The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation

Mee Kum Kim, Hyuk Jin Choi, Ivo Kwon, Richard N. Pierson, David K.C. Cooper, Jean Paul Soulillou, Philip J. O'Connell, Bertrand Vabres, Naoyuki Maeda, Hidetaka Hara, Linda Scobie, Pierre Gianello, Yasuhiro Takeuchi, Kazuhiko Yamada, Eung Soo Hwang, Sang Joon Kim, Chung Gyu Park

Research output: Contribution to journalReview articlepeer-review

28 Scopus citations

Abstract

To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation, here we review specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and propose guidelines for conduct of clinical xenocorneal transplantation trials. These proposed guidelines are modeled on the published consensus statement of the International Xenotransplantation Association regarding recommended guidelines for conduct of clinical islet xenotransplantation. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.

Original languageEnglish
Pages (from-to)420-430
Number of pages11
JournalXenotransplantation
Volume21
Issue number5
DOIs
StatePublished - 1 Sep 2014

Bibliographical note

Publisher Copyright:
© 2014 John Wiley & Sons A/S Published by John Wiley & Sons Ltd.

Keywords

  • consensus statement
  • cornea
  • ethics
  • international Guideline
  • regulation
  • xenocorneal transplantation
  • xenotransplantation

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