Efficacy and safety of adipose tissue-derived cell therapy in the treatment of chronic extremity ulcers: a systematic review and meta-analysis of randomized controlled trials

CONTEXT: Chronic extremity ulcers represent a major clinical challenge. Adipose-derived stem cells (ADSCs) have emerged as a promising therapeutic option for wound healing; however, their efficacy and safety remain incompletely established. OBJECTIVES: To evaluate the efficacy and safety of ADSCs compared with conventional treatment. METHODS: A systematic review and meta-analysis of 11 randomized clinical trials involving 474 patients was conducted. Outcomes included healing rate, mean healing time, pain-related outcomes, and safety. Odds ratios (ORs) and weighted mean differences were used as summary effect measures. RESULTS: Complete healing rates were significantly higher in the ADSC group than in the conventional treatment group (84.2% vs. 49.0%; OR 5.77; p < 0.00001). Healing time was reduced by 19.39 days on average in ADSC group (p = 0.0004). No statistically significant differences were observed regarding pain outcomes or complication rates (p = 0.22). CONCLUSION: ADSC therapy increased healing rates and shortened healing time in patients with chronic extremity ulcers, with no evidence of a significant increase in treatment-related risks. However, the heterogeneity of the findings and the limited sample size highlight the need for studies with greater statistical power and methodological standardization to confirm these results.