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

Title
Ethical and regulatory guidelines in clinical trials of xenocorneal transplantation in Korea; The Korean xenocorneal transplantation consensus statement
Authors
Kim M.K.Lee J.J.Choi H.J.Kwon I.Lee H.Song J.-S.Kim M.J.Chung E.-S.Wee W.R.Park C.-G.Kim S.J.
Ewha Authors
권복규
SCOPUS Author ID
권복규scopus
Issue Date
2013
Journal Title
Xenotransplantation
ISSN
0908-665XJCR Link
Citation
vol. 20, no. 4, pp. 209 - 218
Indexed
SCI; SCIE; SCOPUS WOS 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. © 2013 John Wiley & Sons A/S.
DOI
10.1111/xen.12036
Appears in Collections:
의학전문대학원 > 의학과 > Journal papers
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