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澄清干细胞疗法的获益与风险
Clarifying Stem-cell Therapy's Benefits and Risks


Peter W. Marks ... 其他 • 2017.03.16
相关阅读
• 重振再生医学的监管 • 向消费者直接推销治疗心力衰竭的干细胞疗法 • 自体诱导干细胞来源的视网膜细胞用于治疗黄斑变性 • 干细胞临床应用中的两个极端

当前对干细胞疗法在改善患者结局甚至治愈疾病方面的潜力充满兴奋之情是可以理解的,在美国食品药品监督管理局(Food and Drug Administration,FDA)工作的我们也感到兴奋。但是,为确保这一新兴领域实现其对患者的承诺,我们必须首先基于可靠的科学,了解其风险与获益,并且开发治疗方法。如果不遵循已经帮助医学取得巨大进步的、充分证据的产生原则,那么我们或许永远看不到干细胞疗法的潜力完全转化为现实。





作者信息

Peter W. Marks, M.D., Ph.D., Celia M. Witten, Ph.D., M.D., and Robert M. Califf, M.D.
From the Food and Drug Administration, Silver Spring, MD.

 

参考文献

1. Nguyen PK, Rhee JW, Wu JC. Adult stem cell therapy and heart failure, 2000 to 2016: a systematic review. JAMA Cardiol 2016;1:831-841

2. Locatelli F, Algeri M, Trevisan V, Bertaina A. Remestemcel-L for the treatment of graft versus host disease. Expert Rev Clin Immunol 2016;29:1-14

3. Berkowitz AL, Miller MB, Mir SA, et al. Glioproliferative lesion of the spinal cord as a complication of “stem-cell tourism.” N Engl J Med 2016;375:196-198

4. Thirabanjasak D, Tantiwongse K, Thorner PS. Angiomyeloproliferative lesions following autologous stem cell therapy. J Am Soc Nephrol 2010;21:1218-1222

5. Albini T, Kuriyan AE, Townsend JH, et al. Vision loss consequent to intravitreal stem cell injection. Presented at the American Academy of Ophthalmology Annual Meeting, Las Vegas, November 13–14, 2015.

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