Bone regeneration: stem cell therapies and clinical studies in orthopaedics and traumatology

Introduction Characterization of cells for bone regeneration in human beings State of the art in bone tissue engineering Biomaterials for scaffolding mesenchymal stem cells Future trends in bone tissue engineering Clinical targets for cell therapy in orthopaedics Current clinical problems and therapeutic approaches Potential clinical applications of cell based therapies for bone repair Data reported in clinical studies Selected paediatric bone disorders and cellular therapies Inborn errors of bone metabolism and cellular therapy Degenerative bone disorders in childhood Ethical aspects of EU clinical trials Ethics related to information and consent Approval of the studies Ethics related to privacy/data protection Ethics related to the risk-benefit assessment Ethics related to protection of the health of persons involved in clinical trials Ethics related to transparency regarding research results Future directions and remarks Regenerative medicine seeks to repair or replace damaged tissues or organs, with the goal to fully restore structure and function without the formation of scar tissue. Cell based therapies are promising new therapeutic approaches in regenerative medicine. By using mesenchymal stem cells, good results have been reported for bone engineering in a number of clinical studies, most of them investigator initiated trials with limited scope with respect to controls and outcome. With the implementation of a new regulatory framework for advanced therapeutic medicinal products, the stage is set to improve both the characterization of the cells and combination products, and pave the way for improved controlled and well-designed clinical trials. The incorporation of more personalized medicine approaches, including the use of biomarkers to identify the proper patients and the responders to treatment, will be contributing to progress in the field. Both translational and clinical research will move the boundaries in the field of regenerative medicine, and a coordinated effort will provide the clinical breakthroughs, particularly in the many applications of bone engineering.