SVF
Level A· Stronger Clinical EvidenceRandomized Controlled Trial

Adipose tissue-derived versus bone marrow-derived cell concentrates for the injective treatment of knee osteoarthritis: protocol of a prospective randomised controlled trial.

Andriolo L., Veronesi F., Zanasi L., Costa V., Franceschini M., Miceli M.

Randomized Controlled Trial with a reported sample of 204 on Knee Osteoarthritis, Osteoarthritis, Chronic Inflammation, published in BMJ Open (2025) — summary generated from the PubMed abstract.

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Randomized Controlled Trial
Journal
BMJ Open (2025)
Country
England
Reported sample size
204
PMID
40306987
DOI
10.1136/bmjopen-2024-092379
NCT
NCT06040957

Abstract (original English)

Intra-articular injections of mesenchymal stromal cells concentrates showed promising results in the treatment of knee osteoarthritis (OA). Among these, bone marrow aspirate concentrate (BMAC) has been widely adopted in clinical practice. More recently, microfragmented adipose tissue (MFAT) has been proposed as a more suitable solution. However, there is still no high-level evidence demonstrating the superiority of MFAT to BMAC. The aim of this randomised controlled trial is to compare the safety and clinical outcomes of a single intra-articular injection of BMAC versus a single intra-articular injection of MFAT in patients with knee OA. 204 patients aged 40-75 years and affected by knee OA are randomised to receive a single injection of BMAC or MFAT in a 1:1 ratio. The primary outcome of the study is the Western Ontario and McMaster University OA index (WOMAC) pain score at 6 months. The secondary outcomes of the study are the WOMAC pain score at 2 months and 12 months and the WOMAC subscales, the total WOMAC score, the International Knee Documentation Committee subjective and objective scores, the Knee Injury and OA Outcome score, the visual analogue scale (VAS) for pain evaluation, the EuroQol VAS and the Tegner score at 2 months, 6 months and 12 months. Moreover, the study aims at demonstrating whether these products have disease-modifying effects: radiographs and magnetic

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

How we grade evidence
AdultAgedFemaleHumansMaleMiddle AgedAdipose TissueBone Marrow TransplantationInjections, Intra-ArticularMesenchymal Stem Cell Transplantation
KneeSystemic / IVKnee OsteoarthritisOsteoarthritisChronic Inflammation
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