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Italian Journal of Vascular and Endovascular Surgery 2016 December;23(4):185-90


language: English

Critical limb ischemia: the SMOL Registry

Eugenio CARADONNA 1, Flavio PEINETTI 2, Roberto CHIESA 3, Nicola MANGIALARDI 4, Andrea STELLA 5, Pietro MODUGNO 1, Carlo M. DE FILIPPO 1

1 Giovanni Paolo II Foundation and Institute for Research and Care, Sacro Cuore Catholic University, Campobasso, Italy; 2 Department of General and Cardiovascular Surgery, U. Parini Regional Hospital, Aosta, Italy; 3 Department of Vascular Surgery, San Raffaele Hospital, Vita-Salute University School of Medicine, Milan, Italy; 4 Department of Vascular Surgery, San Filippo Neri Hospital, Rome, Italy; 5 Department of Vascular Surgery, Alma Mater Studiorum University, S. Orsola-Malpighi Polyclinic, Bologna, Italy


Peripheral artery disease can be defined a global pandemic disease and an emergent health care issue. In Italy, the cost of amputation is around € 22,096 per patient only for the National Health System. Social costs are not available but are enormous. Novel therapeutic options are necessary to reduce the incidence of amputation in diabetic and atherosclerotic patients. Since 2002, several other studies have proven that the use of bone marrow stem cell in CLI is safe and improves patient outcome. Several cell populations, cytokines and platelets are necessary to repair the ischemic damage and promote angiogenesis. The mechanism of mobilization of stem cells from the bone marrow in response to ischemic damage is impaired in diabetes and arteriosclerosis. In those systems which harvest stem cells from peripheral blood, the number of cells is reduced and there is a very small amount of cytokines. The Ficoll method impairs cellular yield. The bone marrow concentrate (BMAC) obtained with Harvest SmartPReP 2 has all of the components which are essential for angiogenesis. Harvest SmartPrep2 has the CE marking for use in the peripheral arteries. The published results of no-option CLI treated with BMAC demonstrated that amputation was avoided in 60% in patients who had already been scheduled for amputation. The SMOL Registry has adopted the Harvest SmartPReP 2 system. Diabetic patients with amputation have the same dismal survival of malignant disease and patients with CLI have a 5-year survival of less 50%. According to the current Italian Law, as established by the Supreme Court, physicians must inform a patient with an expectancy of life less than 50% at five years regarding the possibility of a safe therapy, when it is supported by substantial amount of scientific published report. If this is not the case, there might be serious legal consequences.

KEY WORDS: Critical limb ischemia - Amputation - Angiogenesis inducing agents - Diabetes mellitus - Peripheral arterial disease

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