Stammzelltherapie in Deutschland: Was ist umsetzbar und sinnvoll?

Over the last decade the clinical application of concentrated bone marrow or adipose tissue aspirates as well as culture-expanded stem cells has enhanced the clinical options for articular cartilage treatment. In particular, single-stage procedures with sampling of bone marrow or adipose tissue aspirates with intraoperative preparation of cell concentrates appear to be an attractive strategy and are advertised by various manufacturers as unproblematic point of care (PoC) procedures; however, one should be aware that by applying this technology, the surgeon automatically becomes the manufacturer of a drug within the statutory framework of the German Medicinal Products Act (AMG). Therefore, it is compulsory to notify the regulatory authorities of the clinical application of the cell product. The various procedures for production of cell products are then classified according to the form of processing (substantial or nonsubstantial) and the intended application (homologous or nonhomologous use). Cell products that are classified as advanced therapy medicinal products (ATMP) unconditionally necessitate permission for the sampling and manufacturing, which can only be acquired in cooperation with the competent authorities (e.g. Paul Ehrlich Institute, European Medicinal Agency). The knowledge of and compliance with the regulatory framework conditions for the application of intraoperatively harvested bone marrow and adipose tissue aspirates as well as culture-expanded cells are essential for the medical profession to ensure a legally compliant administration in the treatment of articular cartilage diseases. The clinical results on the application of cell concentrates or ex vivo expanded mesenchymal stem cells are difficult to compare due to the heterogeneous production techniques, the different study designs and the lack of randomized studies. Therefore, a conclusive assessment with respect to the effectiveness is currently not possible.