Department of Molecular Biosciences, University of California Davis, Davis, CA, 95616, USA.
Center of Excellence for Aging & Brain Repair, Department of Neurosurgery and Brain Repair, University of South Florida College of Medicine, Tampa, FL, 33612, USA.
Stem Cell Rev Rep. 2017 Apr;13(2):192-197. doi: 10.1007/s12015-016-9716-y.
Stem cell therapy for stroke has advanced from the laboratory to the clinic, but remains as an experimental treatment. Two lines of transplant regimens have emerged, namely the "early bird" peripheral injections in subacute stroke patients and the "late night" direct intracerebral treatments in chronic stroke patients. Autologous bone marrow-derived stem cells, which only required minimal manipulations during graft cell preparation, gained fast-track entry into the clinic, while gene modified stem cells necessitated overcoming more stringent regulatory criteria before they were approved for clinical use. Safety of the stem cell therapy can be declared from these clinical trials, but efficacy warrants further investigations. Here, we offer insights into the translation of cell therapy from the laboratory to the clinic, in the hopes that highlighting the lessons we learned from this experience will guide the optimization of functional outcomes of future clinical trials of stem cell therapy for stroke.
干细胞疗法治疗中风已从实验室走向临床，但仍属于实验性治疗。两种移植方案已经出现，即亚急性期中风患者的“早期鸟”外周注射和慢性期中风患者的“深夜”直接脑内治疗。自体骨髓源性干细胞在移植物细胞制备过程中仅需进行最小程度的操作，迅速进入临床应用，而基因修饰的干细胞在获得临床使用批准之前需要克服更严格的监管标准。这些临床试验可以证明干细胞疗法的安全性，但疗效仍需要进一步研究。在这里，我们提供了将细胞疗法从实验室转化到临床的见解，希望从这些经验中吸取的教训将指导未来中风干细胞治疗临床试验中优化功能结果。
