Hommes O R
European Charcot Foundation, Hoeveveld 18A, 6584 GG Molenhoek (Nijmegen area), The Netherlands.
J Neurol Sci. 2008 Feb 15;265(1-2):136-9. doi: 10.1016/j.jns.2007.08.019. Epub 2007 Sep 29.
A crucial point in development of new treatments is the step from the experimental level to the first clinical trials. For stem cell treatments in general, but for stem cell treatment in Multiple Sclerosis specifically, this is the question for the moment. To answer this question a rational analysis of the hypotheses and the suppositions behind the application of stem cells is necessary, as well as a review of the present knowledge, the risks and the gains to be expected. This is a personal analysis of 32 oral presentation and discussions of the European Charcot Foundation Symposium, Taormina 2006. It is the application of the Kenter and Cohen [Kenter MJH, Cohen AF. Establishing risk of human experimentation with drugs: lessons from TGN 1412. Lancet 2006; 368:1387-91] approach, adapted for stem cell treatment in MS. About half of the pertinent issues plead for the start of clinical experiments now. However, the absence of knowledge on deleterious effects and their predictability heavily weights against it. Organisational and funding aspects were discussed to prevent uncritical, uncontrolled clinical approaches.
新疗法研发中的一个关键点是从实验阶段迈向首次临床试验。对于一般的干细胞治疗而言，尤其是针对多发性硬化症的干细胞治疗，当下正面临这一问题。为回答这个问题，有必要对干细胞应用背后的假设和推测进行合理分析，同时回顾现有知识、预期风险和收益。这是对2006年在陶尔米纳举行的欧洲夏科基金会研讨会上32场口头报告及讨论的个人分析。它采用了肯特和科恩[肯特MJH，科恩AF。确定药物人体实验的风险：从TGN 1412中吸取的教训。《柳叶刀》2006年；368:1387 - 91]的方法，并针对多发性硬化症的干细胞治疗进行了调整。大约一半的相关问题支持现在就开展临床试验。然而，对有害影响及其可预测性的了解不足严重阻碍了这一进程。会上还讨论了组织和资金方面的问题，以防止不严谨、无控制的临床方法出现。
