Efficacy of a single intra-articular injection of mesenchymal stem cells for knee osteoarthritis: a dose-focused meta-analysis of randomized controlled trials

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

• 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)

Background Intra-articular injection of mesenchymal stem cells (MSCs) has emerged as a promising therapy for knee osteoarthritis (OA). However, uncertainty remains regarding the optimal cell dose for maximizing clinical benefit. This systematic review and meta-analysis aimed to evaluate the efficacy of MSC injections for knee OA and investigate the relationship between cell dose and treatment outcome. Methods A comprehensive literature search was conducted in PubMed and Scopus for randomized controlled trials (RCTs) published between 2015 and 2025. Eligible studies were RCTs that used intra-articular MSC injections for knee OA, and WOMAC scores were reported at baseline and 12-month follow-up. Standardized mean differences (SMDs) were pooled using a random-effects model. Subgroup analysis and meta-regression were performed to evaluate the effect of MSC dose on treatment outcomes. Results Eight treatment arms from six RCTs involving 300 patients were included. The pooled SMD in the WOMAC score at 12 months was -1.35 (95% CI: -1.97 to -0.74), indicating a moderate to large treatment effect. MSC doses of ≤ 25 million cells were associated with statistically significant improvement, while higher doses did not demonstrate additional benefit. Meta-regression confirmed no significant dose-response relationship. Heterogeneity was moderate (I2 = 49.8%). Conclusion Intra-articular MSC th

Evidence level

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

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