Chapter 9: Culturing Non-hematopoietic Mesenchymal Stromal Cells and Requirements of GMP in Stem Cell-based Therapies

In the recent years MSC have merged as a clinically critical cell population for cellular therapy of a variety of indications raising a lot of expectations and hope. Whereas clinical trials have been initiated worldwide, standardized protocols for isolation, expansion and characterisation seem to lag behind. Furthermore, there is growing evidence, that “MSC” despite sharing a common name, are a heterogeneous cell population with different efficacy in different therapeutic settings. Whether they are primary heterogeneous, or whether they develop it by external stimuli or senescence is still open. Therefore one must avoid generalizing specific findings in one indication with one specific MSC preparation to other therapeutic settings. Otherwise lack of efficacy or adverse events seen with one specific preparation in a specific indication may jeopardize the whole field. For the success of cell-based therapies, we regard it as major critical issue to standardise and harmonise translational protocols to develop these processes along-side with developing therapies and not thereafter. The development of a pre-clinical efficacy test for a specific indication is therefore highly desirable but admittedly also highly challenging. Moreover, test systems with regard to potential adverse events, e.g. immunosuppression or tumorigenicity, need to be established. Contact and exchange with the regulatory authorities has to be established to agree on an appropriate test panel.