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Autologous cell therapy improved healing rates and reduced ulcer area in patients with diabetic foot ulcers compared to control.

Autologous cell therapy improved healing rates and reduced ulcer area in patients with diabetic foot…
Photo by Nathan Rimoux / Unsplash
Key Takeaway
Note that autologous cell therapy showed improved healing in diabetic foot ulcers, but safety data were not reported.

This meta-analysis and systematic review assessed the efficacy of autologous cell therapy for treating diabetic foot ulcers. The analysis pooled data from studies involving 2,214 patients, comparing autologous cell therapy against a control group. The review did not report the specific study phases, settings, or follow-up durations for the individual trials included in the synthesis.

Regarding primary outcomes, the autologous cell therapy group demonstrated a significantly higher complete healing rate compared to the control group. The relative risk was 0.54 with a 95% confidence interval of 0.45. Additionally, the therapy group showed a significantly greater reduction in ulcer area, with a mean difference of 24.6% and a 95% CI of 18.3% to 30.9% (P < 0.05).

Safety and tolerability data were not reported for adverse events, serious adverse events, discontinuations, or general tolerability in the review. Consequently, the safety profile of autologous cell therapy in this context remains undefined based on this evidence. The review did not provide information regarding funding sources, conflicts of interest, or specific limitations of the included studies.

While the results suggest potential benefits for complete healing and area reduction, the absence of safety reporting and the aggregated nature of the data limit direct clinical application. Clinicians should weigh these efficacy signals against the unknown safety profile and the lack of detailed study characteristics before considering this intervention for diabetic foot ulcers.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedApr 2026
View Original Abstract ↓
BackgroundDiabetic foot ulcers are a common and serious complication in diabetic patients, and traditional treatments have limited healing rates. Autologous cells and related products, as an emerging therapy, require systematic evaluation for their efficacy and safety.ObjectiveTo systematically evaluate and meta-analyze the efficacy and safety of autologous cells and related products in the treatment of diabetic foot ulcers.MethodsRelevant randomized controlled trials up to November 2025 were searched in PubMed and Embase databases. Patients with diabetic foot ulcers were included, and the intervention was autologous cell therapy. Data on healing rate, percentage reduction in ulcer area, and healing days were extracted and meta-analyzed using RevMan 5.3.ResultsA total of 26 randomized controlled trials (RCTs) involving 2,214 patients were included. The autologous cell therapy group showed a significantly higher rate of complete healing than the control group (RR = 0.54, 95% CI: 0.45). The difference in ulcer area reduction was significantly greater (MD = 24.6%, 95%CI: 18.3-30.9, P
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