MonoNuclear Peripheral Cells at high content of stem cells CD34+ after mobilization with G-CSF for the treatment of Critical Limb Ischemia (CLI).

INTRODUCTION: Critical Limb Ischemia (CLI) patients have a poor prognosis despite they are submitted to conventional treatment. Still up to 30% of these patients is not eligible for either surgical nor endovascular procedures. AIM OF THE STUDY: Evaluate feasibility and outcome of inoculation of mononuclear peripheral cells at high content of stem cells CD34+ as treatment of critical limb ischemia in order to reduce the risk of major amputation of the inferior limb. MATHERIALS AND METHODS: CLI patients unresponsive to pharmacological therapy or with clinically unsatisfactory revascularization are submitted to Mobilized Peripheral Blood MonoNuclear Cell Implantation after G-CSF stimulation. RESULTS: Sixty-two patients have been treated. Amputation Free Survival (AFS) was 81% at 6 months and 77% at 1 and 2 years. The transplanted patients showed a reduction of pain and severity of ulcers’ grade after the procedure. DISCUSSION: The obtained 77% of Amputation Free Survival (AFS) permitted to achieve the primary end point of the study and could be considered an encouraging result in limb salvage. The dose of cells administered (about twice the amount reported in other studies) could be a reason of this good result. This procedure seems to be safe even in the elderly patients. CONCLUSIONS: Stem cells transplantation therapy confirms to be promising for the effective treatment of “no-option” CLI patients with a favorable safety profile. CD34+ cells could have a central role in this treatment as injection of higher doses of these cells seem to be associated with good clinical results. On the other hand, the most advanced stages of arterial disease and limb ischemia are associated with worse clinical response