Zhang Shengyang, Xu Huihui, He Bangjian, Fan Mengqiang, Xiao Miaomiao, Zhang Jingjing, Chen Di, Tong Peijian, Mao Qiang
Department of Orthopedics, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
Department of Orthopedics and Traumatology, Shaoxing Hospital of Traditional Chinese Medicine, Shaoxing, China.
Stem Cell Res Ther. 2022 Mar 12;13(1):105. doi: 10.1186/s13287-022-02788-1.
The short-term safety and efficacy of stromal vascular fraction (SVF) in treating knee osteoarthritis (KOA) have been extensively studied but the mid-term and long-term prognoses remain unknown.
126 KOA patients were recruited and randomly assigned to SVF group and hyaluronic acid (HA) group (control group). The scores of visual analogue scale (VAS) and the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) were assessed and compared between the two groups 1, 2, 3, and 5 years after treatment. The endpoint was defined as surgeries related to KOA or clinical scores exceeding the patient acceptable symptom state (PASS).
The VAS and WOMAC scores in the SVF group were significantly better than those in the HA group during the 5-year follow-up after treatment. The average responsive time to SVF treatment (61.52 months) was significantly longer than HA treatment (30.37 months). The adjusted Cox proportional hazards model showed that bone marrow lesion (BML) severity, body mass index (BMI) and treatment were independent risk factors and that the use of SVF reduced the risk of clinical failure by 2.602 times. The cartilage volume was reduced in both the SVF and control groups at 5 years but reduced less in the SVF group.
Up to 5 years after SVF treatment, acceptable clinical state was present for approximately 60% of patients. BML severity and BMI were independent predictors of the prognosis.
This study was retrospectively registered at Chinses Clinical Trial Registry with identifier ChiCTR2100052818 and was approved by ethics committee of the First Affiliated Hospital of Zhejiang Chinese Medical University, number 2013-X-063.
基质血管成分（SVF）治疗膝关节骨关节炎（KOA）的短期安全性和有效性已得到广泛研究，但中期和长期预后仍不清楚。
招募126例KOA患者，随机分为SVF组和透明质酸（HA）组（对照组）。在治疗后1、2、3和5年评估并比较两组的视觉模拟量表（VAS）评分和西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分。终点定义为与KOA相关的手术或临床评分超过患者可接受症状状态（PASS）。
治疗后5年随访期间，SVF组的VAS和WOMAC评分显著优于HA组。SVF治疗的平均反应时间（61.52个月）显著长于HA治疗（30.37个月）。调整后的Cox比例风险模型显示，骨髓病变（BML）严重程度、体重指数（BMI）和治疗是独立的风险因素，使用SVF可将临床失败风险降低2.602倍。5年时，SVF组和对照组的软骨体积均减少，但SVF组减少较少。
SVF治疗后长达5年，约60%的患者处于可接受的临床状态。BML严重程度和BMI是预后的独立预测因素。
本研究在中国临床试验注册中心进行回顾性注册，标识符为ChiCTR2100052818，并获得浙江中医药大学附属第一医院伦理委员会批准，批准号为2013-X-063。
