Korean Xenocorneal Transplantation Consensus Statement: Ethical and Regulatory Guidelines in Clinical Trials
Narrative Responses:
Purpose
We aimed to establish the consensus about the conditions for undertaking clinical trials in xenocorneal transplantation in Korea.
Methods
Specific issues regarding the xenocorneal transplantation on ethical and regulatory aspects are addressed and the guidelines to conduct clinical trial of the xenocorneal transplantation are proposed.
Results
We review the key ethical requirements and progress of a Korean regulatory framework for clinical trials of xenocorneal transplantation. Consensus was made for recommendations on source pigs, quality control of porcine corneal procurement, preclinical efficacy required to justify a clinical trial, strategies to prevent transmission of porcine endogenous retrovirus, patient selection for clinical trials, and informed consent in xenocorneal transplantation using either cellularized or decellularized porcine graft. The consensus statement of the inclusion criteria for the patients selection has been made by the executive board members in Korean External Eye Disease Society.
Conclusion
This consensus statement will be a good initiative for Korean Food and Drug Administration to discuss final regulatory guidelines in conducting clinical trials of xenocorneal transplantation in Korea, and for International Society to develop international consensus standards of xenocorneal transplantation.