Regulatorystatus:Forresearchuseonly,notforuseinhumans
AvailABIlity:worldwide(2)
Content:5mLOverview
TheCD1c(
BDCA-1)antigenbelongstotheCD1familyandisinvolvedinpresentationoflipidantigens.Inhumanblood,CD1c(BDCA-1)isexclusivelyexpressedonCD11c
highCD123
lowmyeloiddendriticcellsandasmallsubpopulationofCD19
+Bcells.
1Myeloiddendriticcellsrepresentthemajorsubsetofdendriticcellsinhumanperipheralblood(about0.3%ofwhitebloodcells).TheydisplayastrongTcellstimulatoryandcross-presentingcapacity.2–4
TheClini
MACSCD1c(BDCA-1)-BiotinProductLineconsistsofmurineanti-CD1c(BDCA-1)monoclonalantibodiesconjugatedtobiotin.
Onevialcontains5mLsterile,non-pyrogenicsolution.
TheperformanceoftheCliniMACSCD1c(BDCA-1)-BiotinProductLinedependsontheindividualseparationstrategy.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
TheCliniMACSCD1c(BDCA-1)-BiotinProductLinewasdevelopedfortheenrichmentofCD1c(BDCA-1)+myeloiddendriticcellsfromhumanheterogeneoushematologiccellpopulationsincombinationwiththeCliniMACSSystem.
AfterlabelingoftargetcellswiththeCliniMACSCD1c(BDCA-1)-Biotin,theCliniMACSAnti-BiotinReagentisusedforthemagneticenrichmentofCD1c(BDCA-1)+cellsfromthecellularproduct.ACD19+BcelldepletionisrecommendedpriortotheenrichmentofCD1c(BDCA-1)+cells,duetoexpressionofCD1c(BDCA-1)onasubsetofCD19+Bcells.
Referencedliterature
CD1c(BDCA-1)enrichedbloodMDCswereusedinclinicalstudiesforthetreatmentofmelanomaandprostatecancer.5,6