Use of platelets and human platelet-derived products in advanced therapies

Detalhes bibliográficos
Autor(a) principal: Teixeira, Marcus Vinicius Telles
Data de Publicação: 2018
Outros Autores: Takamori, Esther Rieko, Menezes, Karla, Carias, Rosana Bizon Vieira, Borojevic, Radovan
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/1064
Resumo: Introduction: Platelets have a central role in the tissue response to injury, in hemostasis and clot formation. They also release rapidly and in orchestrated order bioactive molecules, important for angiogenesis and for tissue regeneration. Non-transfusional clinical use of platelet-derived products, such as Platelet Rich Plasma (PRP), is based on their ability to maximize cellular regeneration in lesions that have repair difficulties. Objectives: This review addresses the characteristics and the potential clinical use of platelets and their derivatives and discusses the legislative framework of their use in the Brazilian context. Method: The databases of PubMed, Brazilian Virtual Health Library, electronic pages of Anvisa and the Brazilian Ministry of Health were consulted between September 2017 and January 2018. Results: PRP is a platelet-derived product that cannot be chemically defined, and its proposed clinical uses are not orthologous applications. Conclusions: We can thus consider that the applications of PRP are Advanced Cell Therapies. Therefore, it is mandatory to standardize protocols and establish quality control criteria - such as traceability, efficacy and pharmacovigilance - so that their use can be properly controlled by the competent regulatory organs, guaranteeing safety in their use.
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spelling Use of platelets and human platelet-derived products in advanced therapiesUtilização de plaquetas e de produtos derivados de plaquetas humanas em terapias avançadasPlaquetasPlasma Rico em PlaquetasRegeneraçãoMedicina RegenerativaBlood PlateletPlatelet-Rich PlasmaRegenerationRegenerative MedicineIntroduction: Platelets have a central role in the tissue response to injury, in hemostasis and clot formation. They also release rapidly and in orchestrated order bioactive molecules, important for angiogenesis and for tissue regeneration. Non-transfusional clinical use of platelet-derived products, such as Platelet Rich Plasma (PRP), is based on their ability to maximize cellular regeneration in lesions that have repair difficulties. Objectives: This review addresses the characteristics and the potential clinical use of platelets and their derivatives and discusses the legislative framework of their use in the Brazilian context. Method: The databases of PubMed, Brazilian Virtual Health Library, electronic pages of Anvisa and the Brazilian Ministry of Health were consulted between September 2017 and January 2018. Results: PRP is a platelet-derived product that cannot be chemically defined, and its proposed clinical uses are not orthologous applications. Conclusions: We can thus consider that the applications of PRP are Advanced Cell Therapies. Therefore, it is mandatory to standardize protocols and establish quality control criteria - such as traceability, efficacy and pharmacovigilance - so that their use can be properly controlled by the competent regulatory organs, guaranteeing safety in their use.Introdução: As plaquetas têm um papel central no processo da resposta tecidual à injúria, atuando na hemostasia primária e na coagulação, e liberando de maneira coordenada as moléculas bioativas importantes para a angiogênese e para a regeneração tecidual. O uso clínico não transfusional de produtos derivados de plaquetas, como o Plasma Rico em Plaquetas (PRP), baseia-se na sua habilidade de maximizar o processo de regeneração celular, em lesões com dificuldades de reparo natural. Objetivo: Esta revisão aborda as características e potencialidades do uso clínico de plaquetas e seus derivados e discute seu arcabouço legislativo no contexto brasileiro. Método: Foram consultadas as bases de dados PubMed, Biblioteca Virtual em Saúde, páginas eletrônicas da Anvisa e do ministério da Saúde, entre setembro 2017 e janeiro de 2018. Resultado: O PRP é produto derivado de plaquetas que não pode ser quimicamente definido, e o seu uso clínico aqui discutido não é ortólogo. Conclusão: Dessa maneira, podemos considerar a aplicação do PRP como uma Terapia Celular Avançada, sendo fundamental padronizar protocolos, estabelecer critérios de controle de qualidade (rastreabilidade, eficácia e fármaco-vigilância), tornando seu uso devidamente controlado pelos órgãos competentes, com maior segurança na sua utilização.Instituto Nacional de Controle de Qualidade em Saúde2018-02-28info: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/106410.22239/2317-269X.01064Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 1 (2018): February - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 