Jeyaraman Madhan, Karthik K S, Choudary Dinesh, Jeyaraman Naveen, Nallakumarasamy Arulkumar, Ramasubramian Swaminathan
Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu 600077 India.
Department of Orthopaedics, Faculty of Medicine-Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu 600095 India.
Indian J Orthop. 2024 Jun 7;58(8):1016-1026. doi: 10.1007/s43465-024-01194-4. eCollection 2024 Aug.
Anti-inflammatory and anti-fibrotic properties maximize the therapeutic potential of bone marrow aspiration concentrate (BMAC) in osteoarthritis (OA) knee. There is a lack of studies to standardize the treatment procedure to make the studies done across various centers comparable to understand the lacunae better and develop further the deficiency in our understanding of BMAC for OA knee. We aimed to assess the degree of pain relief, functional outcome, and cartilage thickness with different doses of BMAC in primary OA knee.
A single-centered prospective observational study was conducted with 80 patients of OA knee who were divided into 4 groups where group A ( = 20), group B ( = 20), group C ( = 20), and group D ( = 20) received intra-articular 1, 2, 5 million BMAC cells per kg body weight, and intra-articular saline, respectively. All patients were followed up with Visual Analog Scale (VAS), knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and International Knee Documentation Committee (IKDC) scores both pre and post-procedurally at 1, 3, 6, and 12 months follow-up.
The study found no significant differences in demographics or co-morbidities across four participant groups (A, B, C, D). However, clinical outcomes varied markedly: Groups B and C showed significant improvements in pain perception (VAS scores), knee function, and quality of life (KOOS and WOMAC scores), while Group A showed marginal or non-significant changes, and Group D exhibited no significant improvements. These findings suggest that treatments in Groups B and C reached the Minimal Clinically Important Difference, significantly enhancing patient-reported outcomes.
A dose of 2 million BMAC cells per kg body weight for knee OA serves as the better regenerative modality of choice in cartilage regeneration. With our dose-escalation study, we would be able to standardize the treatment procedure and enable global comparison of the treatment method across various regions of the world.
抗炎和抗纤维化特性使骨髓抽吸浓缩物（BMAC）在膝骨关节炎（OA）中的治疗潜力最大化。目前缺乏标准化治疗程序的研究，以使不同中心开展的研究具有可比性，从而更好地理解其中的不足，并进一步弥补我们对BMAC治疗膝OA认识上的缺陷。我们旨在评估不同剂量BMAC对原发性膝OA患者的疼痛缓解程度、功能结局和软骨厚度的影响。
对80例膝OA患者进行了单中心前瞻性观察研究，将其分为4组，A组（n = 20）、B组（n = 20）、C组（n = 20）和D组（n = 20），分别接受每千克体重100万、200万、500万BMAC细胞的关节腔内注射以及关节腔内注射生理盐水。所有患者在术前及术后1、3、6和12个月随访时，均采用视觉模拟评分法（VAS）、膝关节损伤和骨关节炎结局评分（KOOS）、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）以及国际膝关节文献委员会（IKDC）评分进行评估。
研究发现，四个参与组（A、B、C、D）在人口统计学或合并症方面无显著差异。然而，临床结局差异显著：B组和C组在疼痛感知（VAS评分）、膝关节功能和生活质量（KOOS和WOMAC评分）方面有显著改善，而A组变化不明显或无显著变化，D组则无显著改善。这些结果表明，B组和C组的治疗达到了最小临床重要差异，显著提高了患者报告的结局。
每千克体重200万BMAC细胞的剂量是膝OA软骨再生更好的再生治疗方式。通过我们的剂量递增研究，我们将能够标准化治疗程序，并使全球不同地区的治疗方法具有可比性。
