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

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)420-430
Number of pages11
JournalXenotransplantation
Volume21
Issue number5
DOIs
Publication statusPublished - Oct 2014

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Heterologous Transplantation
Transplantation
Clinical Trials
Guidelines
Ethical Review

Keywords

  • xenotransplantation
  • clinical trials
  • xenocorneal transplantation

Cite this

Kim, Mee Kum ; Choi, Hyuk Jin ; Kwon, Ivo ; Pierson, Richard N. ; Cooper, David K. C. ; Soulillou, Jean-Paul ; O'Connell, Philip J. ; Vabres, Bertrand ; Maeda, Naoyuki ; Hara, Hidetaka ; Scobie, Linda ; Gianello, Pierre ; Takeuchi, Yasuhiro ; Yamada, Kazuhiko ; Hwang, Eung-Soo ; Kim, Sang Joon ; Park, Chung-Gyu . / The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation. In: Xenotransplantation. 2014 ; Vol. 21, No. 5. pp. 420-430.
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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.",
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Kim, MK, Choi, HJ, Kwon, I, Pierson, RN, Cooper, DKC, Soulillou, J-P, O'Connell, PJ, Vabres, B, Maeda, N, Hara, H, Scobie, L, Gianello, P, Takeuchi, Y, Yamada, K, Hwang, E-S, Kim, SJ & Park, C-G 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

The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation. / Kim, Mee Kum; Choi, Hyuk Jin; Kwon, Ivo; Pierson, Richard N.; Cooper, David K. C. ; Soulillou, Jean-Paul; O'Connell, Philip J. ; Vabres, Bertrand; Maeda, Naoyuki ; Hara, Hidetaka; Scobie, Linda; Gianello, Pierre; Takeuchi, Yasuhiro ; Yamada, Kazuhiko ; Hwang, Eung-Soo; Kim, Sang Joon; Park, Chung-Gyu .

In: Xenotransplantation, Vol. 21, No. 5, 10.2014, p. 420-430.

Research output: Contribution to journalArticle

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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

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