Use of Multipotent Mesenchymal Stromal Cells, Fibrin, and Scaffolds in the Production of Clinical Grade Bone Tissue Engineering Products.

Tissue engineering products (TEP) are a new type of medicines resulting from the combination of cells, scaffolds, and/or signalling factors, which can be used for the regeneration of damaged tissues thus opening new avenues for the treatment of complex conditions. However, such combination of biologically active elements, particularly living cells, poses an unprecedented challenge for their production under pharmaceutical standards.In the methods presented here, we formulated two types of TEP based on the use of multipotent mesenchymal stromal cells with osteogenic potential combined with osteoinductive and osteoconductive bony particles from tissue bank embedded in a fibrin hydrogel that, altogether, can induce the generation of new tissue while adapting to the diverse architecture of bony defects. In agreement with pharmaceutical quality and regulatory requirements, procedures presented herein can be performed in compliance with current good manufacturing practices and be readily implemented in straightforward facilities at hospitals and academic institutions.