2023.03.22 UnicoCell Receives US FDA Approval to Conduct Phase III Clinical Trial for Knee Osteoarthritis Treatment


UnicoCell Biomed Co., Ltd. (UnicoCell) was notified by the Clinical Research Organization (CRO) in March, 2023, that the U.S. Food and Drug Administration (FDA) has approved its application to conduct a phase III clinical trial for the treatment of knee osteoarthritis. 

This is yet another piece of good news, following the approval granted last month by Taiwan’s Ministry of Health and Welfare (MOHW) for UnicoCell to conduct a phase III clinical trial with the new allogeneic adipose-derived mesenchymal stem cell drug, ELIXCYTE®. The phase III clinical trial request for the same indication has now also been approved by the US FDA. UnicoCell already completed the phase I/II trial in Taiwan, results showing that injection of ELIXCYTE® relieved pain and stiffness of the patients earlier and duration of the effectiveness was longer when compared with the control group. The findings of the phase I/II clinical trial were published in the international journal Stem Cell Research & Therapy on October 30, 2021. In addition to receiving approval in the US and Taiwan, the company has completed recruiting patients with chronic kidney disease for phase I/II clinical trials. These achievements go to show that the R&D capability and clinical strength of UnicoCell are well recognized at home and abroad.

The research team at UnicoCell has been engaged in the development of new stem cell drugs for regenerative medicine for more than a decade, with the goal of providing an opportunity to enjoy better quality of life for patients suffering from degenerative or irreversible diseases. With the regenerative, differentiation and repair potential of stem cells, it is a promising regenerative medicine treatment for the vast population of patients suffering from knee osteoarthritis. The drug used in the clinical trial, ELIXCYTE®, has been recognized with the Gold Award in the Medicinal Product Category at the Pharmaceutical Technology & Research Development Award organized jointly by the MOHW and the Ministry of Economic Affairs in 2021. It is currently the only cellular drug that has been granted the top award. Moreover, ELIXCYTE® obtained the U.S. FDA's DMF (Drug Master File) registration application approval in 2022, showing that UnicoCell has highly stringent standards for the safety and quality of its new drugs. The company also presently engaged in the preclinical development projects on of retinal degenerative diseases and difficult wounds. UnicoCell Biomed is definitely a pioneer in the development of new allogeneic adipose-derived stem cell drugs in Taiwan. 


Contact: Terry Lee

Phone: 886-2-27922699

Mail: info@unicocell.com