Intra-articular Injection of Mesenchymal Stem Cells for the Treatment of Osteoarthritis of the Knee A 2-Year Follow-up Study
Intra-articular Injection of Mesenchymal Stem Cells for the Treatment of Osteoarthritis of the Knee A 2-Year Follow-up Study
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DOI：
10.1177/0363546517716641
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发表时间：
2017-10-01
影响因子：
4.8
通讯作者：
Yoon, Kang Sup
中科院分区：
文献类型：
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作者：
Hyunchul, Chris;Chai, Jee Won;Yoon, Kang Sup
背景：膝关节关节内注射间充质干细胞（MSCs）已显示出治疗骨关节炎（OA）全身性软骨丢失的潜力。然而，很少有临床和结构结果的中期报告。目的：在2年随访中评估关节内注射自体脂肪组织来源（AD） MSCs治疗膝关节OA的中期安全性和有效性。研究设计：队列研究；证据水平，3。方法：纳入18例膝关节OA患者（男3例，女15例，平均年龄61.8 ~ 6.6岁[范围，52 ~ 72岁]）。低、中、高剂量组患者分别在膝关节关节内注射1.0 × 10(7)、5.0 × 10(7)和1.0 × 10(8) AD MSCs。临床和结构评估采用了广泛使用的方法，包括西安大略和麦克马斯特大学骨关节炎指数（WOMAC），以及使用磁共振成像（MRI）测量软骨缺损的大小和深度、再生软骨的信号强度和软骨体积。结果：2年内无治疗相关不良事件发生。无论细胞剂量如何，关节内注射自体AD MSCs可改善膝关节功能（通过WOMAC、膝关节协会临床评分系统（KSS）、膝关节损伤和骨关节炎结局评分（oos）测量），并减轻膝关节疼痛（通过视觉模拟评分（VAS）测量），持续时间长达2年。但主要在高剂量组有统计学意义。低剂量组和中剂量组的临床结果在1年后趋于恶化，而高剂量组的临床结果在2年后趋于稳定。MRI评估的结构结果也显示了类似的趋势。结论：该研究确定了在2年的时间内向OA膝关节关节内注射AD msc的安全性和有效性，鼓励进行更大规模的随机临床试验。然而，这项研究也显示了对临床和结构结果持久性的潜在担忧，表明需要进一步的研究。
Background: The intra-articular injection of mesenchymal stem cells (MSCs) into the knee has shown a potential for the treatment of generalized cartilage loss in osteoarthritis (OA). However, there have been few midterm reports with clinical and structural outcomes.Purpose: To assess the midterm safety and efficacy of an intra-articular injection of autologous adipose tissue-derived (AD) MSCs for knee OA at 2-year follow-up.Study Design: Cohort study; Level of evidence, 3.Methods: Eighteen patients with OA of the knee were enrolled (3 male, 15 female; mean age, 61.8 6.6 years [range, 52-72 years]). Patients in the low-, medium-, and high-dose groups received an intra-articular injection of 1.0 x 10(7), 5.0 x 10(7), and 1.0 x 10(8) AD MSCs into the knee, respectively. Clinical and structural evaluations were performed with widely used methodologies including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and measurements of the size and depth of the cartilage defect, signal intensity of regenerated cartilage, and cartilage volume using magnetic resonance imaging (MRI).Results: There were no treatment-related adverse events during the 2-year period. An intra-articular injection of autologous AD MSCs improved knee function, as measured with the WOMAC, Knee Society clinical rating system (KSS), and Knee injury and Osteoarthritis Outcome Score (KOOS), and reduced knee pain, as measured with the visual analog scale (VAS), for up to 2 years regardless of the cell dosage. However, statistical significance was found mainly in the high-dose group. Clinical outcomes tended to deteriorate after 1 year in the low- and medium-dose groups, whereas those in the high-dose group plateaued until 2 years. The structural outcomes evaluated with MRI also showed similar trends.Conclusion: This study identified the safety and efficacy of an intra-articular injection of AD MSCs into the OA knee over 2 years, encouraging a larger randomized clinical trial. However, this study also showed potential concerns about the durability of clinical and structural outcomes, suggesting the need for further studies.