What type of study is this?

This is a RCT study (also classified as: Phase 2).

September 10, 2025Open Access

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

Key Points

Intra-articular injections of adipose-derived stem cells did not significantly improve pain or function in knee osteoarthritis patients.
At six months, 47.3% of patients receiving ADSC reported improvements, compared to 54.8% in the placebo group, with no statistically significant difference.
This randomized clinical trial included 135 patients with knee osteoarthritis, evaluating improvements in pain and function after treatment versus placebo.
Findings suggest that intra-articular adipose-derived stem cell injections may not provide the anticipated benefits for treating knee osteoarthritis.

Abstract

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 × 106 cells; ADSC high dose 10 × 106 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 versus placebo injection, 26 patients (47.3%) versus 23 patients (54.8%) were strict OARSI/OMERACT responders (relative risk 0.86 95% CI: 0.58-1.28; P = .46). Individuals showed different patterns in cartilage thickness change between timepoints across tibiofemoral articular surfaces, but overall secondary outcomes showed no significant-group differences. Among patients with symptomatic mild-to-moderate knee OA, a single intra-articular injection of 2 × 106 or 10 × 106 autologous ADSC compared with injection of saline placebo did not significantly improve pain and function. ClinicalTrials.gov Identifier: NCT02838069, https://clinicaltrials.gov/study/NCT02838069/EudraCT number: 2015-002125-19, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-002125-19.

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