Efficacy of Stromal Vascular Fraction Treatment for Knee Osteoarthritis: A Single-Arm Experimental Trial

Abstract

Background/Objectives: Knee osteoarthritis (KOA) is a common pathology characterized by impaired joint cartilage. Mesenchymal stromal cell (MSC)-based treatments, such as stromal vascular fraction (SVF), are increasingly being used for their potential cartilage-generating capabilities; however, there is still insufficient evidence to confirm their effectiveness. The aim of the study was to assess the efficacy of SVF treatment in KOA in terms of pain relief. Methods: An experimental clinical trial was performed. We included adults with symptomatic KOA who attended Celular Clinic (Andorra). A laboratory-manufactured and standardized SVF product (Celstem (R)) was applied to selected patients. Clinical, functional, and radiological assessments using the visual analog scale, KOOS (Knee Injury and Osteoarthritis Outcome Score), SF-36 scale, and MOCART classification (Magnetic Resonance Observation of Cartilage Repair Tissue) were performed. Variables were compared before treatment and at one, six, and twelve months after treatment. Adverse effects were reported. Results: In total, 184 patients were included in the clinical trial, 78 of whom were finally analyzed. There were statistically significant differences in both resting and activity-related pain and in all KOOS subscales after SVF treatment (p < 0.001). The quality of life also showed significant changes (p = 0.021). No significant changes were observed in MOCART values. However, a positive association was found between MOCART and cell yield. Few adverse effects were reported. Conclusions: Our nonrandomized uncontrolled clinical trial showed that SVF treatment has promise to reduce pain in patients with KOA. Improvements in functionality and quality of life were also observed. Future randomized controlled trials regarding SVF versus placebo therapies will further clarify this potential.