Abstract
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 (n = 37) or bilateral (n = 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 (p < 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 (p = 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.
Highlights
Osteoarthritis (OA) is the most prevalent joint disease in the United States with 38–47% of people older than 60 years affected by knee OA [1,2]
From March 2017 to January 2019, subjects were assessed for study eligibility according to the following inclusion criteria: primary or secondary uni- or bilateral symptomatic knee OA evidenced by radiographs or magnetic resonance imaging (MRI), failure of at least one conservative treatment for 3 months, age 25–80 years and willing to comply with study requirements
Sixty-four subjects were included in the study and the index knee was treated with a single injection of autologous micro-fragmented adiposetissue (MFAT) prepared with the Lipogem® device (Figure 2)
Summary
Osteoarthritis (OA) is the most prevalent joint disease in the United States with 38–47% of people older than 60 years affected by knee OA [1,2]. Over half of the persons suffering from symptomatic knee OA are younger than 65 years and experience significant disabilities on a daily basis [3] These numbers are only expected to increase due to an aging population and regrettable obesity numbers [1,4]. In patients who remain unresponsive, intraarticular injection therapies such as corticosteroids, hyaluronic acid (HA), platelet-rich plasma (PRP) or mesenchymal stromal cells (MSCs) are considered [2]. The latter option is nowadays thoroughly explored in all facets, while PRP reviews and RCTs with HA are showing contradictory outcomes due to the lack of high-level clinical evidence [2,6]. The recruitment of (autologous) MSCs to combat OA symptomatology is truly deserving of the necessary research attention in an attempt to expand the clinical toolbox of conservative, minimally invasive OA therapeutics
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