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Autologous Bone Marrow Mononuclear Cell Transplantation in Patients with Decompensated Alcoholic Liver Disease A Randomized Controlled Trial.doc

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Autologous Bone Marrow Mononuclear Cell Transplantation in Patients with Decompensated Alcoholic Liver Disease A Randomized Controlled Trial

AutologousBoneMarrowMononuclearCell TransplantationinPatientswithDecompensated AlcoholicLiverDisease:ARandomizedControlledTrial LaurentSpahr1*,YvesChalandon2,SylvainTerraz3,VincentKindler2,LauraRubbia-Brandt4 ,Jean- LouisFrossard1,RomainBreguet3,NicolasLanthier1,AnnaritaFarina5,JakobPassweg2, ChristophD.Becker3,AntoineHadengue1 1DivisionofGastroenterologyandHepatology,UniversityHospitalsandFacultyofMedicine,Geneva,Switzerland, 2DivisionofHematology,UniversityHospitalsand FacultyofMedicine,Geneva,Switzerland,3DepartmentofRadiology,UniversityHospitalsandFacultyofMedicine,Geneva,Switzerland,4DivisionofClinicalPathology, UniversityHospitalsandFacultyofMedicine,Geneva,Switzerland,5DepartmentofBioinformaticsandStructuralBiology,UniversityHospitalsandFacultyofMedicine, Geneva,Switzerland Abstract Objective:Impairedliverregenerationisassociatedwithapooroutcomeinpatientswithdecompensatedalcoholicliver disease(ALD).Weassessedwhetherautologousbonemarrowmononuclearcelltransplantation(BMMCT)improvedliver functionindecompensatedALD. Design:58patients(meanage54yrs;meanMELDscore19,allwithcirrhosis,81%withalcoholicsteatohepatitisatbaseline liver biopsy) were randomized early after hospital admission to standard medical therapy (SMT) alone (n=30), including steroids in patients with a Maddrey’s score $32, or combined with G-CSF injections and autologous BMMCT into the hepaticartery(n=28).Bonemarrowcellswereharvested,isolatedandreinfusedthesameday.Theprimaryendpointwasa $3pointsdecreaseintheMELDscoreat3months,correspondingtoaclinicallyrelevantimprovementinliverfunction. Liverbiopsywasrepeatedatweek4toassesschangesinKi67+/CK7+hepaticprogenitorcells(HPC)compartment. Results:Bothstudygroupswerecomparableatbaseline.After3months,2and4patientsdiedintheBMMCTandSMT groups,respectively.Adverseeventswereequallydistributedbetweengroups.Moderatealcoholrelapseoccurredin31%of patients.TheMELDscoreimprovedinparallelinbothgroupsduringfollow-upwith18patients(64%)fromtheBMMCT group and 18 pati