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The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation
Author(s) -
Kim Mee Kum,
Choi Hyuk Jin,
Kwon Ivo,
Pierson Richard N.,
Cooper David K. C.,
Soulillou JeanPaul,
O'Connell Philip J.,
Vabres Bertrand,
Maeda Naoyuki,
Hara Hidetaka,
Scobie Linda,
Gianello Pierre,
Takeuchi Yasuhiro,
Yamada Kazuhiko,
Hwang EungSoo,
Kim Sang Joon,
Park ChungGyu
Publication year - 2014
Publication title -
xenotransplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.052
H-Index - 61
eISSN - 1399-3089
pISSN - 0908-665X
DOI - 10.1111/xen.12129
Subject(s) - xenotransplantation , transplantation , statement (logic) , medicine , clinical trial , association (psychology) , intensive care medicine , psychology , political science , law , psychotherapist
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.