Treatment of critical limb ischaemia by pIRES/VEGF165/HGF administration

Abstract PURPOSE Prognosis of peripheral artery disease (PAD), especially critical limb ischaemia (CLI), is very poor despite the development of endovascular therapy and bypass surgery. Many patients result in leg amputation. We decided to investigate the safety and efficacy of pIRES/VEGF165/HGF gene therapy (GT) in patients suffered from CLI. METHODS Administration of pIRES/VEGF165/HGF was performed in 12 limbs of 12 patients with rest pain and ischaemic ulcers due to CLI. Plasmid was injected into the muscles of the ischaemic limbs. The levels of VEGF in serum and the ankle-brachial index (ABI) were measured before and after treatment. RESULTS Mean (±SD) plasma levels of VEGF increased non-significantly from 258 ± 81 pg/L to 489 ± 96 pg/L ( P >0.05) 2 weeks after therapy and the ABI improved significantly from 0.27 ± 0.20 to 0.50 ± 0.22 ( P CONCLUSION Intramuscular administration of pIRES/VEGF165/HGF is safe, feasible and effective for patients with critical leg ischaemia.