International evaluation study of a highly efficient culture assay for detection of residual human pluripotent stem cells in cell therapies.

IF 2.6 4区医学 Q4 CELL & TISSUE ENGINEERING Regenerative medicine Pub Date : 2023-03-01 Epub Date: 2023-02-27 DOI:10.2217/rme-2022-0207

Takeshi Watanabe, Satoshi Yasuda, Connie L Chen, Louise Delsing, Mick D Fellows, Gabor Foldes, Shinji Kusakawa, Lucilia Pereira Mouriès, Yoji Sato

引用次数: 0

Abstract

Aim & methods: The Health and Environmental Sciences Institute Cell Therapy-TRAcking, Circulation & Safety Technical Committee launched an international, multisite study to evaluate the sensitivity and reproducibility of the highly efficient culture (HEC) assay, an in vitro assay to detect residual undifferentiated human pluripotent stem cells (hPSCs) in cell therapy products. Results: All facilities detected colonies of human induced pluripotent stem cells (hiPSCs) when five hiPSCs were spiked into 1 million hiPSC-derived cardiomyocytes. Spiking with a trace amount of hiPSCs revealed that repeatability accounts for the majority of reproducibility while the true positive rate was high. Conclusion: The results indicate that the HEC assay is highly sensitive and robust and can be generally applicable for tumorigenicity evaluation of hPSC-derived cell therapy products.

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用于检测细胞疗法中残留的人类多能干细胞的高效培养测定的国际评估研究。

目的与方法：健康与环境科学研究所细胞疗法--检测、流通与安全技术委员会发起了一项国际多点研究，以评估高效培养（HEC）检测法的灵敏度和可重复性，该检测法是一种体外检测法，用于检测细胞疗法产品中残留的未分化人类多能干细胞（hPSC）。结果在 100 万个 hiPSC 衍生心肌细胞中添加 5 个 hiPSC 时，所有设备都能检测到人类诱导多能干细胞（hiPSC）菌落。用微量的 hiPSCs 加标显示，可重复性占可重复性的大部分，而真阳性率很高。结论结果表明，HEC 检测法灵敏度高、稳健，可普遍适用于 hPSC 衍生细胞治疗产品的致瘤性评估。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Regenerative medicine 医学-工程：生物医学

CiteScore

4.20

自引率

3.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function*. Since 2006, Regenerative Medicine has been at the forefront of publishing the very best papers and reviews covering the entire regenerative medicine sector. The journal focusses on the entire spectrum of approaches to regenerative medicine, including small molecule drugs, biologics, biomaterials and tissue engineering, and cell and gene therapies – it’s all about regeneration and not a specific platform technology. The journal’s scope encompasses all aspects of the sector ranging from discovery research, through to clinical development, through to commercialization. Regenerative Medicine uniquely supports this important area of biomedical science and healthcare by providing a peer-reviewed journal totally committed to publishing the very best regenerative medicine research, clinical translation and commercialization. Regenerative Medicine provides a specialist forum to address the important challenges and advances in regenerative medicine, delivering this essential information in concise, clear and attractive article formats – vital to a rapidly growing, multidisciplinary and increasingly time-constrained community. Despite substantial developments in our knowledge and understanding of regeneration, the field is still in its infancy. However, progress is accelerating. The next few decades will see the discovery and development of transformative therapies for patients, and in some cases, even cures. Regenerative Medicine will continue to provide a critical overview of these advances as they progress, undergo clinical trials, and eventually become mainstream medicine.