Journal
EUROPEAN JOURNAL OF CARDIOVASCULAR PREVENTION & REHABILITATION
Volume 15, Issue 6, Pages 709-718Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1097/HJR.0b013e3283193a0f
Keywords
antioxidants; bone marrow cells; L-arginine; peripheral arterial disease
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Funding
- Italian Ministry of University and Research [0622153_002]
- Fondation Jerome Lejeune
- Fondazione Banco di Napoli
- Regione Campania
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Background Short-term (within 6 weeks follow-up) clinical studies indicate that implantation of bone marrow cells (BMCs) into ischemic limbs may improve peripheral ischemia. Here, the long-term safety and feasibility of intraarterial autologous BMCs with oral treatment with antioxidants and L-arginine were investigated in patients with critical ischemia on account of advanced atherosclerotic peripheral arterial disease (PAD). Methods Eighteen patients with PAD (advanced III/IV Fontaine stages) were enrolled in this study (NCT00306085). An additional group of 18 patients taking maximal drug therapy that refused BMC therapy served as control. The BMC-treated group received two doses of BMCs in the leg arteries (time 0 and 45 days). After 30 days from the first BMC dose, patients received daily antioxidants, and L-arginine. Therapeutic neoangiogenesis was estimated by angiography and laser Doppler\capillaroscopy. Results Ankle brachial index improvement (Delta ABI: > 0.1) was seen in 10 patients at 3 months and in 12 patients at 12-18 months. Ischemic ulcers improved in 13 patients (after 6-12 months). Although two patients underwent amputation, the mean maximum walking distance significantly increased at 3 months and was sustained up to 18 months. Among conservative patients, 10 underwent amputation in comparison with two BMC-treated patients (55.6 vs. 13.3%; P=0.014). Conclusion This small study shows that intraarterial autologous BMC and antioxidants and L-arginine therapy is safe and effective inpatients with advanced atherosclerotic PAD with positive effects until 18 months. Eur J Cardiovasc Prev Rehabil 15:709-718 (C) 2008 The European Society of Cardiology
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