Comparative analysis of cell therapy infusion workflows at clinical sites.
Comparative analysis of cell therapy infusion workflows at clinical sites.
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DOI：
10.1016/j.jcyt.2020.12.008
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发表时间：
2021-04
期刊：
影响因子：
4.5
通讯作者：
Hubel, Allison
中科院分区：
文献类型：
--
作者：
Joules, Adam;Connors, Julianne;Johnson, Rachel;Van Orsow, Elizabeth A.;McKenna, David H.;Nikiforow, Sarah;Ritz, Jerome;Gee, Adrian;Hubel, Allison
细胞疗法是多种疾病的新兴治疗选择，特别是随着嵌合抗原受体 T 细胞疗法的成功。截至 2020 年 12 月，已有 18 种 FDA 批准的细胞治疗产品，并且越来越多的细胞治疗产品进入临床试验，AABB 和 FACT 等专业组织为细胞治疗生命周期的大多数方面制定了完善的标准；然而，关于输注当天的标准化方案有限。在美国三个学术医疗中心观察输液情况，并根据设施布局、产品验证流程、冷冻袋设计、时间限制和电子病历使用等因素对工作流程进行分析和比较。基于此分析，确定了标准化和简化输注工作流程的机会，这可能有助于促进在更广泛的医院采用新的和现有的细胞疗法。
Cell therapies are an emerging treatment option for a variety of diseases, especially with the success of chimeric antigen receptor T-cell therapies. With 18 FDA-approved cell therapy products as of December 2020 and a growing number in clinical trials, standards for most aspects of the cell therapy lifecycle are well-established by professional organizations like AABB and FACT; however, there are limited standardized protocols regarding the day-of infusion. Infusions were observed at three academic medical centers in the United States, and the workflows were analyzed and compared based on factors including facility layout, product verification processes, cryobag design, timing restrictions, and use of electronic medical records. Based on this analysis, opportunities were identified for standardization and streamlining the infusion workflow which may help facilitate adoption of new and existing cell therapies at a wider range of hospitals.
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