Van Genechten Wouter, Vuylsteke Kristien, Martinez Pedro Rojas, Swinnen Linus, Sas Kristof, Verdonk Peter
MoRe Institute, 2100 Antwerp, Belgium.
Department of Orthopaedic Surgery, Antwerp University, 2000 Antwerp, Belgium.
J Clin Med. 2021 May 21;10(11):2231. doi: 10.3390/jcm10112231.
The study aimed to evaluate the short-term clinical effect, therapeutic response rate (TRR%), and therapy safety of a single intra-articular autologous MFAT injection for symptomatic knee OA. Secondly, patient- and pathology-related parameters were investigated to tighten patient selection for MFAT therapy. Sixty-four subjects with symptomatic mild-severe knee OA were enrolled in a single-center trial and received a unilateral ( = 37) or bilateral ( = 27) MFAT injection. After liposuction, the adipose tissue was mechanically processed with the Lipogem device, which eventually produced 8-10 cc of MFAT. Subjects were clinically assessed by means of the KOOS, NRS, UCLA, and EQ-5D at baseline and 1, 3, 6, and 12 months after injection. Adverse events were recorded at each follow-up timepoint. The TRR was defined according to the OMERACT-OARSI criteria and baseline MRI was scored following the MOAKS classification. The TRR of the index knee was 64% at 3 months and 45% at 12 months after injection. Therapy responders at 12 months improved with 28.3 ± 11.4 on KOOS pain, while non-responders lost -2.1 ± 11.2 points. All clinical scores, except the UCLA, improved significantly at follow-up compared to baseline ( < 0.05). In the bilateral cohort, no difference in baseline scores or TRR was found between the index knee and contralateral knee (n.s.). An inflammatory reaction was reported in 79% of knees and resolved spontaneously within 16.6 ± 13.5 days after MFAT administration. Numerous bone marrow lesions (BML) were negatively correlated with the TRR at 12 months ( = 0.003). The study demonstrated an early clinical improvement but a mediocre response rate of 45% at 12 months after a single intra-articular injection with autologous MFAT. Assessment of bone marrow lesions on MRI can be helpful to increase the therapeutic responsiveness of MFAT up to 70% at 12 months. In comparison to repetitive injection therapies such as cortisone, hyaluronic acid, and PRP, administration of MFAT might become a relevant alternative in well-selected patients with symptomatic knee OA.
本研究旨在评估单次关节内自体脂肪源性基质血管成分（MFAT）注射治疗症状性膝关节骨关节炎（OA）的短期临床效果、治疗有效率（TRR%）及治疗安全性。其次，研究与患者及病理相关的参数，以优化MFAT治疗的患者选择。64例症状性轻至重度膝关节OA患者纳入一项单中心试验，接受单侧（n = 37）或双侧（n = 27）MFAT注射。抽脂后，使用Lipogem设备对脂肪组织进行机械处理，最终获得8 - 10 cc的MFAT。在基线及注射后1、3、6和12个月，通过膝关节损伤和骨关节炎疗效评分（KOOS）、数字评分量表（NRS）、加州大学洛杉矶分校（UCLA）评分及欧洲五维健康量表（EQ - 5D）对受试者进行临床评估。在每个随访时间点记录不良事件。根据骨关节炎研究学会国际工作组（OMERACT - OARSI）标准定义TRR，并按照膝关节骨关节炎磁共振成像（MOAKS）分类对基线MRI进行评分。注射后3个月时，指数膝关节的TRR为64%，12个月时为45%。12个月时治疗有效的患者KOOS疼痛评分改善了28.3±11.4分，而无效患者则下降了 - 2.1±11.2分。与基线相比，除UCLA评分外，所有临床评分在随访时均有显著改善（P < 0.05）。在双侧队列中，指数膝关节与对侧膝关节在基线评分或TRR方面未发现差异（无统计学意义）。79%的膝关节报告有炎症反应，在MFAT注射后16.6±13.5天内自发消退。大量骨髓损伤（BML）与12个月时的TRR呈负相关（P = 0.003）。该研究表明，单次关节内注射自体MFAT后早期有临床改善，但12个月时的有效率一般，为45%。MRI评估骨髓损伤有助于将MFAT在12个月时的治疗有效率提高至70%。与皮质类固醇、透明质酸和富血小板血浆（PRP）等重复注射疗法相比，对于精心挑选的症状性膝关节OA患者，MFAT注射可能成为一种有效的替代治疗方法。
