Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing

Detalhes bibliográficos
Autor(a) principal: Horinouchi, Cintia Delai da Silva
Data de Publicação: 2018
Outros Autores: Abud, Ana Paula Ressetti, Paschoal, Ariane Caroline, Kuligosvisk, Crisciele, Reus, Thamile Luciane, Muniz, Bruno Dallagiovanna, Aguiar, Alessandra Melo de
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1076
Resumo: Introduction: The use of stem cells for toxicological evaluations seems to be a promising strategy since it allows a greater prediction of human effects. However, in Brazil, there is no specific legislation regulating the use of stem cells for non-therapeutic purposes, technological development, diagnosis or as an alternative method to animal testing. Objective: To review the literature and to provide an overview of the current situation of the non-therapeutic use of stem cells in Brazil and in the world. Method: A non-systematic bibliographic survey was carried out bringing together scientific articles and legislation. Results: This review brings the current approach of Brazilian legislation regarding the non-therapeutic use of human material and briefly discusses international regulatory approaches that allow the non-therapeutic use of stem cells. On the other hand, the Brazilian legislation for use of blood and blood products is quite broad and mature and could serve as a model for the non-therapeutic use of stem cells or other materials of human origin. Conclusions: The encouragement of the debate by the interested bodies and entities is the first step to initiate the development of specific legislation that could allow the scientific and technological development of Brazil in order to follow the world’s biotechnological advances.
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spelling Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testingPerspectivas e desafios regulatórios no uso de células-tronco em métodos alternativos ao uso de animaisCélulas-troncoBiotecnologiaLegislação SanitáriaRegulamentaçãoMétodos AlternativosStem CellsBiotechnologyHealth LegislationRegulationAlternative MethodsIntroduction: The use of stem cells for toxicological evaluations seems to be a promising strategy since it allows a greater prediction of human effects. However, in Brazil, there is no specific legislation regulating the use of stem cells for non-therapeutic purposes, technological development, diagnosis or as an alternative method to animal testing. Objective: To review the literature and to provide an overview of the current situation of the non-therapeutic use of stem cells in Brazil and in the world. Method: A non-systematic bibliographic survey was carried out bringing together scientific articles and legislation. Results: This review brings the current approach of Brazilian legislation regarding the non-therapeutic use of human material and briefly discusses international regulatory approaches that allow the non-therapeutic use of stem cells. On the other hand, the Brazilian legislation for use of blood and blood products is quite broad and mature and could serve as a model for the non-therapeutic use of stem cells or other materials of human origin. Conclusions: The encouragement of the debate by the interested bodies and entities is the first step to initiate the development of specific legislation that could allow the scientific and technological development of Brazil in order to follow the world’s biotechnological advances.Introdução: Utilizar células-tronco para avaliações toxicológicas parece ser uma estratégia promissora para permitir uma maior predição de efeitos em humanos. Entretanto, no Brasil, não existe legislação específica que regulamente o uso de células-tronco para fins não terapêuticos de desenvolvimento tecnológico, diagnóstico ou como método alternativo ao uso de animais. Objetivo: Revisar a literatura e fundamentar um panorama da situação atual do uso não terapêutico de células-tronco no Brasil e no mundo. Método: Realizado levantamento bibliográfico não sistemático reunindo artigos científicos e legislação. Resultados: Essa revisão traz a abordagem atual da literatura científica e da legislação brasileira e discorre brevemente sobre abordagens regulatórias internacionais no que concerne ao uso não terapêutico de células-tronco. Em contrapartida, a legislação brasileira é bastante abrangente e madura na regulamentação de sangue e hemoderivados e pode servir de modelo para o uso não terapêutico de células-tronco ou outros materiais de origem humana. Conclusões: O incentivo do debate pelos órgãos e entidades interessadas é o primeiro passo para iniciar o desenvolvimento de uma legislação específica que permita o desenvolvimento científico-tecnológico do Brasil de maneira a acompanhar os avanços biotecnológicos