Abstract

Stem Cells in the Treatment of Peripheral Arterial Diseases. Clinical Results and New Frontiers

Alessandro Schiavetta, Main Investigator, Head, Innovative Therapies Unit, Ospedale Santa Corona

Critical limb ischemia (CLI) is a vascular disease affecti! ng lower limbs, which is going to become a demanding challenge because of the aging of the population. Despite advances in endovascular therapies, CLI is associated with high morbidity and mortality. Patients without direct revascularization options have the worst outcomes. To date, 25%-40% of CLI patients are not candidates for surgical or endovascular approaches, ultimately facing the possibility of a major amputation. The multicenter, non controlled NAPLES Study conducted in Italy (Naples University and Pietra Ligure Hospital)aimed to assess the safety and efficacy of autologous bone marrow (BM) transplantation performed in "no-option" patients, in terms of restoring blood perfusion by collateral flow and limb salvage. We decided to set a non-randomized phase II trial because the majority of enrolled subjects were "no-option" patients, in whom the progression of the disease is well-defined and amputation is the only treatment option available, as previously reported. Therefore, on the basis of observations done by us and others, we believed that an untreated control group was unnecessary. Written informed consent for participation was obtained from all patients. Patients were subjected to intra-arterial infusion of autologous bone marrow and followed for 12 months after the treatment. A total volume of 105 ml of bone marrow (BM) aspirate was obtained from all patients from posterior iliac crest puncture with a 15-gauge needle, under local anesthesia and smooth conscious sedation. Five milliliters of BM aspirate was kept for research purposes. The remaining BM aspirate (100 ml) was immediately added to sodium heparin (2,000 units) in 20 ml of normal saline and filtered (bone marrow collection kit 4R2104; Fenwal Inc., Lake Zurich, IL, http://www.fenwalinc.com) to remove large particulate matter, such as fat, bone chips, and clots. The BM aspirate was then ready for intra-arterial direct infusion ipsilatera