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An NIH-sponsored clinical study using synovial fluid samples from patients with midstage OA, high levels of TSG activity were significantly predictive of disease progression.
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Background: Biomarkers provide a critical element in personalized medicine and are being extensively studied in musculoskeletal medicine. There are currently no widely used, predictive biomarkers for osteoarthritis (OA) disease progression, and those that have been studied demonstrate poor discrimination between progressors and non-progressors. Moreover, current assays for inflammatory cytokines are limited to quantifying the levels of a specific biomarker, or set of biomarkers, rather than providing an integrated measure of disease activity in a biological sample. Because OA is phenotypically diverse, with some patients progressing within a 1-5 year period while others do not progress for extended periods, there is a significant unmet need for predictive OA biomarkers that can inform treatment decisions, especially decisions related to surgical options as opposed to more conservative medical measures. OA biomarkers are also especially useful for patient stratification purposes in trials of OA disease-modifying drugs, enabling cost-effective recruitment for prohibitively expensive clinical trials. The NYU-Duke team has discovered that TSG-6 activities in synovial fluids of OA patients are significantly predictive of the risk of OA progression. TSG-6 is induced by multiple pro-inflammatory cytokines and modulated by growth factors and hormones. An NIH-sponsored clinical study using synovial fluid samples from patients with midstage OA, high levels of TSG activity were significantly predictive of disease progression. Applications: Diagnostics to inform surgical decision-making for joint replacement Diagnostic for patient selection for clinical trials developing OA therapies Patent Status: Patent applications have been filed covering the use of TSG-6 activity as a measure of inflammatory activity in body fluids, and as a predictive tool to inform treatment decisions. NYU is seeking a commercial partner to focus on developing TSG-6 as a biomarker in monitoring orthopaedic and rheumatologic disease outcomes and the outcomes of other pathologies where cytokine-driven inflammation plays an etiological role that influences the course of disease and/or treatment. A putative collaboration can focus on a partner adapting this tool for clinical trial patient selection during development of OA therapeutics or developing a diagnostic tool for commercialization.