Muthu Sathish, Ramanathan Karthikraja, Alagar Yadav Sangilimuthu, Jha Saurabh Kumar, Ranjan Rajni
Department of Biotechnology, School of Engineering and Technology, Sharda University, Greater Noida, Uttar Pradesh 201310 India.
Department of Orthopaedics, Government Medical College, Dindigul, Tamil Nadu 624001 India.
Indian J Orthop. 2024 Jun 5;58(8):1001-1008. doi: 10.1007/s43465-024-01197-1. eCollection 2024 Aug.
Knee osteoarthritis (KOA), a chronic degenerative disease, significantly impairs quality of life due to pain and mobility limitations. Traditional treatments focus on symptom management without addressing the underlying disease progression, leading to a growing interest in regenerative medicine approaches. Bone marrow aspirate concentrate (BMAC), rich in mesenchymal stem cells and growth factors, has shown potential for cartilage repair and symptom relief in KOA. Despite promising outcomes, the optimal BMAC dosage for knee OA treatment remains undetermined. This study aims to evaluate the clinical efficacy and safety of varying BMAC dosages in knee OA treatment.
This prospective controlled dose-escalation study involved 75 patients with early-stage knee OA, categorized into three groups based on BMAC dosage administered 10 × 10 cells (low-dose group), 50 × 10 cells (medium-dose group), or 100 × 10 cells (high-dose group). All the patients underwent a single intra-articular injection of BMAC and were monitored over a year. The primary outcomes include Visual Analog Scale (VAS) for pain and the Knee Injury and Osteoarthritis Outcome Score (KOOS) for joint function recorded at baseline, 1, 3, 6, and 12 months post-intervention. Adverse events were also documented.
Significant clinical improvements in VAS and KOOS scores were noted across all groups at all time points compared to the baseline. However, these improvements did not significantly differ between dosage groups throughout the follow-up period. Adverse effects were minimal and primarily consisted of transient post-injection pain and effusion, with no dose-dependent increase in complications.
BMAC treatment for knee OA is safe and demonstrates potential for significant pain relief and functional improvement, irrespective of the dosage administered within the tested range. The lack of significant differences among varying dosages suggests a plateau in therapeutic efficacy beyond a certain threshold. Further research is necessary on the long-term outcomes to optimize the dosing strategy.
膝关节骨关节炎（KOA）是一种慢性退行性疾病，由于疼痛和活动受限，严重损害生活质量。传统治疗方法侧重于症状管理，而未解决潜在的疾病进展问题，这使得人们对再生医学方法的兴趣日益浓厚。富含间充质干细胞和生长因子的骨髓抽吸浓缩物（BMAC）已显示出在KOA软骨修复和症状缓解方面的潜力。尽管取得了令人鼓舞的结果，但用于膝关节OA治疗的最佳BMAC剂量仍未确定。本研究旨在评估不同BMAC剂量在膝关节OA治疗中的临床疗效和安全性。
这项前瞻性对照剂量递增研究纳入了75例早期膝关节OA患者，根据给予的BMAC剂量分为三组：10×10细胞（低剂量组）、50×10细胞（中剂量组）或100×10细胞（高剂量组）。所有患者均接受一次关节内注射BMAC，并进行为期一年的监测。主要结局包括干预前基线、干预后1、3、6和12个月记录的疼痛视觉模拟量表（VAS）和关节功能的膝关节损伤和骨关节炎结局评分（KOOS）。还记录了不良事件。
与基线相比，所有组在所有时间点的VAS和KOOS评分均有显著的临床改善。然而，在整个随访期间，剂量组之间的这些改善没有显著差异。不良反应极少，主要包括注射后短暂疼痛和积液，并发症无剂量依赖性增加。
BMAC治疗膝关节OA是安全的，并且无论在测试范围内给予何种剂量，都显示出显著缓解疼痛和改善功能的潜力。不同剂量之间缺乏显著差异表明，超过一定阈值后治疗效果趋于平稳。需要进一步研究长期结局以优化给药策略。
