O'Keefe Regis J, Tuan Rocky S, Lane Nancy E, Awad Hani A, Barry Frank, Bunnell Bruce A, Colnot Céline, Drake Matthew T, Drissi Hicham, Dyment Nathaniel A, Fortier Lisa A, Guldberg Robert E, Kandel Rita, Little David G, Marshall Mary F, Mao Jeremy J, Nakamura Norimasa, Proffen Benedikt L, Rodeo Scott A, Rosen Vicki, Thomopoulos Stavros, Schwarz Edward M, Serra Rosa
Department of Orthopaedic Surgery, School of Medicine, Washington University, St. Louis, MO, USA.
The Chinese University of Hong Kong, Institute for Tissue Engineering and Regenerative Medicine, Hong Kong SAR, China.
J Bone Miner Res. 2020 Jan;35(1):3-17. doi: 10.1002/jbmr.3839. Epub 2019 Sep 23.
Cell-based therapies, defined here as the delivery of cells in vivo to treat disease, have recently gained increasing public attention as a potentially promising approach to restore structure and function to musculoskeletal tissues. Although cell-based therapy has the potential to improve the treatment of disorders of the musculoskeletal system, there is also the possibility of misuse and misrepresentation of the efficacy of such treatments. The medical literature contains anecdotal reports and research studies, along with web-based marketing and patient testimonials supporting cell-based therapy. Both the American Society for Bone and Mineral Research (ASBMR) and the Orthopaedic Research Society (ORS) are committed to ensuring that the potential of cell-based therapies is realized through rigorous, reproducible, and clinically meaningful scientific discovery. The two organizations convened a multidisciplinary and international Task Force composed of physicians, surgeons, and scientists who are recognized experts in the development and use of cell-based therapies. The Task Force was charged with defining the state-of-the art in cell-based therapies and identifying the gaps in knowledge and methodologies that should guide the research agenda. The efforts of this Task Force are designed to provide researchers and clinicians with a better understanding of the current state of the science and research needed to advance the study and use of cell-based therapies for skeletal tissues. The design and implementation of rigorous, thorough protocols will be critical to leveraging these innovative treatments and optimizing clinical and functional patient outcomes. In addition to providing specific recommendations and ethical considerations for preclinical and clinical investigations, this report concludes with an outline to address knowledge gaps in how to determine the cell autonomous and nonautonomous effects of a donor population used for bone regeneration. © 2019 American Society for Bone and Mineral Research.
基于细胞的疗法，在此定义为在体内递送细胞以治疗疾病，最近作为一种恢复肌肉骨骼组织结构和功能的潜在有前景的方法，越来越受到公众关注。尽管基于细胞的疗法有改善肌肉骨骼系统疾病治疗的潜力，但也存在滥用和错误表述此类治疗效果的可能性。医学文献包含轶事报道和研究，以及支持基于细胞疗法的网络营销和患者推荐。美国骨与矿物质研究学会（ASBMR）和骨科学研究学会（ORS）都致力于通过严谨、可重复且具有临床意义的科学发现来实现基于细胞疗法的潜力。这两个组织召集了一个多学科的国际特别工作组，成员包括在基于细胞疗法的开发和使用方面公认的专家，如内科医生、外科医生和科学家。该特别工作组负责界定基于细胞疗法的现有水平，并确定应指导研究议程的知识和方法方面的差距。该特别工作组的工作旨在让研究人员和临床医生更好地了解科学现状以及推进骨骼组织基于细胞疗法的研究和应用所需的研究。严谨、全面方案的设计和实施对于利用这些创新疗法并优化患者的临床和功能结果至关重要。除了为临床前和临床研究提供具体建议和伦理考量外，本报告最后还概述了如何解决在确定用于骨再生的供体细胞群体的细胞自主和非自主效应方面的知识差距。© 2019美国骨与矿物质研究学会。
