Innovative Cell Therapies for Bone Regeneration

Bone defects due to ablative surgery, injuries and pathological and physiological bone resorption still represent a major challenge. Current clinical treatments to repair bone defects are problematic and often yield poor healing due to the complicated anatomy and physiology of bone tissue, as well as the limitations of medical technology. Autologous bone transplantation is still considered gold standard. Skeletal defects may require volumes of bone, locally not available. On the other hand, the use of advanced therapy, in the form of somatic cell therapy and tissue engineered products, has been recently increased and the perspective of their use for bone repair are very. Bone marrow derived mesenchymal stem cells (BMSCs) are multipotent stem cells capable of differentiating into bone, cartilage and adipocytes. Starting from a bone marrow aspirate of 10-30 ml, BMSCs are easily isolated by adherence on treated culture plastic and amplified in culture up to several hundred million of cells in 21 days. Autologous BMSCs have been successfully used to treat bone defects in human patients. However, after reviewing all clinical database and medline, it appears that there are only few early stage clinical studies with a limited number of patients (phase I) that have proven safety of this regenerative treatment. Therefore, there is a need to perform randomized late stage comparative clinical trials to demonstrate equivalent efficacy of cells and biomaterials advanced therapy medicinal products in comparison to the current autologous bone grafting procedure. A new collaborative and innovative project in Research and Development is under construction. The project will be submitted during April 2017 to the EU Commission under the topic H2020-SCI-2017 aim at promoting cell therapy as an alternative approach for bone regeneration.