Ethical and regulatory guidelines in clinical trials of xenocorneal transplantation in Korea; The Korean xenocorneal transplantation consensus statement

Mee Kum Kim, Jong Joo Lee, Hyuk Jin Choi, Ivo Kwon, Hyungkeun Lee, Jong Suk Song, Myoung Joon Kim, Eui Sang Chung, Won Ryang Wee, Chung Gyu Park, Sang Joon Kim

Research output: Contribution to journalReview articlepeer-review

12 Citations (Scopus)

Abstract

Background To establish the consensus about the conditions for undertaking clinical trials in xenocorneal transplantation in Korea, specific issues regarding the xenocorneal transplantation on ethical and regulatory aspects are addressed, and the guidelines to conduct clinical trial of the xenocorneal transplantation are proposed. Method and Results Chapter 1 reviews the key ethical requirements and progress of a Korean regulatory framework for clinical trials of xenocorneal transplantation. Chapters 2-7 provide recommendations on source pigs, quality control of porcine corneal procurement, preclinical efficacy required to justify a clinical trial, strategies to prevent transmission of porcine endogenous retrovirus (PERV), patient selection for clinical trials, and informed consent in xenocorneal transplantation using either cellularized or decellularized porcine graft, which are essentially based on the International Xenotransplantation Association (IXA) islet xenotransplantation consensus statement. The consensus statement of the inclusion criteria for the patients' selection has been made by the executive board members in Korean External Eye Disease Society. Conclusions This consensus statement will be a good initiative for Korean Food and Drug Administration to discuss final regulatory guidelines in conducting clinical trials of xenocorneal transplantation in Korea and for International Xenotransplantation Association to develop International Consensus Standards of Xenocorneal Transplantation.

Original languageEnglish
Pages (from-to)209-218
Number of pages10
JournalXenotransplantation
Volume20
Issue number4
DOIs
Publication statusPublished - 2013 Jul

Keywords

  • consensus statement
  • cornea
  • ethics
  • guideline
  • regulation
  • xenocorneal transplantation
  • xenotransplantation

ASJC Scopus subject areas

  • Immunology
  • Transplantation

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