Steminent established a state-of-the-art cell processing facility following PIC/S GMP guideline in the Neihu Science Park of Taipei, dedicated to the production of cellular biotherapeutics. All stem cell production processes are validated and controlled under the stringent criteria, to ensure the safety and quality of all products.
Stemchymal® had been qualified for use in three Taiwan Food and Drug Administration (TFDA) approved clinical trials to date, at Taipei Veterans General Hospital for the treatment of:
- Sequelae of arteriovenous malformation rupture (autologous)
- Spinocerebellar ataxia (allogeneic)
- Osteoarthritis knee (autologous)
The application for an additional clinical trial using Stemchymal® for the treatment of acute liver failure has approved by TFDA.
PIC/S GMP implemented, pharmaceutical grade cell manufacturing facility.