Banca Centrală de Celule Stem REGINA MARIA, prima din România autorizată să fabrice produse de terapie avansată pentru studii clinice

REGINA MARIA Stem Cell Bank has received manufacturing authorization and GMP certification from ANMDMR, enabling the production of advanced therapy medicinal products using mesenchymal stem cells for clinical research. This is the first authorization of its kind in Romania, allowing the bank to expand its activities beyond processing and storage to manufacturing. The GMP certification ensures compliance with European manufacturing standards, enhancing the bank's role in regenerative medicine. The authorization facilitates participation in clinical studies for innovative therapies targeting conditions with limited treatment options, such as bronchopulmonary dysplasia and autism spectrum disorders. The bank aims to contribute to new therapeutic options in regenerative medicine.