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22. European Stroke Conference Recent news in stroke research (PO 957 - 962) 957 Recent news in stroke research Baseline Characteristics of Stroke Patients with Atrial Fibrillation How do randomized clinical trials match with settings close to real life? - C.T. Tanislav1, S. Milde2, S Schwartzkopff3, B. Misselwitz4, M. Kaps5 Justus-Liebig-University; Department of Neurology, Giessen, GERMANY1, International Uni-versity Dresden, Dresden, GERMANY2, AOK Hesse, Franfurt, GERMANY3, Hesse Quality Assur-ance (GQH), Frankfurt, GERMANY4, Justus-Liebig-University, Department of Neurology, Giessen, GERMANY5 Background Generalisability of a randomised clinical trial (RCT) is a basic requirement for the translation of the results into a particular clinical setting in routine practice. One of the main determinants of the generalisability are baseline characteristics of the recruited patients. We compare the baseline char-acteristics of patients with nonvalvular atrial fibrillation (AF) accumulated in a large stroke registry with RCT patients taking customary and new oral anticoagulants (oAK) for atrial fibrillation. Methods We analysed baseline data of 15886 stroke patients with AF which were treated between 2004 and 2010 in hospitals of the Federal State of Hesse (Germany) and filed in a statutory stroke data bank. Date reconciliation was performed with a statutory health insurance company in order to extract those individuals who filled an oAK prescription, which was taken as a surrogate marker for oAK treatment. Results The mean age of stroke patients with AF was 77.7 (± 9) years, with a higher proportion of females (58%), Diabetes was documented in 25% of the patients and hypertension was found in 80%. The subgroup which received an oAK prescription was 75.1(± 8) years with comparable burden of vas-cular risk factors. Males received more often oAK (48.1% vrs 41.8%). Conclusions The current evidence for the treatment of patients with AF satisfies insufficiently the requirements in the clinical practice. This regards especially for elderly patients in the secondary stroke prevention. 852 © 2013 S. Karger AG, Basel Scientific Programme 958 Recent news in stroke research Intravenous injection of autologous mesenchymal stem cells after ischemic stroke (ISIS / HER-MES): protocol and progress O. DETANTE1, A. JAILLARD2, A. MOISAN3, I. FAVRE4, M. BARBIEUX5, K. GARAMBOIS6, B. NAEGELE7, P. ANTOINE8, A. KRAINIK9, E.L. BARBIER10, D. PERENNOU11, C. REMY12, M. HOMMEL13, M.J. RICHARD14 University Hospital of Grenoble - Stroke Unit, GRENOBLE, FRANCE1, University Hospital of Grenoble -Research 3T MRI, GRENOBLE, FRANCE2, EFS - Etablissement Français du Sang, GRENOBLE, FRANCE3, University Hospital of Grenoble - Stroke Unit, GRENOBLE, FRANCE4, University Hospital of Grenoble - Stroke Unit, GRENOBLE, FRANCE5, University Hospital of Grenoble - Stroke Unit, GRENOBLE, FRANCE6, University Hospital of Grenoble - Stroke Unit, GRENOBLE, FRANCE7, University Hospital of Grenoble - Stroke Unit, GRENOBLE, FRANCE8, University Hospital of Grenoble - MRI Neuroradiology, GRENOBLE, FRANCE9,Grenoble Institut Neurosciences U 836, GRENOBLE, FRANCE10, University Hospital of Grenoble - Rehabilitation, GRENOBLE, FRANCE11, Grenoble Institut Neurosciences U 836, GRENOBLE, FRANCE12, Uni-versity Hospital of Grenoble - Clinical Research Department, GRENOBLE, FRANCE13, University Hospital of Grenoble - Cell Therapy Unit, GRENOBLE, FRANCE14 Background: Increasing brain plasticity after stroke represents an important strategy to improve functional recovery. Cell therapy, notably using mesenchymal stem cells (MSC), provides a func-tional improvement after cerebral ischemia in rodent models. As preclinical trials, we assessed tol-erance and biodistribution of human MSC after intravenous (IV) injection in rat model (Detante et al., Cell Transplant 2009), and observed cerebral proangiogenic effects (Moisan et al., NMR Biomed 2012). Methods: ISIS study (French HCRP, NCT00875654) is a phase II clinical trial of feasibility and safety of the IV injection of autologous MSC (from bone marrow) one month after ischemic stroke (18-65 year-old; NIHSS > 11). It is a randomized (dynamic treatment allocation), controlled, open trial with a 2 year follow-up. The 3 groups are: treated by “low dose” (100 million of MSC, n=10), treated by “high dose” (300 million of MSC, n=10), and control (n=10). The ancillary HERMES study aims to follow recovery by multimodal MRI (anatomic, activation, vasoreactivity, functional and structural connectivity). Results: 17 patients were included since 2010 (6 “control”, 11 “treated”). Height patients of treated groups received the injection. Only 60 million of MSC were injected for the first patient due to a too short cell culture delay. Three patients did not receive the treatment because of abnormalities (karyo-types) during cell culture. No adverse effects were observed. Conclusion: according to the results of this study, we will conduct a phase III multicentric trial to as-sess efficacy of this cell therapy for stroke.


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