101-P: BENEFICIAL EFFECTS OF AUTOLOGOUS BONE MARROW CELL INFUSION IN PATIENTS WITH CHRONIC CRITICAL LIMB ISCHEMIA: LONG TERM FOLLOW-UP

Abstract

Aim Previous clinical studies indicate that implantation of Bone Marrow Cells (BMCs) into ischemic limbs may improve peripheral ischemia. We previously demonstrated that intraarterial administration of autologous BMC and antioxidants and L-arginine therapy is safe and effective in patients with advanced atherosclerotic peripheral artery disease (PAD) with positive effects until 18 months. Here, we assessed the long-term follow-up of patients until 36 months. Methods In the original study protocol (NCT00306085), we studies 18 patients with PAD (advanced III/IV Fontaine stage) and an additional group of 18 patients taking maximal drug therapy that refused BMC therapy as control. Therapeutic neo-angiogenesis was estimate by clinical assessment, angiography and laser Doppler/capillaroscopy. Results At 18 months of follow-up, among conservative control patients, 10 underwent amputation in comparison with two BMC-treated patients (55.6 vs. 13.3%; p=0.014). Ischemic ulcers improved in 13 patients (after 6-12 months). The follow-up at 36 months of remaining patients confirmed a favorable trends in patients treated with BMCs in comparison to controls (p Conclusions This follow-up study confirmed safety and feasibility of intraarterial autologous BMCs in patients with critical ischemia and advanced atherosclerotic PAD.