Celsense, Inc, Pittsburgh, Pennsylvania, USA.
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Cytotherapy. 2021 Sep;23(9):757-773. doi: 10.1016/j.jcyt.2021.02.005. Epub 2021 Apr 6.
Cell-based therapies have been making great advances toward clinical reality. Despite the increase in trial activity, few therapies have successfully navigated late-phase clinical trials and received market authorization. One possible explanation for this is that additional tools and technologies to enable their development have only recently become available. To support the safety evaluation of cell therapies, the Health and Environmental Sciences Institute Cell Therapy-Tracking, Circulation and Safety Committee, a multisector collaborative committee, polled the attendees of the 2017 International Society for Cell & Gene Therapy conference in London, UK, to understand the gaps and needs that cell therapy developers have encountered regarding safety evaluations in vivo. The goal of the survey was to collect information to inform stakeholders of areas of interest that can help ensure the safe use of cellular therapeutics in the clinic. This review is a response to the cellular imaging interests of those respondents. The authors offer a brief overview of available technologies and then highlight the areas of interest from the survey by describing how imaging technologies can meet those needs. The areas of interest include imaging of cells over time, sensitivity of imaging modalities, ability to quantify cells, imaging cellular survival and differentiation and safety concerns around adding imaging agents to cellular therapy protocols. The Health and Environmental Sciences Institute Cell Therapy-Tracking, Circulation and Safety Committee believes that the ability to understand therapeutic cell fate is vital for determining and understanding cell therapy efficacy and safety and offers this review to aid in those needs. An aim of this article is to share the available imaging technologies with the cell therapy community to demonstrate how these technologies can accomplish unmet needs throughout the translational process and strengthen the understanding of cellular therapeutics.
基于细胞的疗法在向临床现实迈进方面取得了重大进展。尽管试验活动有所增加，但很少有疗法成功地通过了后期临床试验并获得市场授权。对此的一个可能解释是，能够促进其发展的额外工具和技术最近才变得可用。为了支持细胞疗法的安全性评估，健康与环境科学研究所细胞疗法跟踪、循环与安全委员会（一个多部门合作委员会）对英国伦敦 2017 年国际细胞与基因治疗学会会议的与会者进行了民意调查，以了解细胞疗法开发者在体内安全性评估方面遇到的差距和需求。该调查的目的是收集信息，让利益相关者了解感兴趣的领域，这些领域有助于确保细胞疗法在临床中的安全使用。本综述是对这些受访者细胞成像兴趣的回应。作者简要概述了可用的技术，然后通过描述成像技术如何满足这些需求，突出了调查中的关注领域。关注领域包括随时间对细胞的成像、成像模式的灵敏度、对细胞进行定量的能力、对细胞存活和分化的成像以及在细胞治疗方案中添加成像剂的安全性问题。健康与环境科学研究所细胞疗法跟踪、循环与安全委员会认为，了解治疗性细胞命运对于确定和理解细胞疗法的疗效和安全性至关重要，因此提供了本综述以满足这些需求。本文的目的之一是与细胞治疗社区分享现有的成像技术，展示这些技术如何在整个转化过程中满足未满足的需求，并加强对细胞治疗的理解。
