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Exosome Orthobiologics in Sports Medicine and Orthopaedics: The Exosome Orthobiologic Accountability Framework (EOAF) for Responsible Clinical Adoption

Year: 2026

Type: article

Abstract: Exosome-based orthobiologics have emerged as a potential cell-free regenerative strategy in sports medicine and orthopaedics through extracellular vesicle (EV)-mediated modulation of inflammation and tissue repair. However, translation into clinical practice remains limited by heterogeneous product definitions and manufacturing methods, inconsistent characterization, uncertain potency, and limited high-level clinical evidence. This narrative review examines EV biology, musculoskeletal applications, consensus standards, and regulatory considerations relevant to clinical translation. PubMed and Google Scholar were searched from December 2025 through April 2026 for scientific literature addressing EV biology, musculoskeletal applications, product characterization, clinical evidence, safety, and regulation, supplemented by relevant regulatory and consensus sources. Recurring scientific, regulatory, patient-safety, and governance considerations identified during the review informed development of the EOAF domains. Because the term "exosome" is frequently applied to heterogeneous EV preparations without confirmation of exosomal biogenesis, EV is used as the preferred terminology where appropriate, while "exosome" is retained when referring to vesicles of established exosomal origin or products marketed as "exosomes". Based on the considerations identified in the reviewed literature, we propose the Exosome Orthobiologic Accountability Framework (EOAF), an unvalidated due-diligence model comprising five domains: Regulatory Accountability, Product Accountability, Evidence Accountability, Patient Accountability, and Governance Accountability. These domains organize the evaluation of regulatory status, product identity and manufacturing transparency, evidence quality, patient protection, and institutional oversight. The EOAF is intended as a conceptual framework rather than a validated clinical decision tool and requires stakeholder evaluation and prospective validation before its clinical utility can be established. Current evidence supports the biological potential of EV-based therapies, but routine musculoskeletal use remains constrained by limited clinical evidence and insufficient product standardization. Future translation will require reproducible manufacturing, rigorous EV characterization, validated potency assays, long-term safety assessment, and well-designed clinical trials.

Source: Orthopedic Research and Reviews

DOI: 10.2147/orr.s641316