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
Primary result · OARSI/OMERACT strict respondersResult — go to the resultRelative risk 0.86 95% CI 0.58–1.28Authors' conclusion
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.
Study context
- Population
- Patients with symptomatic mild-to-moderate tibiofemoral knee osteoarthritis (OA)97 analysed
- Participants
- 135 patients
- Comparison
- Single intra-articular injection of autologous ADSC vs saline placebo
- Primary endpoint
- Rate of OsteoArthritis Research Society International (OARSI)/OMERACT 'strict responders': improvement from baseline in WOMAC pain or physical function subscores (0–100 mm) ≥50% with minimal absolute change ≥20 mm
- Follow-up
- 6 months
Methodological detailsphase 2b, prospective, double-blind, placebo-controlled, 99 (73%) received allocated intervention
- Phase 2b
- Prospective
- Double-blind
- Placebo-controlled
- 99 (73%) received allocated intervention
Primary result
OARSI/OMERACT strict responders
Relative risk
0.86
95% CI 0.58–1.28
P = 0.46
Events by treatment group
ADSC (low and high dose)vs Placebo
RR 0.86 (95% CI 0.58–1.28); P = 0.46
As reported in the abstract
Secondary outcomes
Secondary outcomes (WOMAC pain, WOMAC function, SF-36 QoL, WOMAC and KOOS global change, MRI cartilage thickness, safety) to 12 months
- Overall secondary outcomes showed no significant group differences
Original publication
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. Ann Rheum Dis. Published 29 August 2025. doi:10.
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