UnicoCell Biomed Co., Ltd. (hereinafter “UnicoCell,” stock code: 6794) announced that on 22 December, submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (US FDA) for a Phase III clinical trial of its allogeneic adipose-derived mesenchymal stem cell new drug, ELIXCYTE®, for the treatment of chronic kidney disease (CKD).
Chronic kidney disease is one of the most prevalent and rapidly growing challenges of global health. According to statistics, more than 800 million people worldwide are affected by CKD. As renal function progressively deteriorates, patients may ultimately develop end-stage renal disease requiring long-term dialysis, having a significant burden on both patients’ quality of life and healthcare systems.
The Phase I/II clinical trial of ELIXCYTE® for CKD was completed in 2024. The trial results were compared with real-world data from patients with similar disease progression and have been published in the international journal Clinical and Translational Science.
Compared with patients receiving standard-of-care treatment alone, whose estimated glomerular filtration rate (eGFR) declined by an average of 18.37% over one year, patients receiving ELIXCYTE®, particularly those in the dose group showing the best renal function stability, demonstrated a 3% upward trend in eGFR, indicating superior renal function stability. These findings suggest that stem cell therapy holds significant potential clinical benefits in preserving renal function and may offer a promising opportunity to delay disease progression in CKD patients.
In March of this year, ELIXCYTE® for the treatment of CKD was granted Fast Track designation by the US FDA, highlighting the agency’s recognition of ELIXCYTE® as a potentially innovative therapy for this serious disease. The current Phase III clinical trial submission represents a critical step that could lead to a major breakthrough in improving CKD treatment.
This submission marks the first Phase III clinical trial in Taiwan using allogeneic adipose-derived stem cells to treat CKD submitted to the US FDA, representing a breakthrough for Taiwan regenerative medicine on the global stage. UnicoCell will continue to advance the clinical program under rigorous scientific and regulatory standards, leveraging clinical research results to support regulatory approval and commercialization strategies.
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com