Descripción del proyecto
CELL THERAPY TO FOSTER BONE REGENERATION IN COMPLEX SITUATIONS IS BEING CLINICALLY TESTED, FREQUENTLY BASED IN AUTOLOGOUS MESENCHYMAL STEM CELLS (MSCS). ALLOGENIC ALTERNATIVES IN CASE OF LIMITED OSTEOGENIC POTENTIAL (ELDERLY PATIENTS WITH OSTEOPOROTIC FRACTURES) ARE SCARCELY DEVELOPED. THIS PROPOSAL WILL PROVIDE PRECLINICAL STUDIES ON ADULT HUMAN DECIDUAL MESENCHYMAL STEM CELLS (DMSCS) TO SCREEN THEIR BEHAVIOUR AND INTERACTION IN SELECTIVE OSTEOINDUCTIVE MICROENVIRONMENTS WITH BIOMATERIALS IN CURRENT CLINICAL USE, IN ORDER TO ASCERTAIN THE OSTEOGENIC POTENTIAL OF THESE CELLS. IN VITRO (CELL CULTURE IN 2D AND 3D IN A BIOREACTOR) AND ANIMAL MODELS WILL HELP TO EXPLORE SAFETY ISSUES, INCLUDING CELL TRACING, AND TO EVALUATE THE ABILITY OF THESE CELLS TO FORM NEW BONE UPON IMPLANTATION. CELL PRODUCTION SCALING UNDER GMP CONDITIONS TOWARDS THE RELEASE OF A SAFE AND EFFICACIOUS INVESTIGATIONAL MEDICINAL PRODUCT (IMP) WILL BE DEVELOPED AND STANDARDIZED. THE FINAL PRODUCT WILL BE ASSESSED IN PRECLINICAL MODELS TO CONFIRM THE VIABILITY IN THE INTENDED APPLICATION. AN IMP DOCUMENT BASED ON THE RESULTS OF THE PROPOSED INVESTIGATION WILL ALLOW TO READILY INITIATE SUBSEQUENT EARLY PHASE CLINICAL TRIALS.