Real-world Evidence of Mesenchymal Stem Cell Therapy in Knee Osteoarthritis: A Large Prospective Two-Year Case Series

Objective: To evaluate the long-term safety and efficacy of adipose-derived mesenchymal stem cell (ADMSC) therapy in the treatment of knee osteoarthritis (OA). Methods: 329 participants with knee OA underwent intra-articular ADMSC therapy. Participants were followed up for 24 months and were separated based on radiological OA grade. Results: Treatment was well tolerated with no related serious adverse events. All participant groups reported clinically and statistically significant pain improvement. Clinical outcome was not influenced by patients' age or BMI. Conclusion: ADMSC therapy is an effective, safe and long-lasting treatment option for knee OA with the potential to delay total joint replacement. In addition to the observed clinical benefits, ADMSC therapy promises to reduce the global economic burden of OA. Trial registration number: ACTRN12617000638336.The aim of this study was to assess the benefit of stem cell therapy in the treatment of mild to severe knee osteoarthritis. A total of 329 study participants with painful knee osteoarthritis undertook stem cell therapy and were followed up for two years. Stem cell therapy was well tolerated and safe. Significant pain and functional improvement were observed in all of the participant groups including those with severe bone-on-bone osteoarthritis. Participants' age and weight did not influence the clinical outcome. This study shows that stem cell therapy is an effective, safe and long-lasting treatment for knee osteoarthritis and greatly reduces knee pain and improves the function of the knee. Stem cell therapy may delay or prevent knee replacement surgery and result in significant global health and economic benefit.