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Xenotransplantation. 2014 Sep-Oct;21(5):420-30. doi: 10.1111/xen.12129. Epub 2014 Sep 1.

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

Author information

1
Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea; Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea; Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea.

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

PMID:
25176471
DOI:
10.1111/xen.12129
[Indexed for MEDLINE]

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