Stem Cell Treatment for Diabetic Foot Ulcers: A Meta-analysis of Randomized Clinical Trials

Abstract

ABSTRACTGENERAL PURPOSETo provide information on the efficacy of stem cells in the treatment of diabetic foot ulcers.TARGET AUDIENCEThis continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care.LEARNING OBJECTIVES/OUTCOMESAfter participating in this educational activity, the participant will: 1. Explain outcomes from the use of stem cell treatment for diabetic foot ulcers. 2. Identify features in the methodology of randomized controlled trials examining the efficacy of stem cells in the treatment of diabetic foot ulcers.OBJECTIVETo assess the efficacy of stem cells in the treatment of diabetic foot ulcers.DATA SOURCESThe authors searched PubMed, EMBASE, Cochrane Library, and Clinical Trials databases.STUDY SELECTIONThe preliminary search identified 343 articles. After screening, 16 articles reporting 19 randomized controlled trials were included in the meta-analysis.DATA EXTRACTIONThe 16 articles included a total of 766 patients (400 in stem cell groups, 366 in control groups). Extracted data included: first author, publication date, patient characteristics, ulcer size, stem cell type and dose, follow-up time, evaluation index (eg, cure rate, amputation rate, pain-free walking distance), and adverse events.DATA SYNTHESISThe stem cell group had a higher ulcer healing rate compared with the control group (odds ratio [OR], 5.16; 95% CI, 3.60–7.40;P< .00001); the mesenchymal stem cell and mononuclear cell groups had higher ulcer healing rates (OR, 3.98; 95% CI, 2.05–7.73;P< .0001; and OR, 12.85; 95% CI, 4.36–37.82;P< .0001, respectively). Seven articles reported amputation rates, which were lower in the treatment group than the control group (OR, 0.18; 95% CI, 0.08–0.41;P< .0001). Pain-free walking distance increased more after treatment in the stem cell group (standardized mean difference, 1.27; 95% CI, 0.89–1.65;P< .00001). Although 14 articles reported 92 adverse events, there was no association between stem cell infusion and adverse events.CONCLUSIONSStem cell therapy is an effective treatment strategy that can improve patient symptoms.