We are the only biotechnology company in Lithuania and one of the few in the entire European Union to be granted the license for the production of investigational advanced therapy medicinal products No. 0914 (see SMCS official website). This allows the production of somatic cells and tissue engineering products for clinical trials.
The company has implemented a quality management and traceability system, taking into account GMP (Good manufacturing practice) and EU requirements for the production of investigational medicinal products.
The quality of investigational medicinal products is assessed and medicinal products for clinical use are certified by a Qualified person who meets the highest EU qualification and experience requirements.
Clinical trials planned:
Phase I first human study to determine the safety and suitability of a personalized intravenous product for the treatment of chronic venous insufficiency (Client: Verigraft (Sweden), Manufacturer: Froceth (Lithuania), Organization of Clinical Trials (CRO): Clinical Accelerator (Lithuania)).
Study of the efficacy of chemoimmunotherapy with autologous dendritic cell preparations in the treatment of patients with stage III ovarian cancer (Client: Froceth (Lithuania), Clinical Research Center: National Cancer Institute (Lithuania), Organization of Clinical Trials (CRO): Clinical Accelerator (Lithuania)).