PDF(Pubmed)
Abstract：
The last few years have seen a significant increase in the use of technology to manipulate genetic sequences and generate animals as a source of xeno-organs. This has made the generation of genetically bespoke organisms a reality. This paper will analyze the regulatory and practical aspects of such an innovative approach to xenotransplantation on the basis of a hypothetical case study applied to Germany and highlight the gaps in the current regulation. This paper thus provides the basis for legal debate within a specific country. In addition, the identified gaps also pose a barrier toward the harmonization of international regulation. This publication therefore lays the groundwork for guiding the international debate regarding the regulatory framework for solid organ xenotransplantation toward specific issues.
摘要：
在过去的几年中，操纵遗传序列并产生动物作为异种器官来源的技术的使用显着增加。这使得基因定制生物的产生成为现实。本文将在应用于德国的假设案例研究的基础上，分析这种异种移植创新方法的监管和实践方面，并强调当前监管中的差距。因此，本文为特定国家内部的法律辩论提供了基础。此外,发现的差距也对国际监管的协调构成障碍。因此，该出版物为指导有关实体器官异种移植监管框架的国际辩论奠定了基础。
