The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation

Mee Kum Kim; Hyuk Jin Choi; Ivo Kwon; Richard N. Pierson; David K.C. Cooper; Jean Paul Soulillou; Philip J. O'Connell; Bertrand Vabres; Naoyuki Maeda; Hidetaka Hara; Linda Scobie; Pierre Gianello; Yasuhiro Takeuchi; Kazuhiko Yamada; Eung Soo Hwang; Sang Joon Kim; Chung Gyu Park

doi:10.1111/xen.12129

The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation

Mee Kum Kim, Hyuk Jin Choi, Ivo Kwon, Richard N. Pierson, David K.C. Cooper, Jean Paul Soulillou, Philip J. O'Connell, Bertrand Vabres, Naoyuki Maeda, Hidetaka Hara, Linda Scobie, Pierre Gianello, Yasuhiro Takeuchi, Kazuhiko Yamada, Eung Soo Hwang, Sang Joon Kim, Chung Gyu Park

Department of Medical Education

Research output: Contribution to journal › Review article › peer-review

30 Scopus citations

Abstract

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.

Original language	English
Pages (from-to)	420-430
Number of pages	11
Journal	Xenotransplantation
Volume	21
Issue number	5
DOIs	https://doi.org/10.1111/xen.12129
State	Published - 1 Sep 2014

Bibliographical note

Publisher Copyright:
© 2014 John Wiley & Sons A/S Published by John Wiley & Sons Ltd.

Keywords

consensus statement
cornea
ethics
international Guideline
regulation
xenocorneal transplantation
xenotransplantation

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10.1111/xen.12129

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Kim, M. K., Choi, H. J., Kwon, I., Pierson, R. N., Cooper, D. K. C., Soulillou, J. P., O'Connell, P. J., Vabres, B., Maeda, N., Hara, H., Scobie, L., Gianello, P., Takeuchi, Y., Yamada, K., Hwang, E. S., Kim, S. J., & Park, C. G. (2014). The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation. Xenotransplantation, 21(5), 420-430. https://doi.org/10.1111/xen.12129

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title = "The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation",

abstract = "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.",

keywords = "consensus statement, cornea, ethics, international Guideline, regulation, xenocorneal transplantation, xenotransplantation",

author = "Kim, {Mee Kum} and Choi, {Hyuk Jin} and Ivo Kwon and Pierson, {Richard N.} and Cooper, {David K.C.} and Soulillou, {Jean Paul} and O'Connell, {Philip J.} and Bertrand Vabres and Naoyuki Maeda and Hidetaka Hara and Linda Scobie and Pierre Gianello and Yasuhiro Takeuchi and Kazuhiko Yamada and Hwang, {Eung Soo} and Kim, {Sang Joon} and Park, {Chung Gyu}",

note = "Publisher Copyright: {\textcopyright} 2014 John Wiley & Sons A/S Published by John Wiley & Sons Ltd.",

year = "2014",

month = sep,

day = "1",

doi = "10.1111/xen.12129",

language = "English",

volume = "21",

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journal = "Xenotransplantation",

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Kim, MK, Choi, HJ, Kwon, I, Pierson, RN, Cooper, DKC, Soulillou, JP, O'Connell, PJ, Vabres, B, Maeda, N, Hara, H, Scobie, L, Gianello, P, Takeuchi, Y, Yamada, K, Hwang, ES, Kim, SJ & Park, CG 2014, 'The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation', Xenotransplantation, vol. 21, no. 5, pp. 420-430. https://doi.org/10.1111/xen.12129

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T1 - The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation

AU - Kim, Mee Kum

AU - Choi, Hyuk Jin

AU - Kwon, Ivo

AU - Pierson, Richard N.

AU - Cooper, David K.C.

AU - Soulillou, Jean Paul

AU - O'Connell, Philip J.

AU - Vabres, Bertrand

AU - Maeda, Naoyuki

AU - Hara, Hidetaka

AU - Scobie, Linda

AU - Gianello, Pierre

AU - Takeuchi, Yasuhiro

AU - Yamada, Kazuhiko

AU - Hwang, Eung Soo

AU - Kim, Sang Joon

AU - Park, Chung Gyu

PY - 2014/9/1

Y1 - 2014/9/1

N2 - 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.

AB - 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.

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KW - ethics

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KW - regulation

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JO - Xenotransplantation

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The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation

Abstract

Bibliographical note

Keywords

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