GXHPC1® demonstrated favorable safety and efficacy in its Phase I human clinical trial. No safety concerns were observed during follow-up period, and patients with liver cirrhosis showed a tendency of improvements for liver function, METAVIR score, Child–Pugh score, MELD score, and quality of life.
Huang, K. C., Chuang, M. H., Lin, Z. S., Lin, Y. C., Chen, C. H., Chang, C. L., Huang, P. C., Syu, W. S., Chiou, T. W., Hong, Z. H., Tsai, Y. C., Harn, H. J., Lin, P. C., & Lin, S. Z. (2019). Transplantation with GXHPC1 for Liver Cirrhosis: Phase 1 Trial. Cell transplantation, 28(1_suppl), 100S–111S.
Human bone marrow-derived mesenchymal stem cells (hBMMSCs) significantly reduced liver fibrosis and promoted tissue recovery in a liver fibrosis animal model via portal vein injection, indicating the therapeutic potential of MSCs for treating liver cirrhosis.
Chang, Y. J., Liu, J. W., Lin, P. C., Sun, L. Y., Peng, C. W., Luo, G. H., Chen, T. M., Lee, R. P., Lin, S. Z., Harn, H. J., & Chiou, T. W. (2009). Mesenchymal stem cells facilitate recovery from chemically induced liver damage and decrease liver fibrosis. Life sciences, 85(13-14), 517–525.
Leveraging GWOXI’s proprietary cell preparation process, human adipose-derived stem cells (hADSCs) were isolated and expanded in culture to achieve 100 million cells (approximately 1,000-fold expansion) within four passages. The cultured hADSCs were rigorously characterized for morphology, chromosomal stability, surface marker expression, and differentiation capacity to ensure consistent quality. Furthermore, tumorigenic potential and therapeutic efficacy were evaluated, confirming the safety and suitability of cultured hADSCs for clinical trials targeting liver cirrhosis.
Lin, Y. C., Harn, H. J., Lin, P. C., Chuang, M. H., Chen, C. H., Lin, S. Z., & Chiou, T. W. (2017). Commercial Production of Autologous Stem Cells and Their Therapeutic Potential for Liver Cirrhosis. Cell transplantation, 26(3), 449–460.
In this study proposal, we investigated the immune-privileged properties of human adipose-derived stem cells (hADSCs) and their effectiveness demonstrated in several studies, indicating strong therapeutic potential for clinical application. Therefore, we propose that hADSCs could represent a promising therapeutic approach for the treatment of liver cirrhosis in clinical trials.
Lin, P. C., Chiou, T. W., Lin, Z. S., Huang, K. C., Lin, Y. C., Huang, P. C., Syu, W. S., Harn, H. J., & Lin, S. Z. (2015). A proposed novel stem cell therapy protocol for liver cirrhosis. Cell transplantation, 24(3), 533–540.
In a rat liver injury model, adipose-derived mesenchymal stem cells (ADSCs) significantly reduced liver fibrosis and promoted tissue recovery within just one day. The number of transplanted stem cells correlated positively with the degree of fibrosis reduction, suggesting that ADSCs could be considered a promising therapeutic option for the treatment of liver cirrhosis.
Harn, H. J., Lin, S. Z., Hung, S. H., Subeq, Y. M., Li, Y. S., Syu, W. S., Ding, D. C., Lee, R. P., Hsieh, D. K., Lin, P. C., & Chiou, T. W. (2012). Adipose-derived stem cells can abrogate chemical-induced liver fibrosis and facilitate recovery of liver function. Cell transplantation, 21(12), 2753–2764.