Precision Medicine in Ortho-Biologics: A Paradigm Shift in Regenerative Therapies
Keywords:
Osteoarthritis, Knee, Platelet-Rich Plasma, Precision Medicine, Biomarkers, Treatment Outcome.Abstract
Background: Orthobiologic therapies for musculoskeletal conditions show therapeutic promise but yield highly variable outcomes due to biological heterogeneity among patients with similar diagnoses. Precision medicine approaches incorporating biomarker-driven patient stratification, advanced imaging, and artificial intelligence offer potential to individualize treatment selection. However, an integrated framework for translating precision orthobiologics into clinical practice remains elusive.
Methods: This two-arm, parallel-group comparative study enrolled 146 patients with knee osteoarthritis (Kellgren-Lawrence grade II–III) allocated to a Stratified (biomarker-guided) PRP group (n=73) or Standard (non-stratified) PRP group (n=73) from July 2025 to December 2025. Primary outcome was change in WOMAC score from baseline to 12 months. Secondary outcomes included VAS pain, KOOS, and MRI-measured cartilage thickness. Baseline inflammatory biomarkers (IL-1β, IL-6, TNF-α, MMP-3, VEGF) were assessed for stratification and correlation analyses.
Results: The Stratified group demonstrated significantly greater WOMAC improvement at 12 months (35.4 ± 5.4 vs. 24.0 ± 4.6 points; Cohen's d = 2.26, p < 0.001), persisting after ANCOVA adjustment (β = -11.32, p < 0.001). Secondary outcomes similarly favored the Stratified group (all p < 0.001; Cohen's d range: 1.07–2.64). Baseline IL-6 and TNF-α did not significantly correlate with WOMAC improvement (p > 0.05), suggesting stratification benefits arise from matching therapy to broader biological profiles rather than inflammation intensity alone. Adverse events and dropout rates did not differ between groups.
Conclusions: Biomarker-guided PRP stratification produced substantially greater improvements in pain, function, and cartilage structure than a standardized protocol, supporting a shift toward individualized, biology-informed orthobiologic treatment selection. These proof-of-concept findings require validation in real-world, multicenter cohorts.
