Gómez-Barrena Enrique, Solá Cristina Avendaño, Bunu Carmen Painatescu
Department of Orthopaedic Surgery and Traumatology, Hospital La Paz and Universidad Autónoma de Madrid, Madrid, Spain,
Int Orthop. 2014 Sep;38(9):1803-9. doi: 10.1007/s00264-014-2332-z. Epub 2014 Apr 15.
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.
在避免或治疗伴有骨缺损、骨愈合问题及骨再生受限的疑难病例的背景下，需要采用骨增强技术的骨骼损伤正在增加。肌肉骨骼严重创伤、骨质疏松相关骨折以及出现骨缺损、骨塌陷或骨再生不足的情况容易导致残疾和严重并发症。骨细胞治疗已成为一种有前景的增强和促进骨再生的技术。尽管许多骨科医生可能对该技术在特定适应症方面的研究的许多方面认识不足，但骨科界对此兴趣浓厚。临床试验是针对真实患者的最终研究，可能证实或反驳这种新疗法的价值。然而，在开展骨细胞治疗促进骨再生所需的试验之前，需要对即将植入患者的细胞产品进行临床前数据研究，以确保安全性和有效性。这些临床前研究为临床试验中需要评估的终点提供了支持。骨科医生是最终的参与者，通过他们的研究，将在临床试验中证实骨细胞治疗的益处。为了进一步推动这项研究，本文回顾了根据欧洲法规最终获得国家主管当局和研究伦理委员会授权的途径，并且REBORNE欧洲项目的经验提供了关于当前自愿协调程序以及外科医生和研究人员在该主题上需要考虑的其他机会的信息和重要线索。
