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The American Academy of Orthopaedic Surgeons (2018) formulated recommendations concerning the clinical evaluation, use, and optimization of biologic therapies for musculoskeletal diseases.
The concerns regarding the misleading information from the direct-to-consumer marketing of largely unproven “biologic” treatments, for example, platelet-rich plasma and cell-based therapies may hamper the public trust. Timely action is required with a need to clearly establish a collective impact agenda for enhancing the clinical evaluation and optimization of biologics in orthopaedics by professional organizations and governing bodies.
The American Academy of Orthopaedic Surgeons (AAOS) convened a collaborative symposium and established a consensus framework addressing the same in response to the substantial patient demand for biologic treatment of orthopaedic conditions, as explained in a Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference published in 'The Journal of the American Academy of Orthopaedic Surgeons'.Musculoskeletal conditions pose to cause a high economic and disease burden. Knee osteoarthritis (OA) was recognized as a "serious condition" concerned with substantial and progressive morbidity and was regarded as the condition with the most utmost need for clinical trial development. Stem cells were considered as having unique characteristics that are not met by minimally manipulated mixed cell preparations.
According to the workgroup, the minimally manipulated cell products needs to be referred to as cell therapy and the untested and uncharacterized nature of these treatments should be communicated within the profession, to the patients, and public. The minimum requirements for product characterization and clinical research needs to be considered. The workgroup agreed on fabricating a framework for clinical trials related to knee OA. Other than recommendations for the development of high-quality multicenter clinical trials, another significant recommendation was that physicians and institutions offering the biologic therapies pledge to establish high-quality patient registries and biorepository-linked registries. These can be later used for postmarket surveillance and quality assessments.
The Journal of the American Academy of Orthopaedic Surgeons
Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference
Constance R. Chu et al.
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