| 김미금1,2,3,10, 이종주1,2,3, 최혁진1,2,3, 권복규3,4, 이형근5,10, 송종석6,10, 김명준7,10, 정의상8, 10, 위원량1,2,3, 박정규3,9, 김상준3 |
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목적 : 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.
방법 : Chapter 1 reviews the key ethical requirements and progress of a Korean regulatory framework for clinical trials of xenocorneal transplantation. Chapters 2 to 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, patient selection for clinical trials, and informed consent in xenocorneal transplantation using either cellularized or decellularized porcine graft
결과 : 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. The consensus statement of the xeno-related regulation has been made by the members of xenotransplantation research center in Korea.
결론 : 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 (IXA) to develop international consensus standards of xenocorneal transplantation.
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