UnicoCell Biomed Co., Ltd. (“UnicoCell”) has received notification of approval to conduct a phase III clinical trial from the Ministry of Health and Welfare on February 8, 2023.
UnicoCell has completed phase I/II clinical trial of ELIXCYTE, an allogeneic adipose-derived mesenchymal stem cell drug, for the treatment of knee osteoarthritis. The clinical result showed that injection of ELIXCYTE conferred the earlier onset of reductions in pain and stiffness and with the longer duration of the effectiveness than the control group. The result of the phase I/II clinical trial was published in the journal Stem Cell Research & Therapy on October 30, 2021. Now the company has received notification of approval to conduct a phase III clinical trial from the Ministry of Health and Welfare. 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.
Regenerative medicine offers new therapeutic possibilities for diseases caused by irreversible damage to organs or tissues. UnicoCell has focus on researching and developing stem cells and its derived technology for medical applications for over a decade, with the goal of finding alternative solutions for patients suffering from degenerative or irreversible diseases to pursue a better quality of life and dignity. The clinical trial of ELIXCYTE, a new stem cell drug for the treatment of chronic kidney disease, is the first stem cell clinical trial in Taiwan to be approved by both the U.S. FDA and Taiwan FDA. The company has completed recruiting patients for phase II clinical trial of chronic kidney disease, with unblinding result expected to be released after one-year follow-up. ELIXCYTE has been recognized with Gold Award by the Ministry of Health and Welfare and the Ministry of Economic Affairs in the Medicinal Product Category of the Pharmaceutical Technology & Research Development Award in 2021, which is the only new cellular drug that has been granted with the gold award. This again demonstrated the solid R&D strength and achievement of UnicoCell. Currently the company has pre-clinical studies projects on retinal degenerative diseases and difficult wounds. Overall, UnicoCell is indeed a pioneer in the development of new allogeneic adipose-derived stem cell drugs in Taiwan..
In addition, UnicoCell has partnered with renowned medical centers to carry out the treatment of knee osteoarthritis and chronic wounds with autologous stem cells under RASMET (“The Regulation Governing the Application of Specific Medical Examination Technique and Medical Device”). Among the partnered hospitals, Shin Kong Wu Ho Su Memorial Hospital has received approval for treatment of chronic wound; Lin Kou Chang Gung Hospital, Shuang Ho Hospital, the Tri-Service General Hospital, Jing Mei Hospital and Kaohsiung Chang Gung Hospital have received approval for treatment of knee osteoarthritis with autologous cell therapy, a breakthrough and potential treatment for patients with degenerative arthritis.
Contact: Terry Lee