Clinical Efficacy Of Intra-articular Mesenchymal Stem Cells For The Treatment Of Knee Osteoarthritis: A Double Blinded, Prospective, Randomized, Controlled Clinical Trial

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Objectives: Currently, there are limited non-operative treatment options available for knee osteoarthritis (OA). Stem cell based therapies have emerged as promising non-operative treatments for knee OA. Various stem cell mediums have been investigated, but there are limited prospective, randomized controlled trials for any of these therapies. This study aimed to investigate the 6 month and 1 year efficacy of intra-articular injections of autologous stromal vascular fraction stem cell therapy (SVF) in a double blinded, prospective, randomized, placebo controlled trial. Methods: This was a multi-site prospective, randomized, double-blinded clinical trial. Adult patients with symptomatic knee OA were eligible for enrollment. Patients were randomized to high dose SVF injection (3.0×107 SVF cells), low dose SVF injection (1.5×107 SVF cells), or placebo injection (zero SVF cells) in a 1:1:1 fashion. SVF was obtained via liposuction, which was then processed and injected during the same clinic visit. Knee function was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. MRIs were reviewed for changes in the cartilage thickness of chondral lesions. WOMAC scores and MRIs were obtained before injection, and at 6 and 12 months post-injection. The Wilcoxon Rank Sum non-parametric test was utilized to assess statistical significance and the Hodges

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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