扩大商业细胞疗法的覆盖范围需要在医疗中心进行变革
David F Stroncek1, Nan Zhang2, Jiaqiang Ren2
1The Center for Cellular Engineering, Department of Transfusion Medicine, NIH Clinical Center, 10 Center Drive - MSC -1184, Building 10, Room 3C720, Bethesda, MD, 20892-1184, USA. dstroncek@cc.nih.gov.
Journal of translational medicine
|February 19, 2024
概括
医疗中心需要建立细胞疗法收集,存储和管理的基础设施,以支持对癌症和遗传疾病治疗的日益增长的需求. 建立一个国家网络可以将这些关键过程标准化.
科学领域:
- 细胞疗法制造和临床应用.
- 生物技术和生物制药生产.
- 血液学和瘤学治疗方式.
背景情况:
- 细胞疗法对于治疗癌症,免疫缺陷和血红蛋白病变至关重要.
- 制造业正在从学术中心转移到集中设施.
- 患者衍生细胞是这些疗法的关键起始材料.
研究的目的:
- 突出医疗中心发展细胞治疗处理基础设施的需要.
- 识别广泛实施细胞治疗的障碍和促进因素.
- 建议建立一个国家协调中心,用于标准化细胞治疗物流.
主要方法:
- 分析当前的细胞疗法制造和临床管理实践.
- 在医疗中心确定基本基础设施需求 (收集,冷保存,测试,运输,接收,储存,输注).
- 讨论包括冷保存和解程序在内的后勤挑战.
主要成果:
- 医疗中心需要为细胞治疗服务开发大量的基础设施.
- 输血服务非常适合管理细胞治疗物流.
- 提供者流程的变化构成了实施的障碍.
结论:
- 细胞疗法的广泛采用需要医疗中心的强大基础设施.
- 一个国家协调中心和非中心网络可以促进标准化和效率.
- 收集,处理和管理的标准化协议对于最大限度地发挥细胞治疗潜力至关重要.
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