125-136Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 1 (2018): Febrero - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 125-136Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 1 (2018): Fevereiro - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 125-1362317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1064/436https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1064/568Copyright (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/openAccessTeixeira, Marcus Vinicius TellesTakamori, Esther RiekoMenezes, KarlaCarias, Rosana Bizon VieiraBorojevic, Radovan2023-06-27T15:07:41Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1064Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:07:41Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Use of platelets and human platelet-derived products in advanced therapies
Utilização de plaquetas e de produtos derivados de plaquetas humanas em terapias avançadas
title Use of platelets and human platelet-derived products in advanced therapies
spellingShingle Use of platelets and human platelet-derived products in advanced therapies
Teixeira, Marcus Vinicius Telles
Plaquetas
Plasma Rico em Plaquetas
Regeneração
Medicina Regenerativa
Blood Platelet
Platelet-Rich Plasma
Regeneration
Regenerative Medicine
title_short Use of platelets and human platelet-derived products in advanced therapies
title_full Use of platelets and human platelet-derived products in advanced therapies
title_fullStr Use of platelets and human platelet-derived products in advanced therapies
title_full_unstemmed Use of platelets and human platelet-derived products in advanced therapies
title_sort Use of platelets and human platelet-derived products in advanced therapies
author Teixeira, Marcus Vinicius Telles
author_facet Teixeira, Marcus Vinicius Telles
Takamori, Esther Rieko
Menezes, Karla
Carias, Rosana Bizon Vieira
Borojevic, Radovan
author_role author
author2 Takamori, Esther Rieko
Menezes, Karla
Carias, Rosana Bizon Vieira
Borojevic, Radovan
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Teixeira, Marcus Vinicius Telles
Takamori, Esther Rieko
Menezes, Karla
Carias, Rosana Bizon Vieira
Borojevic, Radovan
dc.subject.por.fl_str_mv Plaquetas
Plasma Rico em Plaquetas
Regeneração
Medicina Regenerativa
Blood Platelet
Platelet-Rich Plasma
Regeneration
Regenerative Medicine
topic Plaquetas
Plasma Rico em Plaquetas
Regeneração
Medicina Regenerativa
Blood Platelet
Platelet-Rich Plasma
Regeneration
Regenerative Medicine
description Introduction: Platelets have a central role in the tissue response to injury, in hemostasis and clot formation. They also release rapidly and in orchestrated order bioactive molecules, important for angiogenesis and for tissue regeneration. Non-transfusional clinical use of platelet-derived products, such as Platelet Rich Plasma (PRP), is based on their ability to maximize cellular regeneration in lesions that have repair difficulties. Objectives: This review addresses the characteristics and the potential clinical use of platelets and their derivatives and discusses the legislative framework of their use in the Brazilian context. Method: The databases of PubMed, Brazilian Virtual Health Library, electronic pages of Anvisa and the Brazilian Ministry of Health were consulted between September 2017 and January 2018. Results: PRP is a platelet-derived product that cannot be chemically defined, and its proposed clinical uses are not orthologous applications. Conclusions: We can thus consider that the applications of PRP are Advanced Cell Therapies. Therefore, it is mandatory to standardize protocols and establish quality control criteria - such as traceability, efficacy and pharmacovigilance - so that their use can be properly controlled by the competent regulatory organs, guaranteeing safety in their use.
publishDate 2018
dc.date.none.fl_str_mv 2018-02-28
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/1064
10.22239/2317-269X.01064
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1064
identifier_str_mv 10.22239/2317-269X.01064
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/1064/436
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1064/568
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. 1 (2018): February - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 125-136
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 1 (2018): Febrero - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 125-136
Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 1 (2018): Fevereiro - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 125-136
2317-269X
reponame:Vigilância Sanitária em Debate
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reponame_str Vigilância Sanitária em Debate
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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
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