UnicoCell Biomed Co., Ltd. (UnicoCell; stock code: 6794) announced that its stem cell therapy ELIXCYTE®-OA has achieved significant research breakthroughs in the treatment of osteoarthritis. In 2025, ELIXCYTE®-OA successfully completed patient enrollment for its Phase III clinical trial. Alongside steady progress in its clinical trials, UnicoCell continues to advance scientific research into the therapeutic mechanisms of stem cell treatments. Recently, in collaboration with its long-term research partner, the team at Linkou Chang Gung Memorial Hospital, UnicoCell achieved major advances in the mechanism of action of stem cell therapy for osteoarthritis. This finding not only strengthens the scientific validation of ELIXCYTE®-OA in treating osteoarthritis but has also been officially published in an international immunopharmacology journal on December 24, 2025, providing compelling evidence for future regulatory approvals and drug licensing.
This study utilized a spontaneous osteoarthritis animal model (STR/ort) that more closely resembles the natural progression of joint degeneration, allowing a more accurate evaluation of ELIXCYTE®-OA’s therapeutic potential and mechanisms of action in osteoarthritis. The results demonstrated that a single treatment of ELIXCYTE®-OA effectively reduced inflammatory responses, cartilage degeneration, and maintained cartilage structural integrity. The study also revealed that early-stage intervention with stem cell therapy yields superior results in joint protection and the reduction of inflammatory responses. Moreover, the study revealed a continuous interaction between ELIXCYTE®-OA and the cartilage after treatment, highlighting its promising potential for long-term effectiveness.
These research findings reinforce the results of ELIXCYTE®-OA's Phase I/II clinical trials, which demonstrated significant pain relief and functional improvement lasting up to one year after a single injection. UnicoCell’s investigational therapy for knee osteoarthritis has been approved by both the U.S. Food and Drug Administration (FDA) and the Taiwan Food and Drug Administration (TFDA) to proceed to Phase III clinical trials, with patient enrollment now completed in Taiwan. The program is advancing toward New Drug Application (NDA) submission.
The research paper has been published in International Immunopharmacology.
Full article available at: https://doi.org/10.1016/j.intimp.2025.115964
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com