Gene therapy and cell-based therapy have emerged as novel therapies to promote therapeutic angiogenesis in critical limb ischemia\n(CLI) caused by peripheral artery disease (PAD). Although researchers initially focused on gene therapy using proangiogenic\nfactors, such as vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and hepatocyte growth factors (HGF),\ncell therapy using bone marrow mononuclear cells (BMMNCs), mesenchymal stem cells (BMMSCs), G-CSF-mobilized peripheral\nblood mononuclear cells (M-PBMNCs), and endothelial progenitor cells (EPCs) have also been extensively studied. Based on\nthe elaborate studies and favorable results of basic research, some clinical phase I/II trials have been performed, and the results\ndemonstrate the safety of these approaches and their potential for symptomatic improvement in CLI. However, the phase 3 clinical\ntrials have thus far been limited to gene therapy using the HGF gene. Further studies using well-designed larger placebo-controlled\nand long-term randomized control trials (RCTs) will clarify the effectiveness of gene therapy and cell-based therapy for the\ntreatment of CLI. Furthermore, the development of efficient gene transfer systems and effective methods for keeping transplanted\ncells healthy will make these novel therapies more effective and ease the symptoms of CLI.
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