Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea.
Xenotransplantation. 2013 Jul-Aug;20(4):209-18. doi: 10.1111/xen.12036. Epub 2013 May 20.
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.
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.
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.
为了在韩国建立关于进行异种角膜移植临床试验的共识，针对异种角膜移植的伦理和监管方面的具体问题进行了探讨，并提出了进行异种角膜移植临床试验的指南。
第 1 章回顾了韩国异种角膜移植临床试验的关键伦理要求和监管框架的进展。第 2-7 章就供体猪的来源、猪角膜采集的质量控制、 justifies a clinical trial 的临床前功效、预防猪内源性逆转录病毒（PERV）传播的策略、临床实验中的患者选择以及使用细胞化或去细胞化猪移植物进行异种角膜移植的知情同意等方面提供了建议，这些建议主要基于国际异种移植协会（IXA）胰岛异种移植共识声明。患者选择的纳入标准共识声明由韩国眼外疾病学会的执行委员会成员制定。
本共识声明将是韩国食品药品监督管理局讨论在韩国进行异种角膜移植临床试验的最终监管指南的良好举措，也是国际异种移植协会制定异种角膜移植国际共识标准的良好举措。
