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pUDK-HGF is a gene therapy product consisting of a naked (non-viral) recombinant plasmid DNA encoding the human hepatocyte growth factor (HGF). It is designed for intramuscular injection to promote angiogenesis and tissue repair by increasing local expression of HGF, a potent angiogenic and cytoprotective growth factor. The drug has been primarily developed for the treatment of critical limb ischemia (CLI), particularly in patients with rest pain or leg ulcers due to peripheral arterial disease. Clinical trials have demonstrated that pUDK-HGF can significantly relieve rest pain, promote ulcer healing, and improve hemodynamic parameters in CLI patients without significant safety concerns. The most efficacious dose identified was 6 mg administered intramuscularly on days 0, 14, and 28[2][3][4][5][8]. Development has been led by Humanwell Healthcare Group and Beijing Institute of Radiation Medicine[1][6].
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