自体成体干细胞临床应用的监管：国际法规的经验教训。
Oversight for clinical uses of autologous adult stem cells: lessons from international regulations.
机构信息
Asia Research Institute, National University of Singapore, Singapore 259770, Singapore.
出版信息
Cell Stem Cell. 2013 Dec 5;13(6):647-51. doi: 10.1016/j.stem.2013.11.013.
PMID:24315438
Abstract
Autologous adult stem cells (ASCs) are being administered by physicians for indications that have not been demonstrated as safe and effective in formal clinical trials. Examination of regulatory frameworks across five countries suggests that balancing the demands of research with clinical freedom has created structural weaknesses that are being exploited.
摘要
自体成体干细胞（ASCs）正由医生用于尚未在正规临床试验中证明安全有效的适应症。对五个国家的监管框架的审查表明，在平衡研究需求与临床自由方面存在结构上的弱点，这些弱点正在被利用。
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