Effect of intra-articular adipose-derived mesenchymal stromal cell versus placebo injection on pain and function in patients with knee osteoarthritis: the ADIPOA2 phase 2b randomised 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)

This study aims to evaluate the efficacy of intra-articular autologous adipose-derived ex vivo expanded mesenchymal stromal cells (ADSC) on patient-reported outcome (pain and function) in symptomatic mild-to-moderate tibiofemoral knee osteoarthritis (OA). Participants were randomised in a prospective, double-blind, controlled phase 2b study to receive 1 single intra-articular injection in 3 separate groups: ADSC low dose 2 × 10 6 cells; ADSC high dose 10 × 10 6 cells; or saline placebo. The primary outcome was the rate of OsteoArthritis Research Society International (OARSI)/Outcome MEasures in Rheumatology (OMERACT) 'strict responders' defined by improvements from baseline reported to 0 to 100 mm scale in Western Ontario and McMaster University Osteoarthritis index (WOMAC) pain or physical function subscores ≥50% with minimal absolute changes ≥20 mm at 6 months. Secondary outcomes included an evaluation of WOMAC pain, WOMAC function, quality of life (36-Item Short Form Health Survey), WOMAC and Knee injury and OA Outcome Score global change, magnetic resonance imaging cartilage thickness changes and safety from baseline to 12-month follow-up. One hundred thirty-five patients were randomised from September 2016 to March 2022 (mean age, 58.3 [SD, 6.5] years; 58 [43%] women), 99 (73%) received allocated intervention, and 97 were analysed. After 6 months, treatment with ADSC versu

Evidence level

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

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