Centeno Christopher J, Bashir Jamil
The Centeno-Schultz Clinic, 403 Summit Blvd., Suite 201, Broomfield, CO 80021.
The Centeno-Schultz Clinic, Broomfield, CO.
PM R. 2015 Apr;7(4 Suppl):S4-S7. doi: 10.1016/j.pmrj.2014.12.013.
Stem cells therapies have been in preclinical development for the past 2 decades. A rapidly evolving regulatory landscape has restrained many of these technologies from advancing from the bench to the bedside. Although the large-scale clinical safety of stem cell therapies remains to be fully tested, the total number of patients who have safely received these therapies is large and growing. Prima facie evidence would dictate that certain types of cell therapy are likely safer than others. Understanding the current regulation regarding stem cells involves a discussion of their safety profile, as the 2 issues are closely intertwined.
在过去的20年里，干细胞疗法一直处于临床前开发阶段。快速演变的监管环境阻碍了许多此类技术从实验室走向临床应用。尽管干细胞疗法的大规模临床安全性仍有待全面测试，但已安全接受这些疗法的患者总数众多且在不断增加。初步证据表明，某些类型的细胞疗法可能比其他疗法更安全。由于这两个问题紧密相连，了解当前关于干细胞的监管涉及对其安全性的讨论。
