UnicoCell Biomed Co., Ltd. ("UnicoCell", stock code: 6794), a company dedicated to development of innovative stem cell therapies, announced another significant advancement in its research achievements. The comparative study analyzing clinical data and real-world treatment outcomes of ELIXCYTE®-CKD, a chronic kidney disease investigational new drug that has completed Phase I/II clinical trials, has been published in the international journal Clinical and Translational Science. The study demonstrates that UnicoCell's stem cell therapy can significantly delay disease progression in patients with advanced chronic kidney disease (CKD).
This study utilized databases from Shuang Ho Hospital and Taipei Medical University Hospital. From 24,687 medical records, 170 patients who received standard-of-care (SOC) treatment for CKD were identified and match with 34 patients who participated in UnicoCell’s clinical trial for comparative analysis. The results showed that only patients in the SOC treatment group exhibited a mean annual decline in kidney function, as measured by estimated glomerular filtration rate (eGFR), of 18.37%, as illustrated in the corresponding figure. In contrast, patients treated with ELIXCYTE®, a stem cell therapy, showed a substantially smaller mean annual in eGFR of 3.97%. The difference between the two groups reached statistical significance (p<0.05).
Notably, in the dosage group that demonstrated the best kidney function stability during the clinical trial, patients showed a 3.14% increase in eGFR after the one-year of follow-up. For an irreversible condition such as CKD, this result may offer a potential new treatment option to patients with advanced kidney disease.
UnicoCell's clinical program for the treatment of CKD has successfully completed the close-out review of its Phase I/II clinical trial and, in March 2025, received Fast Track designation from U.S. Food and Drug Administration (FDA) , highlighting the FDA's recognition of the innovative potential of ELIXCYTE®-CKD therapy. According to statistics from Taiwan's Ministry of Health and Welfare, Taiwan has the highest dialysis prevalence rate in the world, indicating a substantial medical needs in the CKD market. UnicoCell will continue to advance subsequent clinical trials toward its goal of bringing this innovative therapy to market.
The research paper has been published in Clinical and Translational Science. The full text is available at: https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.70415
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com