1 CABIMER (Centro Andaluz de Biología Molecular y Medicina Regenerativa) , Seville, Spain .
Stem Cells Dev. 2014 Jan 1;23(1):1-4. doi: 10.1089/scd.2013.0266. Epub 2013 Oct 4.
Halting the first clinical trial on the use of embryonic stem cell derivatives for spinal cord injury resulted in disappointment and created concerns about the future use of pluripotent stem cell-based therapy in the treatment of human diseases. This article presents reflections and concerns related to the halted embryonic stem cell-based clinical trial and discusses some important and controversial issues for achieving safe and successful cell therapy. This manuscript highlights two important points for successful translation of pluripotent stem cell-based therapy in clinics: (i) reproducible xeno-free growth and differentiation of pluripotent stem cells in good manufacturing practice conditions as the prerequisites to ensure a defined and controlled cell source and (ii) extensive studies in small and large animal models and comprehensive basic studies to determine any adverse or toxic effects of transplanted cells, especially teratoma formation, in addition to improving surgical procedure and cell delivery system.
中止首个使用胚胎干细胞衍生物治疗脊髓损伤的临床试验，令人失望，并引发了对多能干细胞为基础的治疗方法在人类疾病治疗中未来应用的担忧。本文针对中止的胚胎干细胞临床试验提出了一些反思和关注，并讨论了实现安全有效的细胞治疗的一些重要而有争议的问题。本文强调了多能干细胞为基础的治疗方法在临床上成功转化的两个重要方面：（i）多能干细胞在良好生产规范条件下可重复无动物成分的生长和分化，作为确保明确和可控的细胞来源的前提条件；（ii）在小型和大型动物模型中进行广泛的研究以及全面的基础研究，以确定移植细胞的任何不良或毒性作用，特别是畸胎瘤的形成，除了改进手术程序和细胞递送系统。
