Early and Long-term Effects of the Autologous Peripheral Stem Cell Implantation for Critical Limb Ischemia.

OBJECTIVE Therapeutic angiogenesis by peripheral blood mononuclear cells (PB-MNCs) implantation has been shown to be a safe and effective treating for critical limb ischemia (CLI). We herein report our investigation of the long-term efficacy of implantation of granulocyte-colony stimulating factor (G-CSF)-induced PB-MNCs to treat patients with CLI for which surgical bypass and/or percutaneous transluminal angioplasty are not possible. Methods and Methods : Eleven cases were enrolled in this study. Following an injection of G-CSF (250 ug/day) for 3 days, PB-MNCs (1.1 ± 0.5 × 10(10) including 1.5 ± 0.2 × 10(7) CD34-positive cells) were harvested by apheresis and then injected into 13 ischemic limbs. RESULTS Resting pain either diminished or improved in 10 cases (91%) at 4 weeks, and ulcer formation was cured in 6 out of 10 limbs (60%) after treatment. The time required to enhance the arteries at the level of foot-joint by angiography which was performed in the abdominal aorta was shortened by 1 month (10 ± 4 seconds) and 6 months (12 ± 1) compared with the pretreatment time (15 ± 5). Three patients died after treatment, and the actuarial survival rate at 3 years was 73%. Freedom from major amputation at 3 years was 92%. CONCLUSION The local injection of G-CSF-induced PB-MNCs showed striking early and long-term effects.