RISK OF TUMORIGENESIS IN FIRST-IN-HUMAN TRIALS OF EMBRYONIC STEM CELL NEURAL DERIVATIVES: ETHICS IN THE FACE OF LONG-TERM UNCERTAINTY

被引：21

作者：

Hess, Pascale G. ^{[1
]}

机构：

[1] Dalhousie Univ, Halifax, NS B3H 3P7, Canada

来源：

ACCOUNTABILITY IN RESEARCH-POLICIES AND QUALITY ASSURANCE | 2009年 / 16卷 / 04期

基金：

加拿大健康研究院;

关键词：

clinical trials; ethics; human embryonic stem cells; neurodegenerative diseases; spinal cord injury; IN-VITRO DIFFERENTIATION; GENE-TRANSFER; ES CELLS; TRANSPLANTATION; DEPRESSION; SAFETY; MODEL;

D O I：

10.1080/08989620903065145

中图分类号：

R-052 [医学伦理学];

学科分类号：

0101 ; 120402 ;

摘要：

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.

引用

页码：175 / 198

页数：24

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