AOSSM/AANA Specialty Day 2020-Clinical Efficacy of Intra-Articular Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis_ A Double Blinded, Prospective, Randomized Controlled Clinical Trial

Clinical Efficacy of Intra-Articular Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis_ A Double Blinded, Prospective, Randomized Controlled Clinical Trial

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This multi-site, double-blinded, randomized, placebo-controlled clinical trial evaluated the efficacy and safety of intra-articular injections of stromal vascular fraction (SVF) cells—a mixture of adipose-derived mesenchymal stromal and progenitor cells—in patients with symptomatic moderate knee osteoarthritis (OA). Thirty-nine patients aged 40-75 with Kellgren-Lawrence grade 2-3 knee OA were randomized into three groups receiving either high-dose SVF (30 million cells), low-dose SVF (15 million cells), or placebo (no cells). SVF was collected, processed, and injected during a single clinic visit.<br /><br />Outcomes were assessed at baseline and at 6 weeks, 3 months, 6 months, and 12 months post-injection, using the WOMAC questionnaire to evaluate symptoms and MRI to assess cartilage thickness. Results showed a statistically significant, dose-dependent improvement in knee pain and function in both SVF groups compared to placebo at 6 and 12 months, exceeding the minimal clinically important difference (MCID). Notably, high-dose patients experienced the greatest symptomatic relief. However, MRI evaluations revealed no measurable changes in cartilage thickness at these time points.<br /><br />The procedure was well tolerated with minimal adverse effects; only one patient in the high-dose group experienced transient aseptic knee swelling, and there were no signs of heterotopic ossification or neoplastic growth. The study concluded that intra-articular SVF injection is a safe, one-visit treatment that significantly reduces knee OA symptoms over one year. Although SVF’s effects on cartilage repair remain unconfirmed, these findings suggest SVF injections may delay or serve as an alternative to total knee arthroplasty, which carries higher costs, rehabilitation time, and complication risks.<br /><br />In summary, SVF cell therapy represents a promising, minimally invasive, disease-modifying treatment option for knee OA, offering sustained symptom improvement with a favorable safety profile. Further research is needed to elucidate its impact on cartilage regeneration.

Keywords

stromal vascular fraction

SVF

knee osteoarthritis

intra-articular injection

randomized controlled trial

WOMAC questionnaire

cartilage thickness

dose-dependent efficacy

safety profile

minimally invasive treatment