【英文标准名称】:StandardGuideforQuantitatingCellViabilityWithinBiomaterialScaffolds
【原文标准名称】:测定生物材料支架内细胞活性的标准指南
【标准号】:ASTMF2739-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.43
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:Thenumberanddistributionofviableandnon-viablecellswithin,oronthesurfaceof,abiomaterialscaffoldisoneofseveralimportantcharacteristicsthatmaydetermineinvivoproductperformanceofcell/biomaterialconstructs(see5.7);thereforethereisaneedforstandardizedtestmethodstoquantitatecellviability.Thereareavarietyofstaticanddynamicmethodstoseedcellsonscaffolds,eachwithdifferentcellseedingefficiencies.Ingeneral,staticmethodssuchasdirectpipettingofcellsontoscaffoldsurfaceshavebeenshowntohavelowercellseedingefficienciesthandynamicmethodsthatpushcellsintothescaffoldinterior.Dynamicmethodsinclude:injectionofcellsintothescaffold,cellseedingonbiomaterialscontainedinspinnerflasksorperfusionchambers,orseedingthatisenhancedbytheapplicationofcentrifugalforces.Themethodsdescribedinthisguidecanassistinestablishingcellseedingefficienciesasafunctionofseedingmethodandforstandardizingviablecellnumberwithinagivenmethodology.AsdescribedinGuideF2315,thickscaffoldsorscaffoldshighlyloadedwithcellsleadtodiffusionlimitationsduringcultureorimplantationthatcanresultincelldeathinthecenteroftheconstruct,leavingonlyanouterrimofviablecells.Spatialvariationsofviablecellssuchasthismaybequantitatedusingthetestswithinthisguide.Theeffectivenessoftheculturingmethodorbioreactorconditionsontheviabilityofthecellsthroughoutthescaffoldcanalsobeevaluatedwiththemethodsdescribedinthisguide.Thesetestmethodscanbeusedtoquantitatecellsonhardorsoft3-Dbiomaterials,suchasceramicsandpolymergels.Thetestmethodsalsoapplytocellsseededonporouscoatings.Testmethodsdescribedinthisguidemayalsobeusedtodistinguishbetweenproliferatingandnon-proliferatingviablecells.ProliferatingcellsproceedthroughtheDNAsynthesis(S)phaseandthemitosis(M)phasetoproducetwodaughtercells.Non-proliferatingviablecellsareinsomephaseofthecellcycle,butarenotnecessarilyproceedingthroughthecellcycleculminatinginproliferation.Viablecellsmaybeunderstressorundergoingapoptosis.Assaysforevaluatingcellstressorapoptosisarenotaddressedinthisguide.WhilecellviabilityisanimportantcharacteristicofaTEMP,thebiologicalperformanceofaTEMPisdependantonadditionalparameters.Additionalteststoevaluateandconfirmthecellidentity,proteinexpression,geneticprofile,lineageprogression,extentofdifferentiation,activationstatus,andmorphologyarerecommended.FundamentalbiocompatibilitytestingofthescaffoldmaterialitselfasdescribedinPracticeF748shouldbecompletedpriortousingthebiomaterialwithcells.1.1Thisguideisaresourceofcellviabilitytestmethodsthatcanbeusedtoassessthenumberanddistributionofviableandnon-viablecellswithinporousandnon-porous,hardorsoftbiomaterialscaffolds,suchasthoseusedintissueengineeredmedicalproducts(TEMPs).1.2Inadditiontoprovidingacompendiumofavailabletechniques,thisguidedescribesmaterialsspecificinteractionswiththecellassaysthatcaninterferewithaccuratecellviabilityanalysis,andincludesguidanceonhowtoavoid,and/oraccountfor,scaffoldmaterial/cellviabilityassayinteractions.1.3Thesemethodscanbeusedfor3-Dscaffoldscontainingcellsthathavebeenculturedinvitroorforscaffold/cellconstructsthatareretrievedafterimplantationinlivingorganisms.1.4Thisguidedoesnotproposeacceptancecriteriabasedontheapplicationofcellviabilitytestmethods.1.5ThevaluesstatedinSIunitsaretob......
【中国标准分类号】:C45
【国际标准分类号】:07_100_99
【页数】:6P.;A4
【正文语种】:英语