异种移植的监管障碍。
Regulatory barriers to xenotransplantation.
机构信息
Department of Surgery, Cardiac Xenotransplantation Program, University of Maryland School of Medicine.
Department of Surgery, Johns Hopkins Hospital, Baltimore, Maryland.
出版信息
Curr Opin Organ Transplant. 2019 Oct;24(5):522-526. doi: 10.1097/MOT.0000000000000678.
PURPOSE OF REVIEW
There is a grave discordance between supply and demand for patients with failing organs largely due to an insufficient donor pool for transplantation. Xenotransplantation has been proposed as a solution to bridge this gap.
RECENT FINDINGS
Recent success over the last decade in nonhuman primate models, due to emerging gene-editing technologies combined with novel immunosuppression regimens, has produced promising results in pancreatic islet cell, heart, lung, kidney and liver xenotransplantations.
SUMMARY
As the prospect of xenotransplantation is realized, safety and ethical considerations have come to the forefront of discussion. The WHO and World Health Assembly have encouraged member states to form regulatory bodies to govern human xenotransplantation studies with the highest standards. Here, we summarize the current regulatory landscape governing preclinical advances toward the first human clinical trials.
目的综述：由于可供移植的器官供体不足，衰竭器官患者的供需严重失衡。异种移植被提议作为解决这一差距的方法。
最新发现：由于新兴的基因编辑技术与新型免疫抑制方案相结合，在过去十年中，非人类灵长类动物模型方面取得了成功，这在胰岛细胞、心脏、肺、肾和肝异种移植方面产生了有希望的结果。
总结：随着异种移植的前景成为现实，安全性和伦理问题成为讨论的焦点。世界卫生组织和世界卫生大会鼓励成员国成立监管机构，以最高标准管理人类异种移植研究。在这里，我们总结了当前监管框架，以规范向首例人体临床试验推进的临床前进展。
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