UnicoCell BioMed has a complete R&D team dedicated to the research of pharmacology of stem cell drug and manufacturing technology, including the development of in vitro platforms for mechanism of actions (MOAs), characteristics of stem cell product, and optimization of the manufacturing process.
The stem cell drug "ELIXCYTE", has been successively approved by TFDA and US-FDA for Investigational New Drug (IND) application. Currently, there are two indications of ELIXCYTE clinical trials, one is osteoarthritis (OA) and the other is chronic kidney disease (CKD). The trial of Elixcyte for OA knee was also listed as a cell therapy index case by the Taiwan CDE.
The patented product of UnicoCell, "UnicoVial Cell Storage Container", is suitable for various types of cells requiring cryo-preservation, and has received the Type II Medical device certificate issued by TFDA (MHW Medical Device Manufacturing No. 007096). UnicoVial® has been patented with Taiwan, Japan, and China; and has been widely acclaimed in the cell therapy industry, which is one of the very rare cryogenic containers categorized as a medical device. Besides, it provides a safer, advantageous, and straightforward option for R&D sectors to upgrade their operation of cell preservation toward clinical usage.