Detection of residual pluripotent stem cells in cell therapy products utilizing droplet digital PCR: an international multisite evaluation study

The HESI CT-TRACS Committee is pleased to announce the release of its latest publication titled “Detection of Residual Pluripotent Stem Cells in Cell Therapy Products Utilizing Droplet Digital PCR: An International Multisite Evaluation Study” in Stem Cells Translational Medicine.

This study addresses a critical safety concern in regenerative medicine—the presence of residual undifferentiated pluripotent stem cells (PSCs) in cell therapy products (CTPs), which poses a risk of tumor formation. The research highlights the successful application of droplet digital PCR (ddPCR) as a highly sensitive and robust method for detecting these impurities.

Key takeaways from the study include:

• The ddPCR method showed exceptional sensitivity, detecting as low as 0.0003% of residual iPSCs in CTPs.
• The study confirmed the reliability and reproducibility of ddPCR across multiple international laboratories.
• This approach is expected to significantly enhance the safety and quality control of PSC-derived therapies, ensuring better outcomes in clinical applications.

This publication marks a significant advancement in the field of regenerative medicine, providing a standardized method that can be widely adopted to improve the safety of cell-based therapies.

Read the full paper at the link below:
Detection of residual pluripotent stem cells in cell therapy products utilizing droplet digital PCR: an international multisite evaluation study. Yasuda et. al., (2024). STEM CELLS Translational Medicine. https://doi.org/10.1093/stcltm/szae058