Abstract:Objective: To systematically evaluate the efficacy and safety of autologous stem cell transplantation combined with percutaneous transluminal angioplasty (PTA) in treatment of diabetic foot or limb ischemia. Methods: The literature of clinical controlled trials (CCTs) concerning autologous stem cell transplantation combined with PTA in treatment of diabetic foot or limb ischemia was collected by searching several national and international databases. The search included all articles from the inception of the databases until November 2017. After literature screening by two reviewers according to the quality assessment methods and inclusion/exclusion criteria, and then data extraction and assessment of risk of the included studies, Meta-analysis was performed by using Revman 5.3 software. Results: Twelve CCTs were finally included involving 630 patients with diabetic foot or limb ischemia. Meta-analysis showed that in patients undergoing autologous stem cell transplantation combined with PTA compared with those undergoing PTA alone, the ankle brachial index (MD=0.07, 95% CI=0.02–0.13, P=0.01), transcutaneous oxygen tension (MD=4.03, 95% CI=2.94–5.12, P<0.00001), cold sensation of the diseased limb (RR=1.29, 95% CI=1.14–1.45, P<0.0001), claudication distance (MD=372.89, 95% CI=108.97–636.81, P=0.006) and effectiveness evaluation (RR=1.18, 95% CI=1.08–1.29, P=0.0004) were all significantly improved. Conclusion: Autologous stem cell transplantation combined with PTA is superior in efficacy to PTA alone in treatment of diabetic foot or limb ischemia, with better safety. However, the conclusions still need to be supported by large multicenter randomized clinical trials.