Use of platelets and human platelet-derived products in advanced therapies
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | Vigilância Sanitária em Debate |
DOI: | 10.22239/2317-269X.01064 |
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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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 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 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 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 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 Teixeira, Marcus Vinicius Telles Takamori, Esther Rieko Menezes, Karla Carias, Rosana Bizon Vieira Borojevic, Radovan 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 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_ |
1822182070505439232 |
dc.identifier.doi.none.fl_str_mv |
10.22239/2317-269X.01064 |