UnicoCell Biomed Co., Ltd. (“UnicoCell”, stock code: 6794), a company dedicated to the development of stem cell therapies, announced new progress in its CKD (chronic kidney disease) program. The results of the Phase I/II clinical study of ELIXCYTE®-CKD have been published in the renowned journal, Stem Cells Translational Medicine. The study results demonstrated that the potential of stem cell therapy to slow the progression of CKD while exhibiting favorable safety and tolerability profiles. The Phase I/II clinical trial was conducted by Taipei Medical University-Shuang Ho Hospital, Linkou Chang Gung Memorial Hospital, and Taichung Veterans General Hospital. A total of 39 patients with CKD stages 3b to 4, representing a population with significantly impaired renal function, were enrolled.
Participants received different doses of ELIXCYTE®-CKD and were followed for 48 weeks to evaluate changes in renal function. Evaluation of renal function using eGFR (estimated glomerular filtration rate) showed that approximately 90% (88.24%) of participants maintained stable renal function or experienced improvement. Overall, ELIXCYTE®-CKD was well tolerated across all dose groups. Notably, the low-dose group showed the most consistent outcomes, with more than 70% of patients maintaining stable kidney function and a low incidence of adverse events, providing important data to support dose selection for the subsequent Phase III clinical trial.
ELIXCYTE®-CKD has been granted Fast Track designation by the U.S. FDA (Food and Drug Administration) previously, which is highlighting the potential in the unmet medical needs of chronic kidney disease, and this facilitates more frequent interactions with the FDA during the development period.
Based on the accumulated safety and preliminary efficacy data from the Phase I/II study, UnicoCell submitted an IND (Investigational New Drug) application for a Phase III clinical trial of ELIXCYTE®-CKD to the U.S. FDA in December 2025. The Company will continue to advance its clinical development programs in accordance with rigorous scientific and regulatory standards, while approaching regulatory approval and commercialization.
The full research article has been published in Stem Cells Translational Medicine and is available at: https://academic.oup.com/stcltm/article/15/1/szaf076/8430202
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com