G-CSF Prevents the Progression of Structural Disintegration of White Matter Tracts in Amyotrophic Lateral Sclerosis A Pilot Trial 英文参考文献.docVIP

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G-CSF Prevents the Progression of Structural Disintegration of White Matter Tracts in Amyotrophic Lateral Sclerosis A Pilot Trial 英文参考文献.doc

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G-CSF Prevents the Progression of Structural Disintegration of White Matter Tracts in Amyotrophic Lateral Sclerosis A Pilot Trial 英文参考文献

G-CSFPreventstheProgressionofStructural DisintegrationofWhiteMatterTractsinAmyotrophic LateralSclerosis:APilotTrial ThomasDuning1*.,HagenSchiffbauer2.,TobiasWarnecke1,SiawooshMohammadi1,AgnesFloel3,4,5, KatjaKolpatzik1,HaraldKugel2,ArminSchneider6,StefanKnecht1,MichaelDeppe1,WolfRu¨diger Scha¨bitz1,7 1Department ofNeurology, University Hospital Muenster,Muenster, Germany, 2Department ofClinical Radiology, University Hospital Muenster,Muenster, Germany, 3Department of Neurology, Charite′ - Universitaetsmedizin Berlin, Berlin, Germany, 4Center for Stroke Research Berlin, Charite′ - Universitaetsmedizin Berlin, Berlin, Germany, 5Cluster of Excellence NeuroCure, Charite′ - Universitaetsmedizin Berlin, Berlin, Germany, 6SYGNIS Bioscience, Heidelberg, Germany, 7Department of Neurology,EVKBielefeld,Bielefeld,Germany Abstract Background: The hematopoietic protein Granulocyte-colony stimulating factor (G-CSF) has neuroprotective and - regenerativeproperties.TheG-CSFreceptorisexpressedbymotoneurons,andG-CSFprotectsculturedmotoneuronalcells fromapoptosis.Itthereforeappearsasanattractiveandfeasibledrugcandidateforthetreatmentofamyotrophiclateral sclerosis (ALS). The current pilot study was performed to determine whether treatment with G-CSF in ALS patients is feasible. Methods:TenpatientswithdefiniteALSwereenteredintoadouble-blind,placebo-controlled,randomizedtrial.Patients receivedeither10mg/kgBWG-CSForplacebosubcutaneouslyforthefirst10daysandfromday20to25ofthestudy. ClinicaloutcomewasassessedbychangesintheALSfunctionalratingscale(ALSFRS),acomprehensiveneuropsychological testbattery,andbyexamininghandactivitiesofdailylivingoverthecourseofthestudy(100days).Thetotalnumberof adverse events (AE) and treatment-related AEs, discontinuation due to treatment-related AEs, laboratory parameters including leukocyte, erythrocyte, and platelet count, as well as vital signs were examined as safety endpoints. Further- more, we explored potential effects of G-CSF on structural cerebral abn