変形性膝関節症に対する間葉系幹細胞由来脂肪組織由来血管成分とナノファットの一次治療における予後比較：二重盲検無作為化比較試験プロトコル

Osteoarthritis (OA) of the knee is a prevalent degenerative joint disease that significantly impairs quality of life and functional mobility. Emerging regenerative therapies, such as stromal vascular fraction (SVF) and nanofat, have demonstrated potential in cartilage repair and symptom alleviation. However, comparative clinical evidence evaluating their efficacy and safety remains limited.

To compare the clinical outcomes of SVF vs nanofat therapy in patients with primary knee OA.

Conducted at Mother Cell Regenerative Centre, Trichy, over 18 months (June 2025 to December 2026), the study will enroll 30 patients, randomly assigned to two groups of 15 each. Both interventions will be administered as a single intra-articular injection under sterile conditions, with cell viability (> 85%) confirmed by a standardized assay. Group A will receive autologous SVF injections, while Group B will receive autologous nanofat injections. The primary outcome measure is the change in pain scores at 12 months using the visual analog scale (VAS). Secondary outcomes include functional improvement assessed by Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities (WOMAC), and International Knee Documentation Committee (IKDC) scores, cartilage regeneration evaluated via magnetic resonance imaging with colour coded mapping of the cartilage volume (MR cartigram), and monitoring of adverse events.

This study aims to evaluate pain reduction at 12 months post-injection, using the VAS as the primary outcome. Secondary outcomes include functional improvement (KOOS, WOMAC, IKDC), cartilage regeneration (T2 cartigram), adverse event incidence, patient satisfaction (standardized questionnaires, Likert scale), and quality of life (EQ-5D). Ethical considerations follow the Declaration of Helsinki and Good Clinical Practice, with IRB approval and participant informed consent ensured. Confidentiality and data security comply with regulations, and a Data Safety Monitoring Board oversees trial safety. Results will be shared via peer-reviewed journals, presentations at international orthopedic conferences, and detailed summaries for stakeholders and participants. The trial is registered under CTRI/2024/03/064076. Findings emphasize patient-centered advancements in knee osteoarthritis management.

This trial evaluates the efficacy and safety of SVF and nanofat therapies in knee OA, addressing a significant evidence gap. It employs robust methods to enhance cartilage repair and patient quality of life. Future research should standardize dosages, protocols, and injection techniques, explore autologous/allogenic preparations, and advance radiological tools, broadening accessibility and clinical applications.