Evaulation of intra-articular adipose derived mesenchymal stem cell therapy in the treatment of symptomatic knee osteoarthritis – a randomised controlled trial.

Abstract

Background & Aim Background Osteoarthritis is a degenerative condition and a leading cause of pain and disability world wide. Current medical treatments are aimed at symptomatic control and do not achieve disease modification. Surgical interventions including total joint arthroplasty can be unpredictable. Pre-clinical and early clinical trials have shown initial evidence of safety and efficacy of mesenchymal stem cell (MSC) therapies. Aim To evaluate the efficacy of autologous adipose derived mesenchymal stem cell (AdMSC) therapy on pain, function and disease modification in symptomatic knee osteoarthritis (OA). Methods, Results & Conclusion Methods 30 participants with symptomatic knee osteoarthritis were recruited via website and general practice advertisements. Eligibility criteria included radiological confirmed Grade II-III knee OA according to Kellgren Lawrence criteria, age ≥18, and a previous conservative management program. Exclusion criteria included a history of cancer, an atypical pain disorder and pregnancy. Subjects were randomised into 3 groups of 10 participants. The 2 treatment groups received intra-articular autologous AdMSC therapy consisting of either a single injection of 100 × 106 AdMSCs or two injections of 100 × 106 AdMSCs (baseline and again at 6 months). The control group continued conservative management. Participants were not blinded. Outcome measures were recorded over 12 months. Primary and secondary outcome measures: Primary outcome aims of this trial were pain and functional changes as measured by the numeric pain rating scale (NPRS), the Knee Injury and Osteoarthritis Outcome Score and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). A secondary objective was to assess structural change using the semi-quantitative MRI Osteoarthritis Knee Score (MOAKS). Results Participants in the treatment groups receiving a single or two injection protocol showed statistical and clinically significant pain and functional improvement in comparison to control at completion of follow-up at 12 months. Radiological analysis indicated modification of disease progression in both treatment groups with the two-injection protocol achieving the greatest effect. No serious AEs were observed. Conclusion Autologous AdMSC therapy resulted in significant improvements in pain and function and also resulted in structural stabilisation. AdMSC therapy appears to be a safe and effective therapy for symptomatic knee osteoarthritis and has the potential to prevent disease progression.