Abstract 13953: Therapeutic Angiogenesis for Patients with Ischemic Vasculitis by Autologous Mononuclear Cell Implantation
We have reported that implantation of bone marrow-derived or peripheral blood mononuclear cells (BMMNCs or PBMNCs) induces effective angiogenesis for critical limb ischemia, especially in patients with thromboangitis obliterans (TAO) (Lancet, 2002). The purpose of this study was to evaluate the efficacy of this cell therapy for ischemic vasculitis associated with connective tissue diseases (CTD). A total of 72 patients with CTD (24 systemic sclerosis, 13 systemic lupus erythematosus, 6 mixed connective tissue disease, 5 rheumatoid arthritis, and 24 others) and 75 patients with TAO were enrolled in this prospective, non-randomised multicenter study. Clinical outcomes were graded into three groups: significant (response), improved, and no change. Implantation of BMMNCs (1 to 10x109 cells) was markedly effective in patients with both CTD (n=52; 73% significant, 10% improved, and 17% no change) and TAO (n=65; 76% significant, 15% improved, and 9% no change). Implantation of PBMNCs (1 to 18x109 cells) was also effective for CTD (n=20; 65% significant, 25% improved, and 10% no change) and TAO (n=10; 80% significant, and 20% no change). No serious adverse events were observed up to 36 months. Patients with significant response showed ulcer healing and were free from pain and amputation. These results demonstrated clinical efficacy and safety of the implantation of autologous BMMNCs and PBMNCs into ischemic limbs of patients with CTD, which were comparable to those observed in patients with TAO.
- © 2010 by American Heart Association, Inc.