VASCUBONE · Construction kit for tailor-made vascularized boneimplants

The goal of VascuBone is to develop a “tool box” for bone regeneration, which on one hand fulfils basic requirements and on the other hand is freely combinable with what is needed in the respective patient’s situation. The tool box will include a variation of biocompatible biomaterials and cell types, FDA approved growth factors, material modification technologies, simulation and analytical tools like molecular imaging based in vivo diagnostics which can be combined for the specific medical need. This tool box will be used to develop translational approaches for regenerative therapies of three different types of bone defects. The chosen bone diseases differ in their requirements, to ensure a successful implementation and translation. Additionally this implementation strategy is characterized by high complexity to remove bottlenecks and limitations of bone regeneration identified in the clinical setting. Therefore definite quality criteria have to be evaluated concerning an optimal stem cell source/subpopulation as well as GF concentrations and their bioactivity in vivo. Furthermore quantitative evaluation will focus on the definition of differences between stem cell populations responsible for bone regeneration in young and old people, as a prerequisite for the development of regenerative therapies for the ageing European society. Considering a successful and prompt approval of the biomaterial, for each clinical application a minimum of modification steps in daily routine must be identified. The road map of the project and clinic trials contains pre-determined milestones, to ensure efficacy, safety, and immunological acceptance of the implant. The efficacy is quantified by high innovative MRI and PET/CT technology which is able to demonstrate the regenerative effect of biomaterials and cells in vivo. Based on the clinical data the proposal as “Advanced Therapeutical Medicinal Product” will be submitted to the European Medicines Agency at the end of the project.