Measurement of pluripotent stem cell contamination in cell therapy products

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.