Translation from research to GMP-compliant manufacturing: constructing a business model for a new stem cell source

Cell based therapies promise to be a cure for many incurable diseases. However, despite extensive investments in the last two decades, most cell-based therapies have failed to deliver clinical and financial success. Particularly, autologous products are still too expensive compared to conventional therapies. We want to report on a newly developed and easily accessible stem cell source: Sweat Gland-derived Stem Cells (SGSC). Based on a patented cell isolation process, stem cells are effec- tively derived out of a small axillary skin biopsy that can be obtained in an ambulant procedure within few minutes. The cells are already well characterized and tested: we could show the potential for multilineage differentiation and conducted several preclinical tests using SGSCs in wound healing models. Highly proliferating stem cells were even derived from elderly patients, indicating that the cell source is suitable for autologous treatments of patients of all ages. Currently, we are developing a roadmap for transition into clinical practice: GMP-compli- ant process steps are being implemented and corresponding regulatory agencies are approached. Furthermore, we derived a business model combining an autologous stem cell treatment with stem cell banking for adult high risk patients, delivering an autologous ‘‘off-the-shelf’’ product. This business model might be particularly promising for treat- ment of chronic diseases from both, a clinical and economic perspec- tive. In this talk, we present our experiences with this newly developed stem cell source and the strategies that a state-funded research organi- zation like Fraunhofer pursues to commercialize regenerative thera- pies