Establishing a stem cell culture laboratory for clinical trials

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorSEKIYA, Elíseo Joji
dc.contributor.authorFORTE, Andresa
dc.contributor.authorKüHN, Telma Ingrid Borges de Bellis
dc.contributor.authorJANZ, Felipe
dc.contributor.authorBYDLOWSKI, Sérgio Paulo
dc.contributor.authorALVES, Adelson
dc.date.accessioned2014-07-03T20:29:24Z
dc.date.available2014-07-03T20:29:24Z
dc.date.issued2012
dc.description.abstractAdult stem/progenitor cells are found in different human tissues. An in vitro cell culture is needed for their isolation or for their expansion when they are not available in a sufficient quantity to regenerate damaged organs and tissues. The level of complexity of these new technologies requires adequate facilities, qualified personnel with experience in cell culture techniques, assessment of quality and clear protocols for cell production. The rules for the implementation of cell therapy centers involve national and international standards of good manufacturing practices. However, such standards are not uniform, reflecting the diversity of technical and scientific development. Here standards from the United States, the European Union and Brazil are analyzed. Moreover, practical solutions encountered for the implementation of a cell therapy center appropriate for the preparation and supply of cultured cells for clinical studies are described. Development stages involved the planning and preparation of the project, the construction of the facility, standardization of laboratory procedures and development of systems to prevent cross contamination. Combining the theoretical knowledge of research centers involved in the study of cells with the practical experience of blood therapy services that manage structures for cell transplantation is presented as the best potential for synergy to meet the demands to implement cell therapy centers.
dc.description.indexPubMed
dc.identifier.citationREVISTA BRASILEIRA DE HEMATOLOGIA E HEMOTERAPIA, v.34, n.3, p.236-241, 2012
dc.identifier.doi10.5581/1516-8484.20120057
dc.identifier.issn1516-8484
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/5584
dc.language.isoeng
dc.publisherAssociação Brasileira de Hematologia e Hemoterapia e da
dc.relation.ispartofRevista Brasileira de Hematologia e Hemoterapia
dc.rightsopenAccess
dc.rights.holderCopyright Associação Brasileira de Hematologia e Hemoterapia e da
dc.subjectStem cells
dc.subjectTissue therapy
dc.subjectCell culture techniques
dc.subjectGood manufacturing practices
dc.subject.wosHematology
dc.subject.wosMedicine, Research & Experimental
dc.titleEstablishing a stem cell culture laboratory for clinical trials
dc.typearticle
dc.type.categoryreview
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.author.externalSEKIYA, Elíseo Joji:Instituto de Ensino e Pesquisa São Lucas, São Paulo, BRAZIL
hcfmusp.author.externalFORTE, Andresa:CordCell Centro de Terapia Celular, São Paulo, BRAZIL
hcfmusp.author.externalKüHN, Telma Ingrid Borges de Bellis:CordCell Centro de Terapia Celular, São Paulo, BRAZIL
hcfmusp.author.externalJANZ, Felipe:Universidade de São Paulo, São Paulo, BRAZIL
hcfmusp.author.externalALVES, Adelson:Hemocentro São Lucas, São Paulo, BRAZIL
hcfmusp.citation.scopus15
hcfmusp.contributor.author-fmusphcSERGIO PAULO BYDLOWSKI
hcfmusp.description.beginpage236
hcfmusp.description.endpage241
hcfmusp.description.issue3
hcfmusp.description.volume34
hcfmusp.origemSciELO
hcfmusp.origem.pubmed23049427
hcfmusp.origem.scieloSCIELO:S1516-84842012000300018
hcfmusp.origem.scopus2-s2.0-84864318146
hcfmusp.publisher.citySÃO JOSÉ DO RIO PRETO
hcfmusp.publisher.countryBRAZIL
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