CAR-T（CAR-T）细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T（CAR-T）细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
巴西血液学、血液疗法与细胞治疗协会关于基因修饰细胞的共识。特别文章：CAR-T 细胞的同情使用与临床试验
英文原题：Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells.
查看英文原题
Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. Special article: compassionate use and clinical trial on CAR-T cells.
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中文摘要
患者获得实验性产品（如 CAR-T 细胞）治疗只有两种途径：参加临床试验或以同情用药方式接受产品。在第一种情况下，主要受益者是社会本身，社会可能因此获得针对特定疾病的新治疗范式。在第二种情况下，使用药品的目的是为临床状况严重、尚无已批准药品可用、或已穷尽标准疗法所有获益可能的患者提供照护。CAR-T 细胞治疗可归入这两种获取类型中的任一种。同情用药不是一种特定的临床研究类型，因此其使用不应由研究伦理委员会评审，而应由实施治疗的机构的医学伦理委员会和监管机构评审。
展开英文摘要原文
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.
论文信息
- 作者
- De Santis GC
- 单位
- Hemocentro de Ribeirão Preto, Ribeirão Preto, SP, Brazil. Electronic address: gil@hemocentro.fmrp.usp.br.Brazil
- 期刊
- Hematology, transfusion and cell therapy2021 Nov
- 原文标识
- PubMed 34794799 · DOI 10.1016/j.htct.2021.09.009
在 PubMed 查看 → 出版商原文（DOI） 全文 PDF（PMC）· 可下载 治疗专题与资料阅读指南 资料来源与翻译说明 报告译文或资料问题 →