Key anticipated regulatory issues for clinical use of human induced pluripotent stem cells.
Key anticipated regulatory issues for clinical use of human induced pluripotent stem cells.
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DOI：
10.2217/rme.12.51
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发表时间：
2012-09
影响因子：
2.7
通讯作者：
Knoepfler PS
中科院分区：
文献类型：
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作者：
Knoepfler PS
人类诱导多能干细胞(HiPSCs)的产生极大地扩展了基于干细胞的再生医学治疗的可能领域，并在自体治疗方面具有特别令人兴奋的潜力。然而，未来基于hiPSCs的疗法不仅必须解决与美国FDA和国际监管机构面临的人类胚胎干细胞类似的监管问题，而且hiPSCs也提出了独特的担忧。虽然HiPSCs的第一次临床应用仍在继续，但作为一个领域，我们应该预测潜在的障碍并开始制定解决方案，这将是明智的。在这篇文章中，我讨论了HiPSC面临的潜在监管问题，并提出了一些潜在的应对方向的变化。
The production of human induced pluripotent stem cells (hiPSCs) has greatly expanded the realm of possible stem cell-based regenerative medicine therapies and has particularly exciting potential for autologous therapies. However, future therapies based on hiPSCs will first have to address not only similar regulatory issues as those facing human embryonic stem cells with the US FDA and international regulatory agencies, but also hiPSCs have raised unique concerns as well. While the first possible clinical use of hiPSCs remains down the road, as a field it would be wise for us to anticipate potential roadblocks and begin formulating solutions. In this article, I discuss the potential regulatory issues facing hiPSCs and propose some potential changes in the direction of the field in response.