European Perspective on Cellular Therapy

Hematopoietic stem cell transplantation (HSCT) for autoimmune diseases has been evolving since the 1990s at hospitals around the world. Similar to HSCT for cancer, it falls under Good Tissue Practice (GTP) regulations. These regulations on HSCT are less stringent since hematopoietic stem cells (HSCs) are only minimally manipulated and are used for their normal homologous application, effectively a blood transfusion. In contrast, the manufacturing of cells or gene therapy-based medicinal products requires compliance with more stringent regulation, referred to as Good Manufacturing Practices (GMP), which was originally developed for large-scale manufacturing of conventional medicinal drugs. The application of GMP is challenging, expensive, and associated with unprecedented responsibilities and issues for academic institutions and hospitals.