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 LB7. Stem Cell Mobilization to Treat Severe Peripheral Artery Disease (STEMPAD)

Eric T. Choi MD1, Patrick Geraghty MD2, Christine Cooke MD2, Kenneth Schechtman MD2, Daniel Link MD2, Christopher M. Chambers MD3, Ravi K. Veeraswamy MD4
1Surgery, Temple University, Philadelphia, PA; 2Washington University, St. Louis, MO; 3Spectrum Health , Grand Rapids, MI;  4Emory University, Atlanta, GA

OBJECTIVES: Currently, there is no proven effective non-invasive treatment for critical limb ischemia (CLI). We hypothesized that mobilization of circulating angiogenic cells into the blood by SQ injections of G-CSF may stimulate angiogenesis and result in a sustained improvement in blood flow in the lower extremities of patients with CLI.

METHODS: Highest at risk population for impending leg amputation was identified as CLI patients (Rutherford category 5 or 6) with no surgical or endovascular revascularization options. After informed consent, all subjects were randomized (1:1) in a double-blinded fashion to treatment with daily SQ injection of G-CSF (5 μg/kg/day) or placebo (saline) for 10 days. The treatment failure was defined as a end point of major leg amputation at 12 months.

RESULTS: We enrolled 28 subjects with 24 completing the 12-month follow-up. Four subjects were disqualified due inability to complete the 10-day treatment. There were no significant differences between treatment and control groups in any of the demographic parameters. At 12 months, the major amputation rates were 50% (6 out of 12) for G-CSF group and 83.3% (10 out of 12) for control group (log-rank test, P=0.188). However, after 4 months, none of 6 remaining G-CSF treated subjects required a major amputation while 3 out of 5 remaining controlled subjects went on to have a major amputation suggesting that minimal effective duration of therapeutic angiogenesis from G-CSF treatment is 4 months. No adverse effects attributable to SQ injection of G-CSF were reported.

CONCLUSIONS: We performed the first randomized, placebo-controlled, double-blinded study of C-GSF–induced angiogenic cell mobilization to treat no-option CLI patients in the US. This analysis was designed to demonstrate feasibility and safety of G-CSF treatment, and the preliminary data support a larger clinical trial to determine the effectiveness of G-CSF in CLI patients.

AUTHOR DISCLOSURES: E. Choi, Financial disclosures; Research Grants: Novartis; Honorarium: Cook Medical; P. Geraghty, Nothing to disclose; C. Chambers, Nothing to disclose; R. Veeraswamy, Nothing to disclose; C. Cooke, Nothing to disclose; K. Schechtman, Nothing to disclose; D. Link, Nothing to disclose.

Posted April 2012

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