P5194Long-term clinical outcome of therapeutic angiogenesis by cell transplantation in patients with critical limb ischemia

Abstract

Background: It reported that critical limb ischemia (CLI) due to peripheral artery disease (PAD), Buerger's disease (TAO) and collagen disease-associated vasculitis (CDV) had a very poor prognosis in the conventional clinical treatment including medical therapy, exercise therapy and revascularization. We assessed the long-term clinical outcomes and safety of the therapeutic angiogenesis by autologous bone marrow mononuclear cells (BM-MNCs) which was a new treatment option of CLI in Japan. Purpose: We designed follow-up field survey study for almost a decade in patients who were performed this therapeutic angiogenesis. Methods: We retrospectively analyzed 346 CLI patients (PAD: n=168, TAO: n=109 and CDV: n=69) with no option for bypass surgery or endovascular treatment who were qualified for BM-MNCs implantation. The overall survival and major amputation-free rate were defined as the primary endpoints of this study. Results: The median follow-up time for surviving patients was 34.6 month (range, 0-164.8 months). The average of age, risk factors, complications of ischemic heart disease, chronic renal disease including dialysis, and cerebrovascular disease were significantly greater in PAD patients than in TAO and CDV patients. Figure A shows the major amputation-free rates of the patients with PAD, TAO and CDV (1-year: 91%, 98% and 97%; 10-year: 47%, 85% and 87%, respectively). Figure B shows the overall survival rates of the patients with PAD, TAO and CDV (1-year: 92%, 99% and 98%; 10-year: 47%, 91% and 68%, respectively). Major amputation and death were seen in patients with PAD within 6 month following autologous BM-MNCs implantation. The major adverse cardiovascular events occurred to 6.0% in patients with PAD, and 1.8% in patients with TAO, and 0% in patients with CDV. Conclusions: The BM-MNCs intramuscular implantation could be alternative treatment strategy for patients with CLI due to PAD, TAO and CDV compared to the conventional clinical strategy. (Figure Presented).