From laboratory to clinic: Bridging regulatory and manufacturing gaps in stem cell-based therapies

Figure 6 Comparison of safety risks and manufacturing requirements for induced pluripotent stem cell-derived products vs mesenchymal stem cell-based therapies. This figure highlights fundamental differences in biosafety profiles between induced pluripotent stem cell derivatives and mesenchymal stem cells. Induced pluripotent stem cell-derived cell populations may retain undifferentiated cells, accumulate genomic abnormalities, or exhibit heterogeneous differentiation states, all of which heighten tumorigenic risk. In contrast, mesenchymal stem cells demonstrate a substantially lower propensity for malignant transformation and benefit from established quality frameworks, including routine genomic monitoring and compliance with good manufacturing practice, supporting their more predictable and safer use in therapeutic production. iPSC: Induced pluripotent stem cell; MSC: Mesenchymal stem cell.