UnicoCell Biomed Co., Ltd. (“UnicoCell” , stock code:6794) today announced that its Phase III clinical trial of ELIXCYTE®, an allogeneic adipose-derived mesenchymal stem cell (MSC) investigational new drug for the treatment of knee osteoarthritis (OA), has reached a significant milestone. The last patient has been successfully enrolled on November 12. The study will continue with a 1 year follow-up period before unblinding.
This Phase III study of ELIXCYTE® received clinical trial approval from both the Taiwan Food and Drug Administration (TFDA) in February 2022 and the U.S. Food and Drug Administration (FDA) in March 2023. The trial is designed to enroll patients with unilateral or bilateral knee osteoarthritis graded II–III. Results from the prior Phase I/II trial were published in Stem Cell Research & Therapy on October 30, 2021, and demonstrated potential efficacy, drawing significant scientific and clinical attention.
With its regenerative, differentiative, and reparative potential, stem cell therapy represents a highly anticipated new treatment option in regenerative medicine for the large population of patients suffering from degenerative osteoarthritis. ELIXCYTE® has already been recognized for its innovation and impact, winning First Prize (Gold Award) in the Drug Category of the prestigious National Drug Technology Research and Development Awards in 2021, jointly organized by Taiwan’s Ministry of Health and Welfare (MOHW). It remains the only cell therapy product to have received this prestigious honor to date. Furthermore, in 2022, ELIXCYTE® obtained U.S. FDA approval for its Drug Master File (DMF) submission, reflecting UnicoCell’s rigorous commitment to safety and quality standards.
In addition to the new drug development program, UnicoCell has also partnered with leading hospitals in Taiwan under the Special Regulation for Cell Therapy to provide autologous cell therapy for osteoarthritis patients. Currently, hospitals authorized to conduct such treatments include Linkou Chang Gung Memorial Hospital, Far Eastern Memorial Hospital, and Pao Chien Hospital. These hospitals are now able to offer patients with degenerative osteoarthritis an innovative and promising therapeutic option.
Looking ahead, with the successful completion of patient enrollment for the Phase III clinical trial, ELIXCYTE®—Taiwan’s first stem cell new drug for the treatment of knee osteoarthritis will advance to the next stage following unblinding and confirmation of efficacy and safety results. Based on the solid clinical research outcomes, UnicoCell plans to actively pursue regulatory submissions and commercialization strategies in Taiwan, the United States, and other target markets, including global strategic partnerships, licensing, and marketing opportunities.
With the Ministry of Health and Welfare expected to complete the promulgation and implementation of the sub-regulations under the “Regenerative Medicine Act” and the “Regenerative Medicinal Products Act” by the end of 2025, full enforcement is anticipated in 2026. Under the new regulatory framework, conditional marketing authorization with a validity period of up to five years may be granted for therapies intended to treat life-threatening or severely disabling disease that have completed Phase II clinical trials, in order to enhance early patient access to innovative treatments.
Given that degenerative knee osteoarthritis is a progressive condition that can lead to disability, and UnicoCell has already completed Phase I/II clinical trial for this indication, the company is positioned to pursue conditional approval under the new framework. UnicoCell plans to apply for such authorization based on the established efficacy and safety data, with the goal of enabling patients to benefit from this innovative therapy at an earlier stage, while expediting the market deployment and clinical adoption of regenerative medicine products in Taiwan.
As the global population continues to age and the number of osteoarthritis patients continues to rise, currently estimated to exceed 500 million worldwide, ELIXCYTE® holds the potential to address a substantial and urgent unmet medical need, bringing a new therapeutic option to patients suffering from degenerative joint disease.
Contact: Ray Liu
Phone: 886-2-27922699
Mail: info@unicocell.com