PDF(Pubmed)
Abstract：
Organ transplantation is a highly utilized treatment for many medical conditions, yet the number of patients waiting for organs far exceeds the number available. The challenges and limitations currently associated with organ transplantation and technological advances in gene editing techniques have led scientists to pursue alternate solutions to the donor organ shortage. Growing human organs in animals and harvesting those organs for transplantation into humans is one such solution. These chimeric animals usually have certain genes necessary for a specific organ\'s development inhibited at an early developmental stage, followed by the addition of cultured pluripotent human cells to fill that developmental niche. The result is a chimeric animal that contains human organs which are available for transplant into a patient, circumventing some of the limitations currently involved in donor organ transplantation. In this review, we will discuss both the current scientific and legal landscape of human-animal chimera (HAC) research. We present an overview of the technological advances that allow for the creation of HACs, the patents that currently exist on these methods, as well as current public attitude and understanding that can influence HAC research policy. We complement our scientific and public attitude discussion with a regulatory overview of chimera research at both the national and state level, while also contrasting current U.S. legislation with regulations in other countries. Overall, we provide a comprehensive analysis of the legal and scientific barriers to conducting research on HACs for the generation of transplantable human organs, as well as provide recommendations for the future.
摘要：
器官移植是许多医疗条件的高度利用的治疗方法，然而，等待器官的患者数量远远超过可用的数量。目前与器官移植相关的挑战和限制以及基因编辑技术的技术进步导致科学家们寻求替代解决方案来解决供体器官短缺。在动物中生长人体器官并收获这些器官以移植到人体内就是这样的解决方案之一。这些嵌合动物通常具有在早期发育阶段抑制特定器官发育所必需的某些基因，然后添加培养的多能人类细胞以填充该发育生态位。结果是一种嵌合动物，其中包含可用于移植到患者体内的人体器官，避免了目前供体器官移植的一些限制。在这次审查中,我们将讨论人类-动物嵌合体（HAC）研究的当前科学和法律环境。我们概述了允许创建HAC的技术进步，这些方法目前存在的专利，以及可能影响HAC研究政策的当前公众态度和理解。我们用国家和州一级的嵌合体研究的监管概述来补充我们的科学和公众态度讨论，同时也将美国现行立法与其他国家的法规进行了对比。总的来说,我们全面分析了进行HAC研究以产生可移植的人体器官的法律和科学障碍，并为未来提供建议。
