2022.8.22 The Ministry of Health and Welfare approved the application for the "Cell Process Unit" in cooperation with the Kaohsiung Chang Gung Memorial Hospital.
UnicoCell was approved as a qualified Cell Process Unit by the Ministry of Health and Welfare (MOHW) in cooperation with Kaohsiung Chang Gung Memorial Hospital in accordance with the "The Regulations Governing the Application of Specific Medical Examination Technique and Medical Device" (RASMET), to produce autologous cellular product for the treatment of osteoarthritis of the knee joint. The Cell Process Unit is in compliance with the Good Tissue Practice (GTP) for human cells.
UnicoCell's business is centered on regenerative medicine. We focus on researching and developing stem cells and its derived technology for medical applications, with the goal of advancing human health and improving quality of life.
Our Gold Award new stem cell investigational product ELIXCYTE® has been tested on clinical trials for degenerative knee osteoarthritis (Phase I/II clinical trial completed) and chronic kidney disease (Phase I/II clinical trial).
Our facility and quality system have been certified by the Ministry of Health and Welfare of Taiwan as a GTP laboratory and a human organ storage facility, by PMDA of Japan as an Overseas Cell Processing Center (CPC), and by TAF ISO 17025 as a qualified test laboratory. In addition to the cooperation project with the Kaohsiung Chang Gung MemorialHospital, we have also cooperated with Lin Kou Chang Gung Hospital, Shuang Ho Hospital of MOHW, Tri-Service General Hospital and Jingmei Hospital in the treatment of osteoarthritis of the knee joint under the "The Regulations Governing the Application of Specific Medical Examination Technique and Medical Device" (RASMET).