Key issues related to clinical trials of xenotransplantation
许皓 1张玄 1窦科峰 1李静
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作者信息
1. 空军军医大学西京医院肝胆外科，西安 710032
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摘要
异种移植的发展有望缓解供体器官短缺的状况。目前，基因编辑猪被认为是临床异种移植的理想供体器官来源。在相关技术的推动下，异种移植临床前研究取得了实质性成果，这为开启早期临床试验创造了良好条件。特别是近两年，国外该领域的临床研究取得了突破性进展。本文简要概述了国内外异种移植的临床应用进展，从供体猪基因编辑、受试者全程管理原则、伦理和社会心理学三方面讨论异种移植临床试验的关键问题。相信在多学科交叉融合的背景下，未来异种移植将逐步转入临床应用，更好地造福人类。 The development of xenotransplantation is expected to alleviate the supply and demand gap of donors′ organs. Currently,gene-edited pigs are considered as ideal organ donor source for clinical xenotransplantation. Driven by relevant technologies,substantial progress have been achieved in preclinical studies of xenotransplantation,which creates good conditions for the opening of early clinical trials. Especially in recent two years,the foreign clinical research in this field has made a breakthrough. Here,the progress in xenotransplantation of clinical trials is briefly reviewed home and abroad,the key issues in clinical trials of xenotransplantation are discussed from the perspectives of gene editing of donor pigs,principles of whole-course management of subjects,ethics and social psychology issue. It is believed that under the background of multidisciplinary cross-fusion,xenotransplantation will be gradually transferred to clinical application in the future,and better benefit human beings.
Abstract
The development of xenotransplantation is expected to alleviate the supply and demand gap of donors′ organs. Currently,gene-edited pigs are considered as ideal organ donor source for clinical xenotransplantation. Driven by relevant technologies,substantial progress have been achieved in preclinical studies of xenotransplantation,which creates good conditions for the opening of early clinical trials. Especially in recent two years,the foreign clinical research in this field has made a breakthrough. Here,the progress in xenotransplantation of clinical trials is briefly reviewed home and abroad,the key issues in clinical trials of xenotransplantation are discussed from the perspectives of gene editing of donor pigs,principles of whole-course management of subjects,ethics and social psychology issue. It is believed that under the background of multidisciplinary cross-fusion,xenotransplantation will be gradually transferred to clinical application in the future,and better benefit human beings.
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