Effectiveness and safety of Stem cell therapy for Diabetic Foot: a meta-analysis update

Abstract:

Background: Diabetic foot (DF) is one of the most common and serious complications of diabetes mellitus (DM), which brings great psychological and economic pressure to patients. This study aimed to evaluate the efficacy of stem cells in the treatment of diabetic foot.

Methods: All relevant literatures in Cochrane, Embase, PubMed, Web of Science, China National Knowledge Infrastructure, and Wanfang databases were systematically searched for meta-analysis. The outcomes consisted of ulcer or wound healing rate, amputation rate, new vessels, ankle-brachial index (ABI), transcutaneous oxygen pressure (TcPO2), pain-free walking distance, and rest pain score. Dichotomous outcomes were described as risk ratios (RR) with 95% confidence intervals (CIs), while continuous data were presented as standardized mean differences (SMDs) with 95% CIs. Statistical analysis was performed with RevMan 5.3 software.

Results: A total of 14 studies with 683 participants were included in the meta-analysis. Meta-analysis showed that stem cell therapy was more effective than conventional therapy in terms of ulcer or wound healing rate [OR =8.20 (5.33, 12.62)], improvement of lower extremity ischemia(new vessels) [OR=16.48 (2.88, 94.18)], ABI [MD=0.13 (0.04, 0.08)], TcO2[MD=4.23 (1.82, 6.65)], pain-free walking distance [MD =220.79 (82.10, 359.48)], and rest pain score [MD =-1.94 (-2.50, -1.39)], while the amputation rate was significantly decreased [OR =0.19 (0.10, 0.36)].

Conclusions: The meta-analysis of the current studies has shown that stem cells are significantly more effective than traditional methods in the treatment of diabetic foot, and can improve the quality of life of patients after treatment. Future studies should conduct large-scale, randomized, double-blind, placebo-controlled, multicenter trials with high-quality long-term follow-up to demonstrate the most effective cell types and therapeutic parameters for the treatment of diabetic foot.