-Gyu
authors.initials: CG
authors.lastname: Park
authors.affiliation: Department of Microbiology and Immunology, Xenotransplantation Research Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Ivo
authors.initials: I
authors.lastname: Kwon
authors.affiliation: Institute for Cell Transplantation and Gene Therapy, NHFPC Engineering Center for Transplantation Medicine, The 3rd Xiangya Hospital of Central South University, Changsha, People Republic of China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Transplantation Unit, University of Sydney at Westmead Hospital, Westmead, Australia.
authors.forename: Philip
authors.initials: P
authors.lastname: O'Connell
authors.affiliation: Medsafe Clinical Leadership Protection & Regulation Ministry of Health, Wellington; New Zealand.
authors.forename: Stewart
authors.initials: S
authors.lastname: Jessamine
authors.affiliation: Diatranz Otsuka Ltd, Manukau, Auckland, New Zealand.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Elliott
authors.affiliation: Department of Renal Transplant Surgery, Aichi Medical University School of Medicine, Nagakute, JAPAN.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Schulze Diabetes Institute, University of Minnesota, Minneapolis, USA.
authors.forename: Bernhard J
authors.initials: BJ
authors.lastname: Hering
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery*; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D016381:Islets of Langerhans Transplantation / Q000379:methods; D018579:Patient Selection / Q000941:ethics*; D013552:Swine; D014183:Transplantation, Heterologous / Q000331:legislation & jurisprudence* / Q000379:methods
keywords: national regulatory frameworks; type 1 diabetes; xenotransplantation