Abstract 5091: Long-Term Clinical Outcome of Therapeutic Angiogenesis by Autologous Transplantation of Bone Marrow Mononuclear Cells for Patients With Chronic Limb Ischemia - Results of the TACT Trial, Prognosis, Efficacy and Safety

Abstract

Therapeutic Angiogenesis by Cell Transplantation (TACT) study is the first randomized controlled angiogenic cell therapy by intramuscular injection of autologous bone marrow mononuclear cells (BM-MNCs) in the patients with critical limb ischemia. The feasibility of TACT was reported in the Lancet (2002). Objective and Results The present study was designed to assess the 3-year safety and clinical outcomes of this angiogenic cell therapy by investigating the mortality and leg amputation-free interval as primary endpoints. Three year overall survival rates were 80% in patients with peripheral artery disease (PAD) (11 died in 74 patients) and 100% (no death) in 41 patients with thromboangiitis obliterans (TAO, Buerger’s disease). Three-year amputation-free rate was 60% in PAD and 91% in TAO patients (Fig ). These mortality and amputation-free rate were lower than the historical data from the conventional therapies. The multi-variate analysis revealed that the severity of rest pain and repeated experience of bypass surgery are the prognostic factors negatively affecting amputation-free interval. The significant improvement in the rest pain, ulcer size and walking distance was maintained during at least 2 year after the therapy. Conclusions The present study demonstrates that the angiogenic cell therapy using BM-MNCs has an ability to induce a long-term efficient increase in the regional perfusion in ischemic limbs, leading to extension of amputation-free interval. The safety and efficacy are superior to the conventional revascularization therapies. The severity of rest pain and the history of bypass surgery negatively influence the responsiveness to this cell therapy.