PMID- 19050436 OWN - NLM STAT- MEDLINE DCOM- 20090420 LR - 20221207 IS - 1741-8275 (Electronic) IS - 1741-8267 (Linking) VI - 15 IP - 6 DP - 2008 Dec TI - Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. PG - 709-18 LID - 10.1097/HJR.0b013e3283193a0f [doi] AB - 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 (DeltaABI: >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 in patients with advanced atherosclerotic PAD with positive effects until 18 months. FAU - Napoli, Claudio AU - Napoli C AD - Division of Clinical Pathology, Department of General Pathology, 1st School of Medicine, II University of Naples, Naples, Italy. claudio.napoli@unina2.it/claunap@tin.it FAU - Farzati, Bartolomeo AU - Farzati B FAU - Sica, Vincenzo AU - Sica V FAU - Iannuzzi, Emanuele AU - Iannuzzi E FAU - Coppola, Giuseppe AU - Coppola G FAU - Silvestroni, Andrea AU - Silvestroni A FAU - Balestrieri, Maria Luisa AU - Balestrieri ML FAU - Florio, Anna AU - Florio A FAU - Matarazzo, Angelo AU - Matarazzo A LA - eng SI - ClinicalTrials.gov/NCT00306085 PT - Controlled Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - Eur J Cardiovasc Prev Rehabil JT - European journal of cardiovascular prevention and rehabilitation : official journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology JID - 101192000 RN - 0 (Antioxidants) RN - 94ZLA3W45F (Arginine) SB - IM MH - Administration, Oral MH - Adult MH - Aged MH - Aged, 80 and over MH - Amputation, Surgical MH - Ankle/blood supply MH - Antioxidants/administration & dosage/*therapeutic use MH - Arginine/administration & dosage/*therapeutic use MH - Atherosclerosis/*complications/pathology/physiopathology/therapy MH - Blood Pressure/drug effects MH - *Bone Marrow Transplantation MH - Brachial Artery/physiopathology MH - Chronic Disease MH - Combined Modality Therapy MH - Critical Illness MH - Feasibility Studies MH - Female MH - Humans MH - Ischemia/etiology/pathology/physiopathology/*therapy MH - Laser-Doppler Flowmetry MH - Leg Ulcer/drug therapy/etiology/surgery MH - Lower Extremity/*blood supply MH - Male MH - Microcirculation/drug effects MH - Microscopic Angioscopy MH - Middle Aged MH - Neovascularization, Physiologic/drug effects MH - Peripheral Vascular Diseases/*complications/pathology/physiopathology/therapy MH - Recovery of Function MH - Time Factors MH - Transplantation, Autologous MH - Treatment Outcome MH - Walking EDAT- 2008/12/04 09:00 MHDA- 2009/04/21 09:00 CRDT- 2008/12/04 09:00 PHST- 2008/12/04 09:00 [pubmed] PHST- 2009/04/21 09:00 [medline] PHST- 2008/12/04 09:00 [entrez] AID - 10.1097/HJR.0b013e3283193a0f [doi] PST - ppublish SO - Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):709-18. doi: 10.1097/HJR.0b013e3283193a0f.