UnicoCell

With over 10 years of experiences on research and development of stem cell technology, UnicoCell has designed a robust build-in quality system in our facility which has been certified by governments and accreditation agent:

*The only cell bank in Taiwan with FDA Master File (MF) registration and approval

* From donor qualification to cell bank establishment, all processes strictly adhere to ICH guidelines

* Passed comprehensive safety and viral testing

* Good Tissue Practice laboratory and Human Organ Storage facility by Taiwan FDA

* Overseas Cell Processing Center by PMDA of Japan

* ISO 17025 laboratory by Taiwan Accreditation Foundation, member of International Laboratory Accreditation Cooperation

To accomplish our vision of promoting widespread application of cell technology, we keep pushing forward to enhance our quality system and proprietary process in the new PIC/S GMP factory to scale up production capacity and to ensure the consistency of quality.

 

The new stem cell drug " ELIXCYTE^®" developed by UnicoCell has successively obtained the approval of Investigational New Drug (IND) Application by Taiwan FDA (CT21, CT31) and US-FDA (CT31) to be tested in clinical trials. 

Derived from UnicoCell's allogeneic cell bank, ELIXCYTE^® is currently undergoing Phase 3 clinical trials for knee osteoarthritis, while Phase 1/2 clinical trials for chronic kidney disease have been completed and are now in the data analysis stage. ELIXCYTE^® not only rigorously oversees its source materials but also maintains a stringent quality management system. Its safety and efficacy have been recognized by the U.S. FDA's Master File, positioning it for a streamlined drug approval process in the future. These outstanding characteristics position UnicoCell's allogeneic cell bank as a leading source for clinical trials and academic research.

 

 

ELIXCYTE® treatment for knee osteoarthritis

Mechanism of actions of ELIXCYTE^®

1. Immune regulation, suppression of inflammation

2. Promote the proliferation of chondrocytes

3. Protect and repair damaged cartilage cells to maintain normal functions

The pathological feature of osteoarthritis is continuous deterioration and irreversible cartilage degradation, which causes pain, stiffness, and decreased function, and is one of the main causes of inconvenience and obstacles. The current treatment strategies for osteoarthritis are mainly to relieve pain and control symptoms. According to the cell model pharmacological research and animal knee osteoarthritis model efficacy studies,  ELIXCYTE® has been proved that  ELIXCYTE® has significant functions including immune regulation, suppression of inflammation, promotion of the proliferation of chondrocytes and maintenance of the normal function of damaged chondrocytes, and can relief the pain response and maintenance normal cartilage structure.

ELIXCYTE® treatment for chronic kidney disease

Mechanism of actions of ELIXCYTE^®

1. Immune regulation, suppression of inflammation

2. Inhibition of fibrosis

3. Anti-oxidation and protection of kidney cells

4. Promotion of angiogenesis

The kidneys undergo irreversible damages due to long-term inflammation, diabetes, high blood pressure, or structural damage to the kidney itself, leading to the gradual disappearance of normal kidney functions. It is called chronic kidney disease (CKD).  Current treatment for chronic kidney disease mainly focuses on the control of the primary disease and related complications to slow down the deterioration of kidney function. Our pharmacological studies revealed that  ELIXCYTE® has significant immune regulation, inhibition of inflammation, protection of kidney cells damaged by oxidative stress, and promotion of angiogenesis. A significant improvement in inflammation and improvement in fibrosis can be observed in kidney tissues in our chronic kidney disease animal model studies.