Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference.
Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference.
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DOI：
10.5435/jaaos-d-18-00305
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发表时间：
2019-01-15
期刊：
影响因子：
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通讯作者：
Maloney W
中科院分区：
文献类型：
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作者：
Chu CR;Rodeo S;Bhutani N;Goodrich LR;Huard J;Irrgang J;LaPrade RF;Lattermann C;Lu Y;Mandelbaum B;Mao J;McIntyre L;Mishra A;Muschler GF;Piuzzi NS;Potter H;Spindler K;Tokish JM;Tuan R;Zaslav K;Maloney W
人们担心，来自直接面向消费者营销的大量未经证实的“生物”治疗（如富血小板血浆和细胞疗法）的错误信息可能会侵蚀公众的信任，以及为患者提供合法生物疗法所需的负责任投资，这导致专业组织和管理机构呼吁采取行动。为了满足患者对骨科疾病生物治疗的大量需求，美国骨科医师学会召开了一次合作研讨会，并建立了一个共识框架，以改善和加速肌肉骨骼疾病生物治疗的临床评价、使用和优化。肌肉骨骼疾病的经济和疾病负担很高。在讨论的各种疾病中，膝关节骨关节炎被确定为与大量和进行性发病相关的“严重疾病”，并成为最迫切需要进行临床试验开发的疾病。还认识到干细胞具有最低限度操作的混合细胞制剂所不满足的独特特征。工作组建议将最低限度操作的细胞产品称为细胞疗法，并在专业范围内向患者和公众明确传达这些治疗的未经测试和未经表征的性质。还应遵循产品表征和临床研究的最低标准。就开发膝关节OA相关临床试验的框架达成一致。除了建议开展高质量的多中心临床试验外，另一项重要建议是提供生物治疗的医生和机构应致力于建立高质量的患者登记和生物定位相关登记，以用于上市后监测和质量评估。
Concern that misinformation from direct-to-consumer marketing of largely unproven “biologic” treatments such as platelet-rich plasma and cell-based therapies may erode the public trust and the responsible investment needed to bring legitimate biological therapies to patients have resulted in calls to action from professional organizations and governing bodies. In response to substantial patient demand for biologic treatment of orthopaedic conditions, the American Academy of Orthopaedic Surgeons convened a collaborative symposium and established a consensus framework for improving and accelerating the clinical evaluation, use, and optimization of biologic therapies for musculoskeletal diseases. The economic and disease burden of musculoskeletal conditions is high. Of the various conditions discussed, knee osteoarthritis was identified as a “serious condition” associated with substantial and progressive morbidity and emerged as the condition with the most urgent need for clinical trial development. It was also recognized that stem cells have unique characteristics that are not met by minimally manipulated mixed cell preparations. The work group recommended that minimally manipulated cell products be referred to as cell therapy and that the untested and uncharacterized nature of these treatments be clearly communicated within the profession, to patients, and to the public. Minimum standards for product characterization and clinical research should also be followed. A framework for developing clinical trials related to knee OA was agreed upon. In addition to recommendations for development of high-quality multicenter clinical trials, another important recommendation was that physicians and institutions offering biologic therapies commit to establishing high-quality patient registries and biorepository-linked registries that can be used for postmarket surveillance and quality assessments.