Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell) A Systematic Review and Meta-Analysis of Clinical Trials 英文参考文献.docVIP

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Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell) A Systematic Review and Meta-Analysis of Clinical Trials 英文参考文献.doc

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Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell) A Systematic Review and Meta-Analysis of Clinical Trials 英文参考文献

SafetyofCellTherapywithMesenchymalStromalCells (SafeCell):ASystematicReviewandMeta-Analysisof ClinicalTrials ManojM.Lalu1,5,LauralynMcIntyre2,5*,ChristinaPugliese5,DeanFergusson5,BrentW.Winston6, JohnC.Marshall7,JohnGranton8,DuncanJ.Stewart3,4,fortheCanadianCriticalCareTrialsGroup 1Department of Anesthesiology, University of Ottawa, Ottawa, Canada, 2Department of Medicine (Division of Critical Care), University of Ottawa, Ottawa, Canada, 3Regenerative Medicine Program, The Ottawa Hospital Research Institute, Ottawa, Canada, 4Department of Cell and Molecular Medicine, University of Ottawa, Ottawa,Canada,5TheOttawaHospitalResearchInstitute,ClinicalEpidemiologyProgram,Ottawa,Canada,6DepartmentofCriticalCareMedicine,UniversityofCalgary, Calgary,Canada,7DepartmentofSurgery(CriticalCare),UniversityofToronto,Toronto,Canada,8DepartmentofMedicine(CriticalCare),UniversityofToronto,Toronto, Canada Abstract Background: Mesenchymal stromalcells(MSCs,‘‘adult stemcells’’)havebeenwidelyusedexperimentally inavariety of clinicalcontexts.Thereisinterestinusingthesecellsincriticalillness,however,thesafetyprofileofthesecellsisnotwell known.WethusconductedasystematicreviewofclinicaltrialsthatexaminedtheuseMSCstoevaluatetheirsafety. Methods and Findings: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (to June 2011), were searched. Prospective clinical trials that used intravascular delivery of MSCs (intravenously or intra-arterially) in adult populationsormixedadultandpediatricpopulationswereidentified.StudiesusingdifferentiatedMSCsoradditionalcell typeswereexcluded.Theprimaryoutcomeadverseeventsweregroupedaccordingtoimmediateevents(acuteinfusional toxicity,fever),organsystemcomplications,infection,andlongertermadverseevents(death,malignancy).2347citations werereviewedand36studiesmetinclusioncriteria.Atotalof1012participantswithclinicalconditionsofischemicstroke, Crohn’s disease, cardiomyopathy, myocardial infarction, graft versus host disease, and healthy v