Background: Regenerative cell therapies, such as adipose-derived stromal vascular fraction (SVF), have been postulated as potential treatments for knee osteoarthritis (KOA). Objectives: To assess the efficacy and safety of SVF treatment against placebo and other standard therapies for treating KOA in adult patients. Design: A systematic review. Data sources and methods: We searched the following databases: MEDLINE via PubMed, Epistemonikos, PEDro, DynaMed, TripDatabase, Elsevier via Clinicalkey and Cochrane Controlled Trials Register. We included prospective interventional studies where treatment with SVF in adults with KOA was compared against placebo or other standard therapies, and results were objectively measured with at least one widely recognised osteoarthritis scale. Results: Among 266 studies published until May 2021, nine met our inclusion criteria. A total of 239 patients (274 knees) were included in our study. The follow-up ranged from 6 to 24 months. Six studies had a control group (only one being placebo). All studies showed that SVF improved pain and functionality measured, in most cases, with the visual analogue scale and the Western Ontario and McMaster Universities Osteoarthritis Index. In addition, five studies reported an improvement in anatomical structures, as detected in MR images. However, the number of cells contained in SVF varied substantially between different studies, which could induce a comparison bias. Conclusion: Although based on a small number of dissimilar studies, SVF was considered a safe treatment for KOA and could be promising in terms of pain, functionality and anatomical structure improvement. However, SVF products need to be standardised, the number of cells homogenised and the use of concomitant treatments reduced to establish proper comparisons. Registration: PROSPERO registration number: CRD42021284187.
Biologic therapies have a huge potential in orthopaedic conditions such as knee osteoarthritis (KOA). Recently, numerous reviews and meta-analyses have been published in the field of regenerative medicine. Unfortunately, the lack of biologic product standardization and the concomitant use of different therapies do not allow consistent conclusions on their efficacy. Among others, platelet-rich plasma (PRP), stromal vascular fraction (SVF), cultured bone marrow, and adipose tissue-derived mesenchymal stem cells are the ones extensively tested. Microfragmented adipose tissue (MF-AT) has risen as an alternative therapy that needs a minimal manipulation approach. The article by Zaffagnini and coworkers 10 has provided an interesting insight into the role of autologous MF-AT on KOA treatment. However, we would like to raise some concerns on the methods and conclusions of the study.MF-AT efficacy in KOA is not evidence based yet. MF-AT has not been found superior in terms of efficacy compared with similar treatments that need less manipulation. Randomized placebo-controlled trials are missing. To the best of our knowledge, Zaffagnini et al 10 have published 1 of the 3 existing randomized clinical trials that use MF-AT to treat KOA. 2,6,10 Dallo et al 2 found an improvement on functional scales in both groups (the one treated with MF-AT and the one treated with PRP and hyaluronic acid), without clear benefits in the experimental group. In their study, Peretti et al 6 did not find significant differences in their preliminary results comparing arthroscopy versus arthroscopy and MF-AT injection.Concerning objective outcomes, magnetic resonance imaging (MRI) performed by Zaffagnini et al 10 to evaluate KOA improvement or progression showed no differences after MF-AT injection. In contrast, as already stated in a recent systematic review, SVF has proven significant improvement not only in subjective outcomes but also in radiological findings in MRI between baseline and a 12-or 24-month control. 4,5,[7][8][9] Thus, MF-AT should not be considered the first-line biologic treatment for KOA. Among adipose-derived biological products, SVF should be considered first. A great cell population with a great amount of adipose stem cells that can rapidly differentiate into all mesodermal lines is only
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