Drug safety evaluation

Currently, Shou Ning Biotech has the capability to efficiently produce a substantial quantity of high-quality disease-specific and normal population induced pluripotent stem cells (iPSCs) in vitro. This enables us to offer researchers an unlimited and consistent supply of iPSCs for simulating clinical phase I trials and conducting in vitro toxicity tests for drug evaluation. This approach serves as a partial alternative to the conventional clinical phase I trials conducted directly on human subjects, mitigating the potential harm from drug toxicity during the clinical phase I stage and significantly bolstering the protection of subjects' rights.

Application Examples

(1) In 2013, Guo Liang and colleagues from the Frederick National Cancer Research Laboratory in the United States published a groundbreaking article in Toxicological Sciences. Their study revealed that iPSC-derived cardiomyocytes closely resemble real human cardiomyocytes, surpassing primary cardiomyocytes in authenticity. Furthermore, they refined the cardiac toxicity testing model based on iPSC-derived cardiomyocytes, paving the way for novel applications of iPSCs in drug toxicity assessments.

Reference: Guo, L., Coyle, L., et al. (2013). Refining the human iPSC-cardiomyocyte arrhythmic risk assessment model. Toxicological Sciences An Official Journal of the Society of Toxicology, 136(2), 581.

(2) In 2016, Joseph Wu's research team at Stanford University School of Medicine shared their findings in the prestigious journal Cell Stem Cell. They demonstrated that cardiomyocytes crafted from human-derived iPSCs faithfully retain the unique gene expression patterns of individual patients, particularly those linked to metabolism and stress response. Consequently, these iPSC-derived cardiomyocytes offer a more precise in vitro evaluation of potential cardiac toxicity for each patient. Leveraging this approach, tailored and precise therapies can be developed for individual patients, ensuring optimal treatment efficacy and maximal patient safety.

Reference: Matsa, E., Burridge, P. W., et al. (2016). Transcriptome profiling of patient-specific human ipsc-cardiomyocytes predicts individual drug safety and efficacy responses in vitro. Cell Stem Cell, 19(3), 311-325.