Essentials of Tissue Banking George Galea Editor Essentials of Tissue Banking 123 Editor Dr.GeorgeGalea,MD,FRCP,FRCPath ScottishNationalBloodTransfusionService EllensGlenRoad EdinburghEH177QT UnitedKingdom [email protected] ISBN978-90-481-9141-3 e-ISBN978-90-481-9142-0 DOI10.1007/978-90-481-9142-0 SpringerDordrechtHeidelbergLondonNewYork LibraryofCongressControlNumber:2010931445 ©SpringerScience+BusinessMediaB.V.2010 Nopartofthisworkmaybereproduced,storedinaretrievalsystem,ortransmittedinanyformorby anymeans,electronic,mechanical,photocopying,microfilming,recordingorotherwise,withoutwritten permissionfromthePublisher,withtheexceptionofanymaterialsuppliedspecificallyforthepurpose ofbeingenteredandexecutedonacomputersystem,forexclusiveusebythepurchaserofthework. Printedonacid-freepaper SpringerispartofSpringerScience+BusinessMedia(www.springer.com) Preface Aparadigmshiftistakinginraisingstandardsonallaspectsoftissuebankingfrom procurementtoprocessing,fromstoragetoclinicalusage.Anumberofmonographs haveappearedgivingguidanceonGMPandqualitysystemsthatshouldbeadhered to. There are also good guidelines on the significance of the new regulations that havebeenenacted. However there is a significant lack of information on the scientific basis and rationaleonwhytissuebankingpracticeshavedevelopedthewaytheyhave.Many of them have developed without much validation and have been in use for many years, copied from one tissue bank to another. There are some good articles on somescientificaspectsoftissuebankingpractices,buttheyareinrelativelyoldand in somewhat obscure journals. This book is intended to fill this gap by getting a seriesofeminentexpertstoeachwriteachapterortwoonuptodatetissuebanking practices. Moreover in the modern world of tissue banking, safety and quality of tissues havetakenanincreasinglyimportantrole.Infacttheseactivitiesformthebasisof many licensure activities that relate to tissue establishments. An attempt has been madetocovertheseaspectsaswell. Althoughthelegislationcoversalltypesofcells,includingstemcells,theyhave beendeliberatelyomitted.Thetargetaudiencesforstemcellsaredifferentandthe set up is also generally quite different unlike cord blood, which is very similar to tissuesandthereforeincluded. Inordertolimitthesizeofthebooktoamanageableleveltheauthorshavebeen onlyaskedtocoverthebasisofcurrentpractices,ratherthanfuturedevelopments, such as embryonic cell developments, tissue engineering and gene therapy, which are more cellular therapies than tissue banking, per se. Courses conferring certifi- catesanddiplomashavejuststartedtobeprovidedbyvariousprofessionalbodies. Thisisimportantbecausetissuebankingisbecomingadistinctmodalityforscien- tistswhowanttoworkinthefield.Ibelievesuchanaudiencewouldbeverykeen tousethisbook.Alsoanyscientistandmedicalpersonworkinginthefieldshould beinterestedinit.Itwillalsobeusefulformanysurgeonswhousetissuesintheir dailyclinicalpractice. I am very grateful to all the authors, who without exception willingly gave so muchtime,effortandenergyinwritingtheirchapters.Theyarewithoutexception, v vi Preface leadersintheirfield.Theyhaveallproduceduptodateandstateoftheartchapters. Theyhavedoneitinthestyletheyfeltwasappropriateandnoattemptwasmadeto modifythis.Thekeyobjectivewastocollateallthisinformationinoneplace.Ihave learntalotwhilsteditingthisworkandIhopethatthereaderswillbeengrossedin readingthisbookasmuchasIhave. Edinburgh,Scotland GeorgeGalea Contents PartI Managementof 1 LiveDonorsofTissue . . . . . . . . . . . . . . . . . . . . . . . . . 3 RuthWarwick 2 DeceasedDonorsofTissue . . . . . . . . . . . . . . . . . . . . . . . 23 AuroraNavarro 3 BankingofCordBlood . . . . . . . . . . . . . . . . . . . . . . . . . 41 ElianeGluckman 4 BankingofCorneas. . . . . . . . . . . . . . . . . . . . . . . . . . . 59 W.JohnArmitage 5 BankingofHeartValves . . . . . . . . . . . . . . . . . . . . . . . . 69 RobertParker 6 BankingofSkin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 EllenHeck PartII Principlesof 7 Storage,ProcessingandPreservation . . . . . . . . . . . . . . . . . 95 JohnN.Kearney 8 Cryopreservation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 DavidPegg 9 SterilisationbyIrradiation . . . . . . . . . . . . . . . . . . . . . . 123 ArturKaminski,IzabelaUhrynowska-Tyszkiewicz, andWaclawStachowicz PartIII EnsuringSafetyby 10 TestingtheDonor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 AlanKitchenandJohnBarbara 11 TestingtheTissueandtheEnvironment . . . . . . . . . . . . . . . 167 TedEastlundandMartellK.Winters vii viii Contents PartIV EnsuringQualityby 12 EstablishingaQualitySystem . . . . . . . . . . . . . . . . . . . . . 191 ScottA.Brubaker 13 ITSystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217 LindaLodge PartV LegalandEthicalEnvironment 14 RegulatoryandEthicalIssues . . . . . . . . . . . . . . . . . . . . . 231 DavidPegg Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243 Contributors W.JohnArmitage CTSBristolEyeBank,UniversityofBristol,BristolEye Hospital,BristolBS12LX,UK,[email protected] JohnBarbara NHSBloodandTransplant,ColindaleAvenue,London NW95BG,UK,[email protected] ScottA.Brubaker AmericanAssociationofTissueBanks,McLean,VA22101, USA,[email protected] TedEastlund DepartmentofPathology,UniversityofNewMexicoSchool ofMedicine,Albuquerque,NM87131,USA,[email protected] ElianeGluckman Eurocord,HematologyDepartment,APHPUniversityParis VII,Paris,France,[email protected] EllenHeck TransplantMedicalServices,UTSouthwesternMedicalCenter, Dallas,TX75390-9074,USA,[email protected] ArturKaminski DepartmentofTransplantologyandCentralTissueBank, MedicalUniversityofWarsaw,Warsaw02-004,Poland,[email protected] JohnN.Kearney HeadofTissueServices,NHSBTTissueServices,Liverpool L248RB,UK,[email protected] AlanKitchen NationalTransfusionMicrobiologyReferenceLaboratory,NHS BloodandTransplant,ColindaleAvenue,LondonNW95BG,UK, [email protected] LindaLodge ScottishNationalBloodTransfusionService,EdinburghEH177QT, Scotland,[email protected] AuroraNavarro BancdeSangiTeixits,pgValld’Hebron,119-12908035, Barcelona,Spain,[email protected] RobertParker HeartValveBank,BromptonHospital,SydneyStreet,London SW36NP,UK,[email protected] DavidPegg DepartmentofBiology(Area14),UniversityofYork,YorkYO10 5YW,UK,[email protected] ix
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