The ability to detect rare human pluripotent stem cells (hPSCs) in differentiated populations is critical for safeguarding the clinical translation of cell therapy, as these undifferentiated cells have the capacity to form teratomas in vivo. The detection of hPSCs must be performed using an approach compatible with traceable manufacturing of therapeutic cell products. Here, we report a novel microfluidic approach, stem cell quantitative cytometry (SCQC), for the quantification of rare hPSCs in hPSC-derived cardiomyocyte (CM) populations. This approach enables the ultrasensitive capture, profiling, and enumeration of trace levels of hPSCs labeled with magnetic nanoparticles in a low-cost, manufacturable microfluidic chip. We deploy SCQC to assess the tumorigenic risk of hPSC-derived CM populations in vivo. In addition, we isolate rare hPSCs from the differentiated populations using SCQC and characterize their pluripotency.

中文翻译：

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超灵敏和快速定量 hPSC 衍生心肌细胞群中罕见的致瘤干细胞。

在分化人群中检测稀有人类多能干细胞 (hPSC) 的能力对于保障细胞疗法的临床转化至关重要，因为这些未分化细胞具有在体内形成畸胎瘤的能力。必须使用与治疗性细胞产品的可追溯制造兼容的方法来检测 hPSC。在这里，我们报告了一种新的微流体方法，即干细胞定量细胞仪 (SCQC)，用于量化 hPSC 衍生的心肌细胞 (CM) 群体中的稀有 hPSC。这种方法能够在低成本、可制造的微流控芯片中超灵敏地捕获、分析和枚举用磁性纳米粒子标记的微量 hPSC。我们部署 SCQC 来评估 hPSC 衍生的 CM 群体在体内的致瘤风险。此外，