Efficacy and safety of stem cell therapy in patients with chronic lower extremity ulcers: an umbrella review of systematic reviews and meta-analyses

Dec 20, 2025Stem cell research & therapy

Effectiveness and safety of stem cell treatment for long-lasting leg wounds: a summary of reviews

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Abstract

A total of 28 systematic reviews and meta-analyses involving 72 randomized controlled trials highlight the potential therapeutic benefits of stem cell therapy for chronic lower extremity ulcers.

Stem cell therapy may improve healing rates for chronic lower extremity ulcers.
Benefits associated with stem cell therapy include better tissue blood flow and reduced pain.
No significant difference in overall mortality was observed between stem cell therapy and control groups.
Current evidence is limited by methodological flaws and variability among studies.

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BACKGROUND: Chronic lower extremity ulcers (CLEUs) remain a major clinical challenge due to their prolonged healing process and risk of amputation. Stem cell therapy (SCT) has emerged as a promising regenerative strategy, with various cell types being explored for their efficacy in treating CLEUs. This umbrella review aims to consolidate the existing evidence on stem cell interventions for CLEUs, providing a comprehensive overview of the current research landscape.

METHODS: This umbrella review was conducted following the PRIOR and PRISMA guidelines. We searched across PubMed, Embase, Web of Science, and Cochrane Library databases for systematic reviews (SRs) and meta-analyses (MAs) that included randomized controlled trials (RCTs) on SCT for CLEUs. The methodological quality and evidence quality of the SRs/MAs were assessed by AMSTAR 2 and GRADE. A quantitative synthesis of all RCTs included in the SRs/MAs to obtain objective and updated conclusions.

RESULTS: A total of 28 SRs/MAs involving 72 RCTs were included. Our updated meta-analysis reinforces that SCT offers potential therapeutic benefits for CLEUs, including improved healing rates, amelioration of tissue perfusion and pain-related indicators, and more favorable prognostic outcomes. No significant difference in all-cause mortality was observed between the SCT and control groups.

CONCLUSION: SCT represents a promising adjunctive therapy for CLEUs, with many studies demonstrating its safety and potential benefits. Since current evidence is limited by methodological flaws and study heterogeneity, high-quality RCTs in the future are crucial to prove the benefits of SCT for CLEUs truly.

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Efficacy and safety of stem cell therapy in patients with chronic lower extremity ulcers: an umbrella review of systematic reviews and meta-analyses

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