Department of Biomedical Engineering, University of Minnesota, Minneapolis, Minnesota, USA.
Department of Mechanical Engineering, University of Minnesota, Minneapolis, Minnesota, USA.
Cytotherapy. 2021 Apr;23(4):285-292. doi: 10.1016/j.jcyt.2020.12.008. Epub 2021 Jan 30.
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.
Variations between the facilities were identified with product thawing location and cell therapy lab location being the most important factors in time from thaw to infusion.
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.
细胞疗法是治疗多种疾病的一种新兴治疗选择，特别是嵌合抗原受体 T 细胞疗法取得成功之后。截至 2020 年 12 月，已有 18 种 FDA 批准的细胞治疗产品，且临床试验数量不断增加，AABB 和 FACT 等专业组织已经为细胞治疗生命周期的大多数方面制定了标准；但是，在输注当天，关于细胞疗法的标准协议有限。
在美国的三个学术医疗中心观察输注情况，并根据设施布局、产品验证流程、冷冻袋设计、时间限制以及电子病历的使用等因素，对工作流程进行分析和比较。
确定了各医疗机构之间的差异，产品解冻位置和细胞治疗实验室位置是从解冻到输注的时间的最重要因素。
基于此分析，确定了使输注工作流程标准化和简化的机会，这可能有助于在更广泛的医院范围内采用新的和现有的细胞疗法。
