Blight Andrew R, Tuszynski Mark H
Acorda Therapeutics, Hawthorne, New York, USA.
J Neurotrauma. 2006 Mar-Apr;23(3-4):586-93. doi: 10.1089/neu.2006.23.586.
Progress in promoting axonal plasticity and regeneration in animal models of spinal cord injury (SCI) has led to novel prospects for the initiation of human clinical trials in the near future. This review discusses a number of considerations in the path to translating a preclinical candidate from the laboratory to clinical testing. We will also briefly discuss issues associated with the design, performance, analysis, and reporting of human clinical trials in SCI. It is important, for both the medical community and the spinal cord injured community, that objective scientific and medical standards are adopted in the clinical translation of potentially promising, but as yet unproven, therapies for SCI.
脊髓损伤(SCI)动物模型在促进轴突可塑性和再生方面取得的进展,为在不久的将来启动人类临床试验带来了新的前景。本综述讨论了将临床前候选药物从实验室转化为临床试验过程中的一些注意事项。我们还将简要讨论与SCI人类临床试验的设计、实施、分析和报告相关的问题。对于医学界和脊髓损伤群体而言,在对SCI潜在有前景但尚未得到证实的疗法进行临床转化时采用客观的科学和医学标准非常重要。