Prima bancă de celule stem autorizată să fabrice terapii avansate

REGINA MARIA Stem Cell Bank has received authorization from ANMDMR to manufacture advanced therapy medicinal products using mesenchymal stem cells for clinical research. This is the first such authorization in Romania, allowing the bank to produce therapies for specific medical conditions. The GMP certification ensures compliance with European manufacturing standards, enhancing the bank's capabilities beyond storage to include the production of advanced therapies. This development supports clinical studies and innovative treatments for conditions with limited therapeutic options, such as bronchopulmonary dysplasia and autism spectrum disorders. The bank aims to contribute to regenerative medicine while adhering to safety standards.