Research Tool

Tool for Measuring Cell Purity and Quality Control of Stem Cell-based Products

Application

Cell-based assay for sensitive and specific detection of undifferentiated cells in stem cell-related research and development.

Key Benefits

Nanotechnology-based assay can detect residual undifferentiated cells and characterize cultures that may be tumorigenic.
Technology is potentially more sensitive method compared to current methods.

Market Summary

Human pluripotent stem cells (hPSCs) have emerged as a potentially invaluable resource for cell therapy and regenerative medicine. A major concern is the potential risk for residual undifferentiated stem cells in preparations of hPSC derivatives to multiply and form a tumor upon transplantation. Existing cell-based assays including flow cytometry lack adequate sensitivity (>0.1%) to meet the stringent safety standard for stem cell products, thus requiring the development of a cell-based assay with high sensitivity and specificity.

Technical Summary

Current cell-based assays provide inadequate sensitivity to assess potential risk of tumor formation in hPSC products. Researchers at Emory have developed a nanotechnology-based assay for the detection of residual undifferentiated stem cells. The assay uses surface enhanced Raman scattering nanoparticles (SERS), which are conjugated to antibodies against the pluripotency surface marker (TRA1-60) and modified for improved detection. The TRA1-60-SERS assay is able to detect stem cells in a cell mixture containing 0.01% stem cells. The high sensitivity and specificity of this SERS assay makes it a useful tool for transplantation of hPSC-derived production and characterization of differentiation cultures at various stages for risk of tumor development.

Publication: Han J. et al. Biomaterials. 2016 Oct;105:66-76. doi: 10.1016