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
收藏
页码：175 / 198
页数：24
相关论文
共 50 条
  • [1] Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies
    Barazzetti, Gaia
    Hurst, Samia A.
    Mauron, Alexandre
    STEM CELLS TRANSLATIONAL MEDICINE, 2016, 5 (08) : 1058 - 1066
  • [2] Effects of Long-Term Culture on Human Embryonic Stem Cell Aging
    Xie, Xiaoyan
    Hiona, Asimina
    Lee, Andrew Stephen
    Cao, Feng
    Huang, Mei
    Li, Zongjin
    Cherry, Athena
    Pei, Xuetao
    Wu, Joseph C.
    STEM CELLS AND DEVELOPMENT, 2011, 20 (01) : 127 - 138
  • [3] Target Populations for First-In-Human Embryonic Stem Cell Research in Spinal Cord Injury
    Bretzner, Frederic
    Gilbert, Frederic
    Baylis, Francoise
    Brownstone, Robert M.
    CELL STEM CELL, 2011, 8 (05) : 468 - 475
  • [4] The inherent ethical challenge of first-in-human pluripotent stem cell trials
    Habets, Michelle G. J. L.
    van Delden, Johannes J. M.
    Bredenoord, Annelien L.
    REGENERATIVE MEDICINE, 2014, 9 (01) : 1 - 3
  • [5] Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy
    Chapman, Audrey R.
    Scala, Courtney C.
    KENNEDY INSTITUTE OF ETHICS JOURNAL, 2012, 22 (03) : 243 - 261
  • [6] Long-Term, Stable Differentiation of Human Embryonic Stem Cell-Derived Neural Precursors Grafted into the Adult Mammalian Neostriatum
    Nasonkin, Igor
    Mahairaki, Vasiliki
    Xu, Leyan
    Hatfield, Glen
    Cummings, Brian J.
    Eberhart, Charles
    Ryugo, David K.
    Maric, Dragan
    Bar, Eli
    Koliatsos, Vassilis E.
    STEM CELLS, 2009, 27 (10) : 2414 - 2426
  • [7] Bright ferritin for long-term MR imaging of human embryonic stem cells
    Zhuang, Keyu
    Romagnuolo, Rocco
    Valdman, Tamilla Sadikov
    Vollett, Kyle D. W.
    Szulc, Daniel A.
    Cheng, Hai-Ying Mary
    Laflamme, Michael A.
    Cheng, Hai-Ling Margaret
    STEM CELL RESEARCH & THERAPY, 2023, 14 (01)
  • [8] Function of Mouse Embryonic Stem Cell-Derived Supporting Cells in Neural Progenitor Cell Maturation and Long Term Cxpansion
    Guan, Yunqian
    Du, Qing-An
    Zhu, Wanwan
    Zou, Chunlin
    Wu, Di
    Chen, Ling
    Zhang, Yu Alex
    PLOS ONE, 2013, 8 (01):
  • [9] Human Neural Stem Cell Transplantation Provides Long-Term Restoration of Neuronal Plasticity in the Irradiated Hippocampus
    Acharya, Munjal M.
    Rosi, Susanna
    Jopson, Timothy
    Limoli, Charles L.
    CELL TRANSPLANTATION, 2015, 24 (04) : 691 - 702
  • [10] Long-Term Safety and Function of RPE from Human Embryonic Stem Cells in Preclinical Models of Macular Degeneration
    Lu, Bin
    Malcuit, Christopher
    Wang, Shaomei
    Girman, Sergej
    Francis, Peter
    Lemieux, Linda
    Lanza, Robert
    Lund, Raymond
    STEM CELLS, 2009, 27 (09) : 2126 - 2135
12345