Safety evaluation of clinical gene therapy using hepatocyte growth factor to treat peripheral arterial disease.

摘要: Therapeutic angiogenesis using angiogenic growth factors is expected to be a new treatment for patients with critical limb ischemia (CLI). Because hepatocyte factor (HGF) has potent activity, we investigated the safety and efficiency of HGF plasmid DNA in CLI as prospective open-labeled clinical trial. Intramuscular injection naked was performed ischemic limbs 6 arteriosclerosis obliterans (n=3) or Buerger disease graded Fontaine III IV. The primary end points were improvement symptoms at 12 weeks after transfection. Severe complications adverse effects caused by gene transfer not detected any patients. Of particular importance, no apparent edema observed patient throughout In addition, serum concentration changed therapy period all contrast, reduction pain scale more than 1 cm visual analog 5 Increase ankle pressure index 0.1 long diameter 8 11 ulcers 4 reduced >25%. safe, feasible, can achieve successful limbs. Although present data are conducted demonstrate phase I/early IIa, initial outcome seems indicate usefulness sole CLI.