AvailABIlity:Europe(1),USA(2),other(3)
Content:7.5mLOverview
TheCD8antigen,acoreceptorforMHCclassImolecules,isexpressedstronglyoncytotoxicTcellsanddimlyonasubsetofNKcells.
TheClini
MACS®CD8ProductLineconsistsofmurineanti-CD8monoclonalantibodiesconjugatedtosuperparamagneticirondextranparticles.
Onevialcontains7.5mLsterile,non-pyrogenicsolution.
TheperformanceoftheCliniMACSCD8ProductLinedependsontheindividualseparationstrategy.Forinformationonrespectivecapacities,refertotheCliniMACSUserManualorcontactyourlocalrepresentative.
PleaseinquireaboutrequiredCliniMACSSystemcomponentsandaccessories.
Disclaimer
TheCliniMACS®Systemcomponents,includingReagents,TubingSets,Instruments,andPBS/EDTABuffer,aredesigned,manufacturedandtestedunderaqualitysystemcertifiedtoISO13485.
IntheEU,theCliniMACSSystemcomponentsareavailableasCE-markedmedicaldevicesfortheirrespectiveintendeduse,unlessotherwisestated.TheCliniMACSReagentsandBiotinConjugatesareintendedforinvitrouseonlyandarenotdesignatedfortherapeuticuseordirectinfusionintopatients.TheCliniMACSReagentsincombinationwiththeCliniMACSSystemareintendedtoseparatehumancells.MiltenyiBiotecasthemanufactureroftheCliniMACSSystemdoesnotgiveanyrecommendationsregardingtheuseofseparatedcellsfortherapeuticpurposesanddoesnotmakeanyclaimsregardingaclinicalbenefit.Forthemanufacturinganduseoftargetcellsinhumansthenationallegislationandregulations-e.g.,fortheEUtheDirective2004/23/EC("humantissuesandcells"),ortheDirective2002/98/EC("humanbloodandbloodcomponents")-mustbefollowed.Thus,anyclinicalapplicationofthetargetcellsisexclusivelywithintheresponsibilityoftheuserofaCliniMACSSystem.
IntheUS,theCliniMACSCD34ReagentSystem,includingtheCliniMACSPlusInstrument,CliniMACSCD34Reagent,CliniMACSTubingSetsTSandLS,andtheCliniMACSPBS/EDTABuffer,isFDAapproved;allotherproductsoftheCliniMACSProductLineareavailableforuseonlyunderanapprovedInvestigationalNewDrug(IND)applicationorInvestigationalDeviceExemption(IDE).
CliniMACSMicroBeadsareforresearchuseonlyandnotforhumantherapeuticordiagnosticuse.Unlessotherwisespecificallyindicated,MiltenyiBiotecproductsandservicesareforresearchonlyandnotfortherapeuticordiagnosticuse.
Details
Applications
TheCliniMACSCD8ProductLinewasdevelopedforenrichmentordepletionofCD8+TcellsfromhumanheterogeneoushematologiccellpopulationsincombinationwiththeCliniMACSSystem.
Referencedliterature
IntheallogeneictransplantationsettingCD8+TcellsmayberemovedfromagraftorDLIwiththegoalofpreventingGvHDwhilemaintainingGvLeffects.1-6Inaddition,thistreatmentoptionmayalsobeappliedinordertoemendanunstabledonorchimerismafterSCT.7
ThecombineddepletionofCD4+andCD8+Tcellsresultsinacellularproductenrichedforcellsoftheinnateimmunesystem,suchasTCRγ/δTcellsandsubpopulationsofNKcells.8,9Theuseofsuchdonorinnatelymphocyteinfusions(DILI)isaimingatimprovingengraftmentandanti-tumoreffects,whileatthesametimereducingtheriskofGvHD.
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