AvailABIlity:Europe(1),USA(2),other(3)
Content:7.5mLOverview
CD4isanaccessorymoleculeinvolvedintherecognitionofforeignantigensinassociationwithMHCclassIIantigensbyTcells.ThelpercellsandtoalowerdegreemonocytesanddendriticcellsexpressCD4.
TheClini
MACS®CD4ProductLineconsistsofmurineanti-CD4monoclonalantibodiesconjugatedtosuperparamagneticirondextranparticles.
Onevialcontains7.5mLsterile,non-pyrogenicsolution.
TheperformanceoftheCliniMACSCD4ProductLinedependsontheindividualseparationstrategy.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
TheCliniMACSCD4ProductLinewasdevelopedforthedepletionorenrichmentofCD4+cellsfromhumanheterogeneoushematologiccellpopulationsincombinationwiththeCliniMACSSystem.
Referencedliterature
CD4+Tcellshavebeenusedasthebasisforvariousgenetherapyapproaches,forexample,inthehumanimmunodeficiencyvirus(HIV)setting.1-4
Intheallogeneictransplantationsetting,CD4+Tcellsindonorlymphocyteinfusions(DLI)maybecapableofmountingGvTresponses,concomitantlyreducingtheriskofGvHD5,6andreconstitutingtherecipient’simmunesystem.7Additionally,Th4cellshavebeensuccessfullyusedtosupportstemcellgrafts.8
ThecombineddepletionofCD4+andCD8+Tcellsresultsinacellularproductenrichedforcellsoftheinnateimmunesystem,suchasTCRγ/δTcellsandsubpopulationsofNKcells.9,10Theuseofsuchdonorinnatelymphocyteinfusions(DILI)isaimingatimprovingengraftmentandanti-tumoreffects,whileatthesametimereducingtheriskofGvHD.
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