Intra-Articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo-Controlled Clinical Trial
Intra-Articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo-Controlled Clinical Trial
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DOI：
10.1002/sctm.18-0122
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发表时间：
2019-06-01
影响因子：
6
通讯作者：
Jin, Wook
中科院分区：
文献类型：
--
作者：
Lee, Woo-Suk;Kim, Hwan Jin;Jin, Wook
间充质干细胞（MSC）一直是骨关节炎新兴治疗的焦点。然而，很少有研究报道关节内注射自体脂肪间充质干细胞（AD-MSC）的结果。本研究旨在评估单次关节内注射 AD-MSCs 对膝骨关节炎患者的疗效和安全性。这是一项前瞻性双盲、随机对照、IIb 期临床试验。 12例患者（MSC组）接受AD-MSCs治疗，并与注射生理盐水的12个膝关节（对照组）进行长达6个月的比较。所有手术均在门诊进行。主要结果指标是西安大略大学和麦克马斯特大学骨关节炎指数 (WOMAC) 评分。次要结果指标包括各种临床和放射学检查以及注射后的安全性。使用磁共振成像（MRI）评估注射后软骨缺损的变化。单次注射 AD-MSCs 导致 6 个月时 WOMAC 评分显着改善。在对照组中，6个月时WOMAC评分没有显着变化。随访期间两组均未观察到严重不良事件。 MRI显示，MSC组6个月时软骨缺损无明显变化，而对照组软骨缺损有所增加。关节内注射自体 AD-MSC 为门诊膝骨关节炎患者提供了令人满意的功能改善和疼痛缓解，并且在 6 个月的随访中未引起不良事件。需要更大的样本量和长期的随访。干细胞转化医学 2019；8:504-511
Mesenchymal stem cells (MSCs) have been the focus of an emerging treatment for osteoarthritis. However, few studies reported about outcomes of an intra-articular injection of autologous adipose-derived mesenchymal stem cells (AD-MSCs). This study aimed to assess the efficacy and safety of a single intra-articular injection of AD-MSCs for patients with knee osteoarthritis. It was a prospective double-blinded, randomized controlled, phase IIb clinical trial. AD-MSCs were administered for 12 patients (MSC group), and the group was compared with 12 knees with injection of normal saline (control group) up to 6 months. All procedures were performed in the outpatient clinic. Primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score. Secondary outcome measure included various clinical and radiologic examination, and safety after injection. Change of cartilage defect after injection was evaluated using magnetic resonance imaging (MRI). Single injection of AD-MSCs led to a significant improvement of the WOMAC score at 6 months. In the control group, there was no significant change in the WOMAC score at 6 months. No serious adverse events were observed in both groups during the follow-up period. In MRI, there was no significant change of cartilage defect at 6 months in MSC group whereas the defect in the control group was increased. An intra-articular injection of autologous AD-MSCs provided satisfactory functional improvement and pain relief for patients with knee osteoarthritis in the outpatient setting, without causing adverse events at 6 months' follow-up. Larger sample size and long-term follow-up are required. Stem Cells Translational Medicine 2019;8:504-511