Technical Aspects of Preparation of Stem Cells for Neonatal Disease

The vision of stem cell therapy appears simple: harvest cells from human tissues, isolate and expand the stem cells and then transfuse or transplant them to the patient. However, translating research findings into routine therapies is a complex, multistep process, needed to comply with regulatory guidelines. To cope with the novel cell therapy products, within the European Union, many cell therapy products are classified as advanced therapy medicinal products (ATMP). A specific regulatory framework has been implemented from 2009 requiring centralized evaluation, classification and certification. Here the challen…