Autologous adipose-derived vascular stromal component injection offers a safe and effective method for treating knee osteoarthritis: A one-year double-blind, randomized controlled clinical trial

Abstract Background: Currently, conservative treatment for knee osteoarthritis (KOA) has limited efficacy, and autologous adipose-derived stromal vascular fraction (SVF) knee injections as a novel treatment approach are receiving widespread attention. Our study aimed to explore the efficacy and safety of SVF treatment for KOA patients. Methods: This double-blind, randomized controlled trial recruited unilateral KOA patients from the Rehabilitation Departments of the First, Second, and Third Affiliated Hospitals of Gannan Medical University. Sixty-six unilateral KOA participants were randomly divided into three groups for conventional treatment, SVF treatment, and a combination of SVF and conventional treatment. We compared the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, Visual Analogue Scale (VAS) scores, range of motion (ROM) of the knee, cartilage degeneration situation, and the incidence, nature, and severity of adverse events after treatment at 7 days, 1 month, 6 months, and 12 months. Results: A total of 62 patients completed the follow-up. There were no significant baseline differences among the groups. Our results demonstrated that, compared to baseline values, average VAS and WOMAC scores significantly decreased, while ROM significantly increased in the SVF and combination treatment groups during the 12-month follow-up, with a significant difference when compared to the control group ( P < 0.05). Cartilage regeneration was observed in the combination treatment group at the 12-month follow-up ( P < 0.05). No serious adverse events were observed during the 12-month follow-up, and no significant difference was noted in the incidence of complications among the three groups (P > 0.05). Conclusion: A single SVF injection demonstrates good safety, no serious adverse reactions, and can achieve better therapeutic effects when combined with conventional treatment, which is worth further investigation and promotion in clinical practice. Trial registration Chinese Clinical Trial Registry (ChiCTR2300074894). First trial registration in the format 18/08/2023