UnicoCell Biomed Co., Ltd. focus on researching and developing stem cells and its derived technology for medical applications.
There are two clinical trials going with new drug ELIXCYTE®: 1) Phase III clinical trial for knee osteoarthritis is under recruiting; 2) Phase I/II clinical trial for chronic kidney disease has been completed and will be unblinded in 2023.
The Allogeneic Cell Bank of UnicoCell received acknowledgment letter of US FDA DMF (Drug Master File) and it can be used as the best choice for cell starting material for the development and research of various indications.
The company has designed a robust build-in quality system in the laboratory which had been certified by TFDA as a Good Tissue Practice laboratory, Cell Processing Unit and Human Organ Storage facility, by PMDA of Japan as an overseas Cell Processing Center, and by TAF as an ISO 17025 laboratory.
UnicoCell has also been certified as a qualified supplier of autologous stem cell drug to partner with hospitals to carry out treatment of knee osteoarthritis and difficult wounds under“Administrative Regulation on Special Medical Instruments and Inspection Techniques”.
In addition, UnicoVial®, a patented cryovial developed by UnicoCell, was approved by TFDA as a class II medical device.
Conditioned medium produced with production process patent is under pre-clinical study for therapeutic use.
UnicoCell is a stem cell technology company with diversified applications.