Abstract
Skeletal injuries requiring bone augmentation techniques are increasing in the context of avoiding or treating difficult cases with bone defects, bone healing problems, and bone regeneration limitations. Musculoskeletal severe trauma, osteoporosis-related fractures, and conditions where bone defect, bone collapse or insufficient bone regeneration occur are prone to disability and serious complications. Bone cell therapy has emerged as a promising technique to augment and promote bone regeneration. Interest in the orthopaedic community is considerable, although many aspects related to the research of this technique in specific indications may be insufficiently recognised by many orthopaedic surgeons. Clinical trials are the ultimate research in real patients that may confirm or refute the value of this new therapy. However, before launching the required trials in bone cell therapy towards bone regeneration, preclinical data is needed with the cell product to be implanted in patients to ensure safety and efficacy. These preclinical studies support the end-points that need to be evaluated in clinical trials. Orthopaedic surgeons are the ultimate players that, through their research, would confirm in clinical trials the benefit of bone cell therapies. To further foster this research, the pathway to eventually obtain authorisation from the National Competent Authorities and Research Ethics Committees under the European regulation is reviewed, and the experience of the REBORNE European project offers information and important clues about the current Voluntary Harmonization Procedure and other opportunities that need to be considered by surgeons and researchers on the topic.
Highlights
Bone healing augmentation through bone regeneration seeks to repair or replace damaged bone, with the goal to fully restore structure and function
Osteoporosis-related fractures require bone defect filling and structural support, and this epidemy in industrialized countries is especially aggressive in Northern Europe, where 46.4 % of females over 65 are predicted to have a fragility fracture [8], and in Southern Europe [9], where some of these are associated to complications with trabecular compression and derived bone defects, and related to suboptimum healing potential
A substantial interest and development of bone cell therapy can be found in many orthopaedic surgeons and departments
Summary
Bone healing augmentation through bone regeneration seeks to repair or replace damaged bone, with the goal to fully restore structure and function. While cell-based therapies are promising new therapeutic approaches, their clinical application is still under discussion. The burden of skeletal injuries and bone diseases that could benefit from regenerative medicine approaches includes bone defects of traumatic origin, and bone healing delays and nonunions, osteonecrotic damage, or other situations where bone regeneration is required but osteogenic potential is insufficient. By using mesenchymal stem cells (MSCs), good results have been reported for bone engineering in a number of early clinical studies [1], 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 (ATMPs) in Europe, both the characterization of the cells and combination products need to be more clearly defined.
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