For a decade, UnicoCell Biomed has focused on the R&D of stem cell therapy.
UnicoCell's Gold Award-winning new stem cell product, ELIXCYTE, has advanced to the case recruitment in phase III trial for knee osteoarthritis and has reached the data analysis stage in phase I/II trial for chronic kidney disease, promising innovative treatments for aging-related diseases.
Our core philosophy is to promote human health, improve quality of life, and maintain the dignity of the elderly.
The quality system of UnicoCell Biomed has passed inspection by Japan PMDA and Taiwan FDA.
Our company held the FDA Master File (MF) in 2022 in accordance with ICH regulations for an allogeneic stem cell bank, a vital raw material for stem cell drug development. Furthermore, UnicoCell has obtained two patented products, one is for the patented production process of stem cell conditioned medium (UCCM), which can significantly increase the concentration of stem cell secretome. Another is for UnicoVial, a storage container that is easy for clinical use and long-term stable storage. UnicoVial is certified by TFDA as a class II medical device and filed by FDA MF.
UnicoCell Biomed has been certified as a qualified supplier of autologous stem cell drugs to partner with hospitals to carry out treatment of osteoarthritis and wound healing under "The Regulation Governing the Application of Specific Medical Examination Technique and Medical Device".
Therefore, UnicoCell Biomed is a fully developed company in the field of stem cell research, development, and application.