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

Identifieur interne : 004615 ( Main/Exploration ); précédent : 004614; suivant : 004616

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

Auteurs : Mee Kum Kim [Corée du Sud] ; Hyuk Jin Choi [Corée du Sud] ; Ivo Kwon [Corée du Sud] ; Richard N. Pierson Iii [États-Unis] ; David K. C. Cooper [États-Unis] ; Jean-Paul Soulillou [France] ; Philip J. O'Connell [Australie] ; Bertrand Vabres [France] ; Naoyuki Maeda [Japon] ; Hidetaka Hara [États-Unis] ; Linda Scobie [Royaume-Uni] ; Pierre Gianello [Belgique] ; Yasuhiro Takeuchi [Royaume-Uni] ; Kazuhiko Yamada [États-Unis] ; Eung-Soo Hwang [Corée du Sud] ; Sang Joon Kim [Corée du Sud] ; Chung-Gyu Park [Corée du Sud]

Source :

RBID : ISTEX:4CFB1A3973FF6CDF4D4D1F2163273D43FBB202BC

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.

Url:
DOI: 10.1111/xen.12129


Affiliations:


Links toward previous steps (curation, corpus...)


Le document en format XML

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<div type="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.</div>
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