Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells

There are only two ways for a patient to gain access to treatment with an experimental product, such as CAR-T cells: participate in a clinical trial or receive a product in a compassionate basis. In the first case, the main beneficiary is society itself, which may in turn obtain a new treatment para...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autor principal:	Gil Cunha De Santis
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Compassionate use Clinical trial CAR T-cell therapy Cell therapy Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/53365929664a408387f719f8f40220a6
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:53365929664a408387f719f8f40220a6
record_format	dspace
spelling	oai:doaj.org-article:53365929664a408387f719f8f40220a62021-11-18T04:51:05ZAssociação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells2531-137910.1016/j.htct.2021.09.009https://doaj.org/article/53365929664a408387f719f8f40220a62021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2531137921001450https://doaj.org/toc/2531-1379There are only two ways for a patient to gain access to treatment with an experimental product, such as CAR-T cells: participate in a clinical trial or receive a product in a compassionate basis. In the first case, the main beneficiary is society itself, which may in turn obtain a new treatment paradigm for a specific disease. In the second case, the use of a medicinal product has the objective of care in benefit of patients in grave clinical condition, for which no approved medicinal products exist, or for which all the possibilities for benefit from standard therapies have been exhausted. The CAR-T cell therapy may be included in one or the other types of access. The compassionate use is not a specific type of clinical research and should therefore not have its use appreciated by a research ethics committee, but rather by the medical ethics committee at the institution where the treatment will take place and by the regulatory agency.Gil Cunha De SantisElsevierarticleCompassionate useClinical trialCAR T-cell therapyCell therapyDiseases of the blood and blood-forming organsRC633-647.5ENHematology, Transfusion and Cell Therapy, Vol 43, Iss , Pp S64-S67 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Compassionate use Clinical trial CAR T-cell therapy Cell therapy Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	Compassionate use Clinical trial CAR T-cell therapy Cell therapy Diseases of the blood and blood-forming organs RC633-647.5 Gil Cunha De Santis Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells
description	There are only two ways for a patient to gain access to treatment with an experimental product, such as CAR-T cells: participate in a clinical trial or receive a product in a compassionate basis. In the first case, the main beneficiary is society itself, which may in turn obtain a new treatment paradigm for a specific disease. In the second case, the use of a medicinal product has the objective of care in benefit of patients in grave clinical condition, for which no approved medicinal products exist, or for which all the possibilities for benefit from standard therapies have been exhausted. The CAR-T cell therapy may be included in one or the other types of access. The compassionate use is not a specific type of clinical research and should therefore not have its use appreciated by a research ethics committee, but rather by the medical ethics committee at the institution where the treatment will take place and by the regulatory agency.
format	article
author	Gil Cunha De Santis
author_facet	Gil Cunha De Santis
author_sort	Gil Cunha De Santis
title	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells
title_short	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells
title_full	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells
title_fullStr	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells
title_full_unstemmed	Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells
title_sort	associação brasileira de hematologia, hemoterapia e terapia celular consensus on genetically modified cells. special article: compassionate use and clinical trial on car-t cells
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/53365929664a408387f719f8f40220a6
work_keys_str_mv	AT gilcunhadesantis associacaobrasileiradehematologiahemoterapiaeterapiacelularconsensusongeneticallymodifiedcellsspecialarticlecompassionateuseandclinicaltrialoncartcells
_version_	1718424972283609088

Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells

Ejemplares similares