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The American Journal of Sports MedicineClinical Efficacy and Safety of the Intra-articular Injection of Autologous Adipose-Derived Mesenchymal Stem Cells for Knee Osteoarthritis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial

ADMSCs’ clinical efficacy and safety have been documented, however the treatment is still debatable because prior research used small sample sizes and diverse osteoarthritis grades.

The effectiveness and safety of using autologous culture-expanded adipose-derived mesenchymal stem cells (ADMSCs) to treat knee osteoarthritis are examined in this article. A randomized controlled experiment was used to compare the intra-articular injection of ADMSCs to a placebo.

Key Points:

  • A double-blind randomized controlled phase III trial with 261 Kellgren-Lawrence (K-L) grade 3 knee osteoarthritis patients was carried out.
  • Participants received either an intra-articular injection of autologous culture-expanded ADMSCs or a placebo.
  • The main outcomes were measured using the 100-mm visual analog scale (VAS) for pain and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for function, assessed at baseline, 3 months, and 6 months post-injection.
  • Six months post-injection, the ADMSC group showed significantly better improvements in VAS (25.2 vs 15.5; P = .004) and total WOMAC score (21.7 vs 14.3; P = .002) compared to the placebo group.

Additional Points:

  • Radiologic outcomes and adverse events did not display notable differences between the groups.
  • Magnetic resonance imaging showed no significant change in cartilage defects in either group at 6 months.
  • No serious treatment-related adverse events were observed.


  • Intra-articular injection of ADMSCs significantly improved pain and function in patients with K-L grade 3 knee osteoarthritis. However, the study calls for long-term results to assess potential disease-modifying effects and the duration of ADMSCs’ effectiveness.

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Did You Know?
According to the Arthritis Foundation, osteoarthritis affects over 32.5 million adults in the United States.

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