title: Can we pass from the experimental to the clinical phase in MS stem cell research?
abstract: 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.
authors: European Charcot Foundation, Hoeveveld 18A, 6584 GG Molenhoek (Nijmegen area), The Netherlands. info@charcot-ms.eu
authors: O R
authors: OR
authors: Hommes
mesh_terms: D000818:Animals; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D006801:Humans; D009103:Multiple Sclerosis / Q000601:surgery*; D033581:Stem Cell Transplantation / Q000379:methods*