Establishing a stem cell culture laboratory for clinical trials
Rev. bras. hematol. hemoter
;
34(3): 236-241, 2012. tab
Artigo
em Inglês
| LILACS
| ID: lil-640875
ABSTRACT
Adult 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.
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Células-Tronco
/
Técnicas de Cultura de Células
/
Boas Práticas de Fabricação
/
Células-Tronco Adultas
/
Terapia Baseada em Transplante de Células e Tecidos
Tipo de estudo:
Guia de Prática Clínica
Limite:
Humanos
Idioma:
Inglês
Revista:
Rev. bras. hematol. hemoter
Assunto da revista:
Hematologia
Ano de publicação:
2012
Tipo de documento:
Artigo
País de afiliação:
Brasil
Instituição/País de afiliação:
CordCell Centro de Terapia Celular/BR
/
Faculdade de Medicina da Universidade de São Paulo/BR
/
Hemocentro São Lucas/BR
/
Instituto de Ensino e Pesquisa São Lucas/BR
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