Unicocell Biomed Co., Ltd. (referred to as Unicocell Biomed) has successfully enrolled the first participant in the phase III clinical trial for the treatment of knee osteoarthritis on the 10th of July, 2023, at Linkou Chang Gung Memorial Hospital.
Unicocell Biomed phase III clinical trial for the treatment of knee osteoarthritis, using its novel cell drug ELIXCYTE®, derived from human allogeneic adipose-derived mesenchymal stem cells, received approval from the Taiwan Food and Drug Administration (TFDA) and the U.S. Food and Drug Administration (FDA) in February and Marchin 2023, respectively. The trial aims to recruit patients with unilateral or bilateral knee joint degeneration classified as grade II-III. The results of the phase I/II clinical trial for this clinical study were published in Stem Cell Research & Therapy on October 30, 2021, attracting significant attention due to its promising efficacy. Stem cells possess the potential for regeneration, differentiation, and repair, making them a highly anticipated regenerative medicine approach for the large population suffering from degenerative joint diseases. ELIXCYTE®, the investigational drug used in this clinical trial, was received the first place Gold Award in the drug category at the national "Drug Technology Research and Development Awards" jointly organized by the Taiwan Ministry of Health and Welfare and the Ministry of Economic Affairs in 2021. It is currently the only cell drug to receive this prestigious recognition. Furthermore, UnicoCellBiomed has obtained the Drug Master File (DMF) registration application approval from the FDA for its allogeneic cell bank in 2022, reflecting Unicocell Biomed’s stringent requirements for drug safety and quality.
Unicocell Biomed phase I/II clinical trial for the treatment of chronic kidney disease, completed the last participant enrollment in July 2022. Following a one-year follow-up observation period, unblinding analysis is scheduled to begin in July 2023. Subsequently, the next phase of the clinical trial will be planned based on the unblinding results. The safety results of the phase I of clinical trial for chronic kidney disease treatment were already published in the Journal of Cellular and Molecular Medicine on April 12, 2022. Unicocell Biomed aims to provide another opportunity for patients with degenerative or irreversible diseases to pursue a better quality of life and dignity.
Additionally, Unicocell Biomed collaborates with renown medical centers for the treatment of degenerative joint diseases and chronic difficult wounds under RASMET. The hospitals that have obtained approval for the use of autologous cell therapy in 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. These hospitals can immediately provide degenerative joint disease patients with a breakthrough and promising treatment option.
Contact: Terry Lee