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在澳大利亚建立稳健的 CAR-T 细胞治疗项目:皇家阿尔弗雷德王子医院的经验

英文原题:Establishing a robust chimeric antigen receptor T-cell therapy program in Australia: the Royal Prince Alfred Hospital experience.

查看英文原题

Establishing a robust chimeric antigen receptor T-cell therapy program in Australia: the Royal Prince Alfred Hospital experience.

PubMed 2021/09/11(内容时间) Cytotherapy Q1 · IF 4.5(JCR 2025)

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中文摘要

嵌合抗原受体(CAR)T细胞疗法是一种新近获批的癌症治疗方法,在复发白血病和淋巴瘤患者的治疗中显示出显著疗效。由于提供这种专业服务的复杂性,在医院环境中实施CAR-T 细胞疗法需要周密详细的规划。需要多学科协作和专项经费,以满足临床、科学、后勤和监管方面的要求。Tisagenlecleucel是澳大利亚首个获批的CAR-T 细胞疗法。通过联邦和州政府拨款,该治疗已在专科公立医院向澳大利亚患者提供。Royal Prince Alfred Hospital(RPAH)是澳大利亚历史最悠久的三级转诊公共卫生保健机构之一,于2019年获批提供CAR-T 细胞治疗服务。该院已建立多学科临床项目,涵盖供者细胞的采集和冷冻保存(用于运送至生产方)、CAR-T 细胞疗法的接收、储存和给药以及患者管理。该项目包括一个经治疗用品管理局认证的血细胞分离单位和最先进的细胞处理、冷冻保存和储存设施。该项目的临床专业能力涵盖血液学、肿瘤学、重症监护、药学、神经病学和放射学服务,在管理接受CAR-T 细胞疗法的患者方面具有直接经验。在RPAH引入CAR-T 细胞疗法是一项复杂的工程,得益于现有的基础设施和临床专业能力而得以实现。

展开英文摘要原文

>himeric antigen receptor (CAR) T-cell therapy is a novel approved cancer treatment that has shown remarkable efficacy in the treatment of patients with relapsed leukemia and lymphoma. Implementation of CAR T-cell therapy in a hospital setting requires careful and detailed planning because of the complexities in delivering this specialist service. A multi-disciplinary approach with dedicated funding is required to meet clinical, scientific, logistic and regulatory requirements. Tisagenlecleucel was the first approved CAR T-cell therapy in Australia. The treatment has been made available to Australian patients in specialist public hospitals through federal and state funding. Royal Prince Alfred Hospital (RPAH) is one of Australia's oldest tertiary referral public health care institutions and was approved for the provision of CAR T-cell therapy service in 2019.

A multi-disciplinary clinical program has been established for the collection and cryopreservation of donor cells shipped for manufacturing as well as for the receipt, storage and administration of CAR T-cell therapy and patient management. The program encompasses a Therapeutic Goods Administration-accredited apheresis unit and a state-of-the-art facility for cell processing, cryopreservation and storage.

The program's clinical expertise extends to hematology, oncology, intensive care, pharmacy, neurology and radiology services with direct experience in managing patients receiving CAR T-cell therapies. The introduction of CAR T-cell therapies at RPAH was a complex undertaking facilitated by the existing infrastructure and clinical expertise.

论文信息

作者
Velickovic ZM、Rasko JEJ
第一作者单位
Department of Cell and Molecular Therapies, Royal Prince Alfred Hospital, Sydney, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, Australia.Australia
通讯作者单位
Department of Cell and Molecular Therapies, Royal Prince Alfred Hospital, Sydney, Australia; Gene and Stem Cell Therapy Program, Centenary Institute, Sydney, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, Australia. Electronic address: j.rasko@centenary.org.au.Australia
期刊
Cytotherapy2022 Jan
原文标识
PubMed 34521574 · DOI 10.1016/j.jcyt.2021.06.005