Unicocell Biomed Co., Ltd. ("Unicocell") is pleased to announce that its allogeneic adipose-derived stem Cells, ELIXCYTE®, for the treatment of chronic kidney disease, has been granted Fast Track Designation by the U.S. Food and Drug Administration (US-FDA). This designation is intended to accelerate the development and review process of innovative therapies for serious diseases with unmet medical needs.
The FDA Fast Track Designation is primarily for serious conditions with unmet medical needs, aiming to accelerate the development and review process for innovative therapies. UnicoCell’s investigational treatment, ELIXCYTE, for chronic kidney disease (CKD) has completed Phase 1/2 clinical trials. Receiving Fast Track designation not only underscores the FDA’s recognition potential of ELIXCYTE® as an innovative therapy for chronic kidney disease but also facilitates its progression into subsequent clinical trials and regulatory approval stages.
At the beginning of 2025, UnicoCell achieved multiple milestones in new drug development. After the approval of PIC/S GMP pilot plant certification by Ministry of Health and Welfare on March 5, the company received Fast Track designation from the US FDA for its investigational treatment, ELIXCYTE®, for CKD, which will further expedite the approval timeline for ELIXCYTE®. Unicocell continues to advance its clinical trials and collaborate closely with global regulatory agencies, striving to provide better treatment options for patients worldwide.
Currently, UnicoCell is conducting clinical trials for globally irreversible diseases, including chronic kidney disease and the phase 3 trial of Knee OA under patient recruitment. UnicoCell is hoping to deliver innovative treatment options to patients.
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com