On August 2nd, the Taiwan Ministry of Health and Welfare approved the Phase 1/2 clinical trial report of allogeneic stem cell therapy for chronic kidney disease completed by UnicoCell Biomed. This trial is the first clinical trial for cell therapy approved by the Taiwan and U.S. FDA. It is also the first trial to use intravenous injection to test safety in human systemic circulation. As such, it has garnered significant attention. UnicoCell Biomed will consult with relevant parties to plan and advance subsequent clinical trials.
The patients of chronic kidney disease are substantially growing in Taiwan and globally. In Taiwan alone, the number of patients exceeded 2 million in 2023, and there are approximately 10,000 new patients for dialysis each year. According to National Health Insurance Administration statistics, the 2022 NHI expenditure for chronic kidney disease reached NT$57.6 billion.
UnicoCell BioMed’s progress in this area is ahead of the domestic and international industries. In addition to proceeding with a Phase 3 clinical trial, the company will apply for accelerated approval under the "Regenerative Medicine Product Act," hoping UnicoCell Biomed will get the first approval for the chronic kidney disease treatment market with cellular therapy.
Furthermore, the Phase 3 clinical trial for knee osteoarthritis treatment is ongoing, with patient recruitment at Linkou Chang Gung Memorial Hospital, National Taiwan University Hospital, and Taipei Veterans General Hospital. UnicoCell Biomed aims to offer regenerative medicine cell therapies as a new hope for patients with degenerative or irreversible diseases striving for better quality and dignity of life.
Contact: Eileen Chen
Phone: 886-2-27922699
Mail: info@unicocell.com