material relevant materials for材料在材料研究

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1、RelevantmaterialsHTA2004MaterialDescriptionRelevantMaterialsforthepurposesoftheHumanTissueAct2004?AntibodiesNoArtificiallycreatedstemcells*NoBileYesBloodYesBonemarrowYesBones/skeletonsYesBrainYesBreastMilk***YesBreathcondensatesandexhaledgasesNoBuffycoatlayer(interfacelaye

2、rbetweenplasmaandbloodcellswhenbloodisseparated)YesCelllines**NoCellsthathavedividedincultureNoCSF(Cerebrospinalfluid)YesCysticfluidYesDNANoEggs*NoEmbryonicstemcells(cellsderivedfromanembryo)**NoEmbryos(outsidethebody)*NoExtractedmaterialfromcells,e.g.nucleicacids,cytoplas

3、micfractions,celllysates,organelles,proteins,carbohydratesandlipids.NoFaecesYesFetaltissueYesFluidfromcysticlesionsYesGametes*No7/13/2021RelevantmaterialsHTA2004Hair(fromdeceasedperson)YesHair(fromlivingperson)NoJointaspiratesYesLysedcellsNoMucusYesNail(fromdeceasedperson)

4、YesNail(fromlivingperson)NoNasalandbronchiallavageYesNonbloodderivedstemcells(i.e.derivedfromthebody.)YesNonfetalproductsofconception(i.e.theamnioticfluid,umbilicalcord,placentaandmembranes)YesOrgansYesPericardialfluidYesPlasma(Pleasenote:Dependingonhowplasmaispreparedandp

5、rocessed,itmaycontainsmallnumbersofplateletsandotherbloodcells.Ifanyofthesecellsarepresentthentheplasmamustberegardedasrelevantmaterial.)NoPlateletsYesPleuralfluidYesPrimarycellcultures(wholeexplant/biopsypresent)YesPusYesRNANoSalivaYesSerumNoSkinYesSperm*No7/13/2021Releva

6、ntmaterialsHTA2004Sputum(orphlegm)YesStomachcontentsYesTeethYesTumourtissuesamplesYesUmbilicalcordbloodstemcellsYesUrineYes*WhileoutsidethedefinitionofrelevantmaterialforthepurposesoftheHTAct,thesematerialsfallundertheremitoftheHumanFertilisationandEmbryologyAct1990,andare

7、regulatedbytheHumanFertilisationandEmbryologyAuthority(HFEA).**CelllinesandembryonicstemcelllinesfallwithintheregulatoryremitoftheHTAbyvirtueoftheHumanTissue(QualityandSafetyforHumanApplication)Regulations2007,whichregulatestheprocessing,storageanddistributionofstemcelllin

8、esforhumanapplication.BoththeHFEAandtheMedicinesandHealthcareproductsRegulatoryAgency(MHR