Department of Anatomy and Neurobiology, Dalhousie University, Halifax, Nova Scotia B3H 3J5, Canada.
Cell Stem Cell. 2011 May 6;8(5):468-75. doi: 10.1016/j.stem.2011.04.012.
Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, subacute incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial.
盖伦公司最近宣布，已开始招募世界首例涉及源自人类胚胎干细胞（hESC）的细胞的人体临床试验的患者。这项试验提出了有关基于 hESC 治疗方法的未来的重要问题，尤其是在脊髓损伤（SCI）患者中。我们讨论了这项研究的一些安全性和有效性问题，以及公平选择受试者的伦理学问题。我们考虑了其他可能更适合这项研究的人群：慢性完全性 SCI 患者进行安全性试验，亚急性不完全性 SCI 患者进行有效性试验，也许原发性进行性多发性硬化症（MS）患者进行安全性和有效性联合试验。
