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

Emanuele Cozzi, Ralf R. Tönjes, Pierre Gianello, Léo H. Bühler, Gina R. Rayat, Shinichi Matsumoto, Chung Gyu Park, Ivo Kwon, Wei Wang, Philip O'Connell, Stewart Jessamine, Robert B. Elliott, Takaaki Kobayashi, Bernhard J. Hering

Research output: Contribution to journalReview article

11 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)14-24
Number of pages11
JournalXenotransplantation
Volume23
Issue number1
DOIs
StatePublished - 1 Jan 2016

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Heterologous Transplantation
Type 1 Diabetes Mellitus
Swine
Clinical Trials
Insurance Coverage
Korea
Legislation
China
Japan
Public Health
Guidelines

Keywords

  • national regulatory frameworks
  • type 1 diabetes
  • xenotransplantation

Cite this

Cozzi, Emanuele ; Tönjes, Ralf R. ; Gianello, Pierre ; Bühler, Léo H. ; Rayat, Gina R. ; Matsumoto, Shinichi ; Park, Chung Gyu ; Kwon, Ivo ; Wang, Wei ; O'Connell, Philip ; Jessamine, Stewart ; Elliott, Robert B. ; Kobayashi, Takaaki ; Hering, Bernhard J. / 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. In: Xenotransplantation. 2016 ; Vol. 23, No. 1. pp. 14-24.
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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. / Cozzi, Emanuele; Tönjes, Ralf R.; Gianello, Pierre; Bühler, Léo H.; Rayat, Gina R.; Matsumoto, Shinichi; Park, Chung Gyu; Kwon, Ivo; Wang, Wei; O'Connell, Philip; Jessamine, Stewart; Elliott, Robert B.; Kobayashi, Takaaki; Hering, Bernhard J.

In: Xenotransplantation, Vol. 23, No. 1, 01.01.2016, p. 14-24.

Research output: Contribution to journalReview article

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