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首例人胚胎干细胞神经衍生物临床试验中的肿瘤发生风险:面对长期不确定性的伦理学思考。

Risk of tumorigenesis in first-in-human trials of embryonic stem cell neural derivatives: Ethics in the face of long-term uncertainty.

机构信息

Dalhousie University, Halifax, Canada.

出版信息

Account Res. 2009 Jul;16(4):175-98. doi: 10.1080/08989620903065145.

DOI:10.1080/08989620903065145
PMID:20183160
Abstract

While the successful differentiation of human embryonic stem cells into high purity populations of specialized cells is viewed as a major step towards the safety of prospective human transplantation trials, concerns about the possible risks of tumor formation remain. The potential tumorigenicity of transplants derived from embryonic stem cells raises distinctive ethical challenges regarding trial design, evaluation of their risks to potential benefits ratio, population selection, and post-trial subject monitoring. These challenges are examined within the context of foreseen trials for disorders of the central nervous system.

摘要

虽然将人类胚胎干细胞成功分化为高纯度的特定细胞群体被视为朝着人类前瞻性移植试验的安全性迈出的重要一步,但人们仍然担心可能存在肿瘤形成的风险。胚胎干细胞衍生移植的潜在致瘤性给试验设计、评估其潜在风险与获益比、人群选择以及试验后受试者监测带来了独特的伦理挑战。这些挑战在预期的中枢神经系统疾病临床试验背景下进行了探讨。

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