Lamo-Espinosa José María, Suárez-López Del Amo Álvaro, Núñez-Córdoba Jorge María, Blanco Juan F, Sánchez Mikel, Moreno Victoria, Cabrera Marta, Granero-Moltó Froilán, Muiños Emma, Mazo Manuel M, Crespo-Cullell Íñigo, Mora Gonzalo, Delgado Diego, Pompei-Fernández Orlando, Aquerreta Jesús Dámaso, Sola María Vitoria, Valentí-Azcárate Andrés, Andreu Enrique J, López-Parra Miriam, Villarón Eva M, Valentí-Nin Juan Ramón, Sánchez-Guijo Fermín, Prósper Felipe
Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008 Pamplona, Spain.
Cell Therapy Area, Clínica Universidad de Navarra, Regenerative Medicine Program, Cima Universidad de Navarra and Instituto de Investigación Sanitaria de Navarra (Idisna), 31008 Pamplona, Spain.
Diagnostics (Basel). 2025 Jan 28;15(3):309. doi: 10.3390/diagnostics15030309.
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 BM-MSCs in the treatment of knee OA. 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). : Of the 34 patients included in the study, 24 had received 100 × 10 BM-MSCs plus PRP and 10 had received 100 × 10 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 ( = 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 BM-MSCs plus HA (β-coefficient: -12.61; 95% CI: -19.71, -5.52) than with BM-MSC plus PRP ( = 0.001). 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.
骨髓间充质干细胞(BM-MSC)疗法已成为膝关节骨关节炎(OA)患者一种安全可行的治疗选择。然而,辅助剂的作用仍不明确。我们的目的是评估透明质酸(HA)与富血小板血浆(PRP)作为100×10 BM-MSCs治疗膝关节OA辅助剂的临床和放射学效果。我们使用了两项随机、平行组和对照临床试验的数据,这两项试验测试了BM-MSC的疗效,此前分别于2016年(ClinicalTrials.gov标识符NCT02123368,欧盟临床试验注册号:2009-017624-72)和2020年(ClinicalTrials.gov标识符NCT02365142,欧盟临床试验注册号:2011-006036-23)发表。在纳入研究的34例患者中,24例接受了100×10 BM-MSCs加PRP治疗,10例接受了100×10 BM-MSCs加HA治疗。平均而言,BM-MSC加HA在疼痛视觉模拟评分(VAS)上的改善程度高于BM-MSC加PRP(β系数:-1.25;95%置信区间(95%CI):-2.20至-0.30)(P = 0.01)。我们还观察到,与BM-MSC加PRP相比,BM-MSC加HA在WOMAC所有子量表评分和WOMAC总分上的改善更大,尽管这些差异无统计学意义。12个月时,100×10 BM-MSCs加HA的全器官磁共振成像评分(WORMS)比BM-MSC加PRP更有益(β系数:-12.61;95%CI:-19.71,-5.52)(P = 0.001)。BM-MSC治疗膝关节OA后的临床和放射学结果可能因所采用的辅助剂而异。作为辅助剂,HA比PRP显示出更大的临床疗效和更少的关节退变情况。