2023.2.8 Approval Granted for Unicocell Biomed to Initiate Phase III Clinical Trial for Knee Osteoarthritis Treatment



On February 8, 2023, Unicocell Biomed Co., Ltd. (referred to as Unicocell Biomed) received a letter from the Taiwan Ministry of Health and Welfare, notifying them of the approval to conduct the Phase III clinical trial for the treatment of knee osteoarthritis. Unicocell Biomed has completed the Phase I/II clinical trials for the treatment of knee osteoarthritis using its novel drug ELIXCYTE®, which utilizes human allogeneic adipose-derived mesenchymal stem cells. Clinical findings demonstrate that the injection of ELIXCYTE® provides earlier relief of pain and stiffness in patients compared to the control group treated with hyaluronic acid. Moreover, ELIXCYTE® exhibits superior durability and efficacy in its therapeutic effects. The Phase I/II clinical results were published in the international journal Stem Cell Research & Therapy on October 30, 2021. Now, with the approval from the Ministry of Health and Welfare to proceed with the Phase III clinical trial is another milestone for Unicocell Biomed in the field of regenerative medicine, as stem cells possess the potential for regeneration, differentiation, and repair, making them a promising therapy for the large population suffering from degenerative joint diseases.

Regenerative medicine offers new possibilities for diseases caused by irreversible organ or tissue damage. Unicocell Biomed’s research and development team has been engaged in the research and application of stem cell new drugs for over a decade, aiming to provide alternative opportunity for patients with degenerative or irreversible diseases to pursue a better quality of life and dignity. ELIXCYTE® is also the first stem cell-based clinical trial in Taiwan that has been approved for execution by both the U.S. FDA and the Taiwan FDA (TFDA) for the treatment of chronic kidney disease. The Phase I/II trial for this indication has been completed, and the unblinding is expected to occur in 2023. In 2021, ELIXCYTE® received the first-place Gold Award in the drug category at the national “Drug Technology Research and Development Award”, co-sponsored by the Taiwan Ministry of Health and Welfare and the Ministry of Economic Affairs, becoming the only cell-based new drug to be recognized with a Gold Award. This further proven Unicocell Biomed’s solid research and development capabilities and achievements. Unicocell Biomed is also exploring clinical development for retinal degenerative diseases and chronic difficult wounds, pioneering allogeneic adipose-derived mesenchymal stem cell drug development in Taiwan.

In addition, Unicocell Biomed also collaborates with renown medical centers in Taiwan for the treatment of degenerative joint diseases and chronic difficult wounds under the “RASMET” (The Regulation Governing the Application of Specific Medical Examination Technique and Medical Device). Our hospital partners including Shin Kong Wu Huo-Shih Memorial Hospital and Cathay General Hospital for chronic difficult wounds; and Linkou Chang Gung Memorial Hospital, Tri-Service General Hospital, JingMei Hospital, and Kaohsiung Chang Gung Memorial Hospital for knee osteoarthritis, offering an immediate breakthrough and promising treatment option for patients with degenerative joint disease.


Contact: Terry Lee

Phone: 886-2-27922699

Mail: info@unicocell.com