2023.3.3 Unicocell Biomed Knee Osteoarthritis Treatment Receives FDA approval for Phase III Clinical Trial



On March 3rd, 2023, Unicocell Biomed Co., Ltd. (hereinafter referred to as Unicocell Biomed) had been approved by U.S. Food and Drug Administration (FDA) to conduct the Phase III clinical trial using human allogeneic adipose-derived mesenchymal stem cell (allogeneic hADSC), ELIXCYTE®, to treat patients with knee osteoarthritis.

Following the approval from the Ministry of Health and Welfare in Taiwan to conduct Phase III clinical trials for ELIXCYTE®, a novel drug developed by Unicocell Biomed using human allogeneic adipose-derived mesenchymal stem cells has received further good news today. The application for Phase III clinical trials with the same indication has been approved by the U.S. Food and Drug Administration (FDA). Additionally, previous clinical trials for the treatment of chronic kidney disease, which included Phase I/II trials and concluded patient enrollment, have also been approved in both the United States and Taiwan. These achievements serve as a testament to the research and clinical capabilities of Unicocell Biomed, gaining recognition both domestically and abroad. 

Regenerative medicine offers new treatment possibilities for diseases caused by irreversible damage to organs or tissues. Unicocell Biomed research and development team has been working in stem cell drug development and applications for more than a decade to provide patients with degenerative or irreversible diseases with another opportunity to pursue a better quality of life and dignity. Due to the regenerative, differentiating, and repairing potential of stem cell, it is indeed an eagerly anticipated new therapy in the field of regenerative medicine for the large population suffering from degenerative joint disease. In addition, ELIXCYTE® received the first place Gold Award in the drug category at the national "Drug Technology Research and Development Awards" jointly held by Taiwan's Ministry of Health and Welfare and the Ministry of Economic Affairs in 2021, making it the only cell drug to receive this recognition. Furthermore, ELIXCYTE® has obtained the Drug Master File (DMF) registration application approval from the FDA in 2022, reflecting Unicocell Biomed’s stringent requirements for drug safety and quality. Unicocell Biomed is also exploring clinical development for retinal degenerative diseases and chronic difficult wounds, making it a leader in development of allogeneic adipose-derived mesenchymal stem cell drugs in Taiwan.

In addition, Unicocell Biomed also collaborates with renown medical centers in the treatment of degenerative joint diseases and chronic difficult wounds using autologous cell therapy under RASMET. Currently, hospitals that have implemented the autologous cell therapy for chronic difficult wounds include Shin Kong Wu-Ho-Su Memorial Hospital and Cathay General Hospital; and Linkou Chang Gung Memorial Hospital, Shuang Ho Hospital, Tri-Service General Hospital, Jingmei Hospital, and Kaohsiung Chang Gung Memorial Hospital for degenerative joint diseases. All these hospitals can immediately provide patients with a breakthrough and promising treatment approach for degenerative joint diseases.


Contact: Terry Lee

Phone: 886-2-27922699

Mail: info@unicocell.com