人脐带血间充质干细胞对膝关节骨关节炎的疗效及安全性分析

Clinical efficacy and safety evaluation of human umbilical cord blood mesenchymal stem cells for knee osteoarthritis

摘要:

目的 观察膝关节腔注射人脐带血间充质干细胞（hUC-MSCs）对膝关节骨关节炎的临床治疗效果。方法 选取2024年1月—2025年1月北京中医药大学东方医院秦皇岛医院收治的66例膝关节骨关节炎患者，采用随机数字表法分为对照组（膝关节腔内注射玻璃酸钠）、观察组（膝关节腔内注射hUC-MSCs），各33例。两组患者均完成12个月随访。比较两组患者治疗前、治疗后3个月、治疗后6个月、治疗后12个月的西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分、勒克勒指数（Lequesne）评分、Lysholm膝关节评分量表评分，记录两组患者治疗期间关节疼痛、关节肿胀、关节积液等不良反应的发生情况。结果 治疗后3、6、12个月，两组WOMAC评分与Lequesne评分均呈下降趋势，Lysholm评分呈上升趋势；观察组各时间点上述评分改善效果均优于对照组（P <0.05）。两组不良反应总发生率比较，差异无统计学意义（P >0.05）。所有不良反应经非甾体抗炎药对症处理后均得到缓解，未出现严重不良事件。结论 经膝关节腔注射hUC-MSCs，可明显改善膝关节骨关节炎患者关节功能，缓解关节疼痛与炎症表现；不良反应经对症处理后均好转，未出现严重不良事件，整体安全性可靠，具备较高的临床推广与应用价值。

Abstract:

Objective To evaluate the clinical efficacy and safety of intra-articular injection of human umbilical cord blood mesenchymal stem cells (hUC-MSCs) for knee osteoarthritis.Methods A total of 66 patients with knee osteoarthritis were enrolled between January 2024 and January 2025 and randomly divided into a control group and an observation group using a random number table method, with 33 patients in each group. The control group received intra-articular sodium hyaluronate injection, while the observation group received intra-articular hUC-MSCs injection. All patients completed 12 months of follow-up. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, and Lysholm knee scores were compared before treatment, and at 3, 6, and 12 months after treatment. Adverse events including joint pain, swelling, and effusion were recorded.Results At 3, 6, and 12 months after treatment, WOMAC and Lequesne scores showed a decreasing trend in both groups, while Lysholm scores showed an increasing trend. The improvement in the above scores was significantly better in the observation group than in the control group at all time points (all P < 0.05). There was no significant difference in the overall incidence of adverse reactions between the two groups (P > 0.05). All adverse reactions were relieved after symptomatic treatment with non-steroidal anti-inflammatory drugs, and no serious adverse events occurred.Conclusion Intra-articular injection of hUC-MSCs effectively improves knee function, relieves pain, and reduces inflammation in patients with knee osteoarthritis. The treatment demonstrates good safety with manageable adverse events and substantial clinical application value.