Autologous Stem Cell Therapy in Critical Limb Ischemia: A Meta-Analysis of Randomized Controlled Trials.

ABSTRACT

OBJECTIVE: Critical limb ischemia (CLI) is the most dangerous stage of peripheral artery disease (PAD). Many basic researches and clinical treatment had been focused on stem cell transplantation for CLI. This systematic review was performed to review evidence for safety and efficacy of autologous stem cell therapy in CLI. METHODS: A systematic literature search was performed in the SinoMed, PubMed, Embase, ClinicalTrials.gov, and Cochrane Controlled Trials Register databases from building database to January 2018. RESULTS: Meta-analysis showed that cell therapy significantly increased the probability of ulcer healing (RR = 1.73, 95% CI = 1.45-2.06), angiogenesis (RR = 5.91, 95% CI = 2.49-14.02), and reduced the amputation rates (RR = 0.59, 95% CI = 0.46-0.76). Ankle-brachial index (ABI) (MD = 0.13, 95% CI = 0.11-0.15), TcO2 (MD = 12.22, 95% CI = 5.03-19.41), and pain-free walking distance (MD = 144.84, 95% CI = 53.03-236.66) were significantly better in the cell therapy group than in the control group (P < 0.01). CONCLUSIONS: The results of this meta-analysis indicate that autologous stem cell therapy is safe and effective in CLI. However, higher quality and larger RCTs are required for further investigation to support clinical application of stem cell transplantation.