mundiais.Instituto Nacional de Controle de Qualidade em Saúde2018-05-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/107610.22239/2317-269X.01076Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 2 (2018): May; 92-105Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 2 (2018): Puede; 92-105Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 2 (2018): Maio; 92-1052317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1076/451https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1076/571Copyright (c) 2018 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessHorinouchi, Cintia Delai da SilvaAbud, Ana Paula RessettiPaschoal, Ariane CarolineKuligosvisk, CriscieleReus, Thamile LucianeMuniz, Bruno DallagiovannaAguiar, Alessandra Melo de2023-06-27T15:10:49Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1076Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:10:49Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
Perspectivas e desafios regulatórios no uso de células-tronco em métodos alternativos ao uso de animais
title Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
spellingShingle Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
Horinouchi, Cintia Delai da Silva
Células-tronco
Biotecnologia
Legislação Sanitária
Regulamentação
Métodos Alternativos
Stem Cells
Biotechnology
Health Legislation
Regulation
Alternative Methods
title_short Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
title_full Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
title_fullStr Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
title_full_unstemmed Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
title_sort Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
author Horinouchi, Cintia Delai da Silva
author_facet Horinouchi, Cintia Delai da Silva
Abud, Ana Paula Ressetti
Paschoal, Ariane Caroline
Kuligosvisk, Crisciele
Reus, Thamile Luciane
Muniz, Bruno Dallagiovanna
Aguiar, Alessandra Melo de
author_role author
author2 Abud, Ana Paula Ressetti
Paschoal, Ariane Caroline
Kuligosvisk, Crisciele
Reus, Thamile Luciane
Muniz, Bruno Dallagiovanna
Aguiar, Alessandra Melo de
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Horinouchi, Cintia Delai da Silva
Abud, Ana Paula Ressetti
Paschoal, Ariane Caroline
Kuligosvisk, Crisciele
Reus, Thamile Luciane
Muniz, Bruno Dallagiovanna
Aguiar, Alessandra Melo de
dc.subject.por.fl_str_mv Células-tronco
Biotecnologia
Legislação Sanitária
Regulamentação
Métodos Alternativos
Stem Cells
Biotechnology
Health Legislation
Regulation
Alternative Methods
topic Células-tronco
Biotecnologia
Legislação Sanitária
Regulamentação
Métodos Alternativos
Stem Cells
Biotechnology
Health Legislation
Regulation
Alternative Methods
description Introduction: The use of stem cells for toxicological evaluations seems to be a promising strategy since it allows a greater prediction of human effects. However, in Brazil, there is no specific legislation regulating the use of stem cells for non-therapeutic purposes, technological development, diagnosis or as an alternative method to animal testing. Objective: To review the literature and to provide an overview of the current situation of the non-therapeutic use of stem cells in Brazil and in the world. Method: A non-systematic bibliographic survey was carried out bringing together scientific articles and legislation. Results: This review brings the current approach of Brazilian legislation regarding the non-therapeutic use of human material and briefly discusses international regulatory approaches that allow the non-therapeutic use of stem cells. On the other hand, the Brazilian legislation for use of blood and blood products is quite broad and mature and could serve as a model for the non-therapeutic use of stem cells or other materials of human origin. Conclusions: The encouragement of the debate by the interested bodies and entities is the first step to initiate the development of specific legislation that could allow the scientific and technological development of Brazil in order to follow the world’s biotechnological advances.
publishDate 2018
dc.date.none.fl_str_mv 2018-05-30
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1076
10.22239/2317-269X.01076
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1076
identifier_str_mv 10.22239/2317-269X.01076
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1076/451
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1076/571
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 2 (2018): May; 92-105
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 2 (2018): Puede; 92-105
Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 2 (2018): Maio; 92-105
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
_version_ 1797042045220552704

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