Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial

Abstract

Purpose Current conservative treatments for knee OA provide limited benefits, with symptoms relief for a short amount of time. Regenerative medicine approaches such as the use of microfragmented adipose tissue (mFAT) showed promising results in terms of durable effects and the possibility to enhance tissue healing and counteract the progression of the pathology. Nevertheless, up to today, the large part of clinical data about mFAT use refers to uncontrolled studies, especially in the surgical setting. The purpose of this study was to evaluate the effectiveness of mFAT applied in association with arthroscopic debridement (AD) for the treatment of knee OA, in terms of symptoms relief and tissue healing. Methods This study is a prospective, randomized controlled clinical trial. 78 patients affected by knee OA grade 3–4 according to KL classification were randomly assigned to AD or AD + mFAT treatment groups. Clinical, radiological and serological assessments were performed at 6 months after treatment. Additional clinical evaluation was performed at the end of the study with an average follow-up of 26.1 ± 9.5 months. VAS, KOOS, WOMAC and SF-12 were also collected at both timepoints, KSS only at 6 months. Results Treatment with AD + mFAT improved functional scores at both 6 months (KOOS-PS: + 11.7 ± 20.2 vs + 24.4 ± 22.5, in AD and AD + mFAT, respectively, p = 0.024; KSS: + 14.9 ± 15.9 vs + 24.8 ± 23.5, in AD and AD + mFAT, respectively, p = 0.046) and 24-month follow-ups (KOOS-PS Functional subscale: − 2.0 ± 3.5 vs − 4.7 ± 4.2, in AD and AD + mFAT, respectively, p = 0.012). Lower T2-mapping scores were obtained in AD + mFAT-treated group in medial and lateral condyle compartments (p < 0.001). Slight increase was observed in the levels of a serum biomarker of cartilage deposition (PIIINP) in both groups at 6-month follow-up (p = 0.037). Conclusion mFAT improves functional outcome and MRI appearance when used in association with AD, therefore supporting its use in the treatment of knee OA in an arthroscopic setting.

Adipose Tissue-Derived Minimally Manipulated Products versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Systematic Review of Clinical Evidence and Meta-Analysis

“…The mean BMI went from 24.7 [ 50 ] to > 35 [ 40 ] for MM-AT and from 26.0 [ 42 ] to 31.0 [ 29 ] for the control groups (12 studies did not report BMI). Patients presented different OA grades, often measured with KL classification: nine studies on KL 1–4 [ 28 , 29 , 39 , 44 , 45 , 46 , 54 , 56 , 59 ], eight studies on KL 3–4 [ 30 , 33 , 35 , 40 , 41 , 47 , 48 , 55 ], three studies on KL 2–3 [ 34 , 42 , 50 ], three studies on KL 1–3 [ 34 , 44 , 51 ], two studies on KL 1–2 [ 32 , 37 ], and two studies on KL 2–4 [ 36 , 53 ]. In addition, patients with mild, moderate, or severe OA grade [ 43 ], ICRS grade of 2–4 [ 51 , 52 ], and American College of Rheumatology criteria 1–3 [ 57 ] were also evaluated.…”

“…MM-AT injection was compared with other orthobiologic treatments, such as PRP (n = 5) [ 29 , 32 , 37 , 42 , 59 ] and BMAC (n = 2) [ 45 , 49 ]. Moreover, the augmentation of intra-articular MM-AT injections to surgical procedures was evaluated in three studies: augmentation to arthroscopic debridement (AD) (n = 2) [ 48 , 55 ] and augmentation to high tibial osteotomy (HTO) (n = 1) [ 44 ]. The other studies had no comparison group (n = 23).…”

“…Three studies analyzed the effects of the augmentation of intra-articular MM-AT injection to surgical treatments, like HTO [ 44 ] or AD [ 48 , 55 ]. The adjunct of an MM-AT injection after HTO significantly improved the clinical outcome in terms of KOOS daily-life assessment score at 12 months of follow-up compared to patients treated with HTO alone.…”

Intra-Articular Injection of Autologous Micro-Fragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: A Prospective Interventional Study

“…Some studies have shown that after intra-articular injection, MSCs attach to cartilage defects, increase in number and participate in the regeneration of articular cartilage [ 8 , 21 ]. Adipose tissue is an easily accessible source of MSCs, and its micro fractionation state MF-AT allows for rapid harvesting of relevant volumes of minimally manipulated tissue consisting of clusters containing MSCs [ 22 ]. Furthermore, compared to raw adipose tissue, MF-AT contains fewer leukocytes and supra-adventitial-adipose stromal cells, as well as abundant endothelial progenitor cells, which have been described to maintain proliferation and differentiation in interaction with tissue-resident cells [ 23 ].…”

Disease‐modifying effects of orthobiologics in the treatment of knee osteoarthritis: the lesson learned from preclinical research models

“…Minimally manipulated cell‐based products, such as those derived from adipose tissue (i.e. stromal vascular fraction, microfragmented adipose tissue) and bone marrow (bone marrow concentrate) are also reported to be effective in mild to moderate knee OA [5, 12, 14, 19], although evidence is less solid due to the relatively low quality of most studies. Still, despite the available literature, many physicians are critical in recognizing the potential of these therapies.…”