Effect of Hyaluronic Acid Compared to Platelet-Rich Plasma as Adjuvants to Bone Marrow Mesenchymal Stem Cell Treatment of Knee Osteoarthritis: Analysis from Two Clinical Trials

透明质酸与富血小板血浆作为骨髓间充质干细胞治疗膝骨关节炎辅助疗法的疗效比较:两项临床试验的分析

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Abstract

Background: Bone marrow mesenchymal stem cell (BM-MSC) therapy has emerged as a safe and feasible treatment option for patients with knee osteoarthritis (OA). However, the role of adjuvants remains unclear. Our aim was to evaluate the clinical and radiological effects of hyaluronic acid (HA) in comparison to platelet-rich plasma (PRP) as adjuvants to 100 × 10(6) BM-MSCs in the treatment of knee OA. Methods: We used data from two randomized, parallel-group and controlled clinical trials which tested the efficacy of BM-MSC, previously published in 2016 (Clinical Trials.gov identifier NCT02123368, Nº EudraCT: 2009-017624-72) and 2020 (Clinical Trials.gov identifier NCT02365142. Nº EudraCT: 2011-006036-23). Results: Of the 34 patients included in the study, 24 had received 100 × 10(6) BM-MSCs plus PRP and 10 had received 100 × 10(6) BM-MSCs plus HA. On average, BM-MSC plus HA showed a higher improvement in VAS for pain [β-coefficient: -1.25; 95% confidence interval (95% CI):-2.20 to -0.30) than BM-MSC plus PRP (p = 0.01). We also observed that BM-MSC plus HA showed a greater improvement in all the WOMAC subscales scores and in the WOMAC overall score, compared to BM-MSC plus PRP, although these differences were not statistically significant. The Whole-Organ Magnetic Resonance Imaging Score (WORMS) at 12 months was more beneficial with 100 × 10(6) BM-MSCs plus HA (β-coefficient: -12.61; 95% CI: -19.71, -5.52) than with BM-MSC plus PRP (p = 0.001). Conclusions: The clinical and radiological outcomes after BM-MSC therapy for knee OA could differ according to the adjuvant employed. HA showed greater clinical effectiveness and fewer instances of articular degeneration than PRP as an adjuvant.

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