Measurement of pluripotent stem cell contamination in cell therapy products

Sistemic是一家专注于为细胞治疗研究、开发和制造市场中未满足需求的领域提供创新的基于microrna的工具的公司。细胞疗法被视为治疗的未来，预计将具有巨大潜力，彻底改变糖尿病和心肌梗死等一系列慢性疾病的医疗保健能力。细胞治疗越来越多地使用多能干细胞（PSCs）来产生衍生的细胞治疗产品。然而，聚能干细胞可以形成肿瘤，这是一个安全问题，需要证明污染聚能干细胞的水平。目前还没有一种简单的确定的方法来评估污染。我们已经开发了一个原型产品，基于使用生物标志物来检测衍生细胞治疗产品中的污染psc。Innovate UK将通过与LGC合作提供的创新和先进的测量和分析技术来支持Sistemic。该项目的成果将促进psc衍生细胞治疗产品的安全临床进展，使其更快地成为临床产品。这将使患者在临床试验开发阶段更快地获得这些新疗法，并最终成功推出临床产品，从而改善生活质量。

Sistemic Ltd is a company whose primary business is focused on providing innovative microRNA-based tools for areas of unmet need within cell therapy research, development and manufacturing markets. Cell therapies are seen as the future of treatment and are expected to have great potential, revolutionising medical care capabilities in a range of chronic diseases, such as diabetes and myocardial infarction. Cell therapies are increasingly using pluripotent stem cells (PSCs) to generate derived cell therapy products. However, PSCs can form tumours, which is a safety issue requiring the need to demonstrate the level of contaminating PSCs. Currently there is no simple established way to assess contamination. We have developed a prototype product based around using biomarkers to detect contaminating PSCs in a derived cell therapy product. Innovate UK will support Sistemic through access to innovative and advanced measurement and analytical technologies offered by a partnership with LGC. The outcome of this project will facilitate the safe clinical progress of PSC-derived cell therapy products to bring them to a clinical product more quickly. This will in turn result in patients getting quicker access to these novel therapies during clinical trial development phases, and ultimately, to a successfully launched clinical product and therefore improvements in quality of life.