Treatment of knee osteoarthritis with intra-articular injection of autologous adipose-derived mesenchymal progenitor cells: a prospective, randomized, double-blind, active-controlled, phase IIb clinical trial
Treatment of knee osteoarthritis with intra-articular injection of autologous adipose-derived mesenchymal progenitor cells: a prospective, randomized, double-blind, active-controlled, phase IIb clinical trial
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关节内注射自体脂肪间充质祖细胞治疗膝骨关节炎：一项前瞻性、随机、双盲、主动对照 IIb 期临床试验
DOI：
10.1186/s13287-019-1248-3
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发表时间：
2019-05-21
影响因子：
7.5
通讯作者：
Bao, Chunde
中科院分区：
文献类型：
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作者：
Lu, Liangjing;Dai, Chengxiang;Bao, Chunde
目的人脂肪间充质祖细胞（haMPCs）是具有多种分化潜能和免疫调节功能的干细胞。 Re-Join (R) 包含来自患者脂肪组织的体外扩增 haMPC 与细胞悬浮液的组合。本研究旨在评估 Re-Join (R) 对有症状的膝骨关节炎 (OA) 患者的疗效和安全性。方法从两个中心招募 Kellgren-Lawrence 1-3 级膝 OA 患者，并随机接受关节内注射 Re-Join (R) 或 HA。使用 WOMAC 评分、VAS 和 SF-36 评估疼痛和功能。进行磁共振成像（MRI）分析来测量软骨修复情况。收集不良事件 (AE)。结果 53 名患者被随机分组。与基线相比，第 6 个月和第 12 个月两组的 WOMAC、VAS 和 SF-36 评分均出现显着改善。与HA组相比，12个月后，WOMAC改善50%的患者明显增多，并且Re-Join(R)组有70%改善率的患者增多的趋势。同时，通过MRI测量，12个月后Re-Join（R）组的双膝关节软骨体积比HA组明显增加。两组之间的 AE 具有可比性。 HA 组中除 1 例右膝关节感染 SAE 外，大多数 AE 均为轻度和中度。结论：在 12 个月的时间内，接受 Re-Join (R) 治疗的膝关节 OA 患者观察到关节功能、疼痛、生活质量和软骨再生显着改善，且耐受性良好。试验注册ClinicalTrials.gov 标识符：NCT02162693。 2014 年 6 月 13 日注册。
ObjectiveHuman adipose-derived mesenchymal progenitor cells (haMPCs) are stem cells with multiple differentiation potential and immunomodulatory function. Re-Join (R) comprises in vitro expanded haMPCs from adipose tissue of patients combined with cell suspension solution. This study was undertaken to evaluate the efficacy and safety of Re-Join (R) in patients with symptomatic knee osteoarthritis (OA).MethodsPatients with Kellgren-Lawrence grade 1-3 knee OA were recruited from two centers and randomized to receive intra-articular injection of Re-Join (R) or HA. Pain and function were assessed by using WOMAC score, VAS, and SF-36. Magnetic resonance imaging (MRI) analysis was performed to measure cartilage repair. Adverse events (AEs) were collected.ResultsFifty-three patients were randomized. Significant improvements in WOMAC, VAS, and SF-36 scores were observed in both groups at months 6 and 12 compared with baseline. Compared with the HA group, significantly more patients achieved 50% improvement of WOMAC and a trend of more patients achieved a 70% improvement rate in Re-Join (R) group after 12months. Meanwhile, there was notably more increase in articular cartilage volume of both knees in the Re-Join (R) group than in the HA group after 12months as measured by MRI. AEs were comparable between two groups. Most AEs were mild and moderate except one SAE of right knee joint infection in the HA group.ConclusionsSignificant improvements in joint function, pain, quality of life, and cartilage regeneration were observed in Re-Join (R)-treated knee OA patients with good tolerance in a period of 12months.Trial registrationClinicalTrials.gov Identifier: NCT02162693. Registered 13 June 2014.