Abstract 13221: Efficacy and Safety of Therapeutic Angiogenesis by Basic Fibroblast Growth Factor With Atelocollagen Solution in Patients With Critical Limb Ischemia

Abstract

Objectives: To evaluate efficacy and safety of a treatment comprising basic fibroblast growth factor (bFGF) with atelocollagen solution in patients with critical limb ischemia (CLI) due to peripheral artery disease (PAD) or Burger’s disease (TAO). Methods: Human recombinant bFGF (200μg) with 4.8 mL of 3% atelocollagen solution was prepared and injected into forty administration sites in the gastrocnemius muscle of the ischemic leg. The primary endpoint was the safety of the treatment, as evaluated by adverse events. The secondary endpoint was the efficacy of the treatment, as defined by improvements in Fontaine stage, the Rutherford category, rest pain, 6-minute walking distance, ankle brachial pressure index (ABPI), ulcerous/necrotic lesions, and cyanosis 2, 4, 8, 12, 24, and 48 weeks after the treatment from baseline values. Results: 10 CLI subjects received the treatment between November 2009 and November 2011. No serious procedure-related adverse events were observed during the follow-up. Within 48 weeks, the Fontaine stage improved in 4 subjects and was stable in 6 other subjects. The rest pain scale improved in 9 subjects while pain disappeared in 7 subjects. The maximum 6-minute walking distance increased in 7 subjects while 2 regained the ability to walk. Conclusions: The results of the present study demonstrated that angiogenic therapy using bFGF with atelocollagen solution was safe and feasible in patients with CLI.