Ruiz-Salmeron, Rafaelde la Cuesta-Diaz, AntonioConstantino-Bermejo, ManuelPérez-Camacho, ImmaculadaMarcos-Sánchez, FranciscoHmadcha, AbdelkrimSoria, Bernat2015-12-022015-12-022011-10-01Ruiz-Salmeron R, de la Cuesta-Diaz A, Constantino-Bermejo M, Pérez-Camacho I, Marcos-Sánchez F, Hmadcha A, et al. Angiographic demonstration of neoangiogenesis after intra-arterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia. Cell Transplant. 2011; 20(10):1629-390963-6897http://hdl.handle.net/10668/2096Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't;Critical limb ischemia in diabetic patients is associated with high rates of morbidity and mortality. Suboptimal responses to the available medical and surgical treatments are common in these patients, who also demonstrate limited vascular homeostasis. Neovasculogenesis induced by stem cell therapy could be a useful approach for these patients. Neovasculogenesis and clinical improvement were compared at baseline and at 3 and 12 months after autologous bone marrow-derived mononuclear cell (BMMNC) transplantation in diabetic patients with peripheral artery disease. We conducted a prospective study to evaluate the safety and efficacy of intra-arterial administration of autologous BMMNCs (100-400 × 10(6) cells) in 20 diabetic patients with severe below-the-knee arterial ischemia. Although the time course of clinical effects differed among patients, after 12 months of follow-up all patients presented a notable improvement in the Rutherford-Becker classification, the University of Texas diabetic wound scales, and the Ankle-Brachial Index in the target limb. The clinical outcome was consistent with neovasculogenesis, which was assessed at 3 months by digital subtraction angiography and quantified by MetaMorph software. Unfortunately, local cell therapy in the target limb had no beneficial effect on the high mortality rate in these patients. In diabetic patients with critical limb ischemia, intra-arterial perfusion of BMMNCs is a safe procedure that generates a significant increase in the vascular network in ischemic areas and promotes remarkable clinical improvement.enAnkle-brachial index (ABI)Below the kneeBone marrow-derived mononuclear cells (BMMNCs)Critical limb ischemia (CLI)Digital subtraction angiography (DSA)Peripheral artery disease (PAD)Angiografía de substracción DigitalÍndice tobillo braquialTrasplante de médula óseaAngiopatías diabéticasInfusiones intraarterialesNeovascularización fisiológicaMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Photography::Image Enhancement::Radiographic Image Enhancement::Angiography, Digital SubtractionMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Blood Pressure Determination::Ankle Brachial IndexMedical Subject Headings::Anatomy::Cells::Bone Marrow CellsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Tissue Transplantation::Bone Marrow TransplantationMedical Subject Headings::Diseases::Cardiovascular Diseases::Vascular Diseases::Diabetic AngiopathiesMedical Subject Headings::Check Tags::FemaleMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Routes::Infusions, Parenteral::Infusions, Intra-ArterialMedical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::IschemiaMedical Subject Headings::Anatomy::Body Regions::Extremities::Lower Extremity::LegMedical Subject Headings::Anatomy::Cells::Blood Cells::Leukocytes::Leukocytes, MononuclearMedical Subject Headings::Check Tags::MaleMedical Subject Headings::Named Groups::Persons::Age Groups::Adult::Middle AgedMedical Subject Headings::Phenomena and Processes::Circulatory and Respiratory Physiological Phenomena::Cardiovascular Physiological Phenomena::Cardiovascular Physiological Processes::Neovascularization, PhysiologicMedical Subject Headings::Diseases::Cardiovascular Diseases::Vascular Diseases::Arterial Occlusive Diseases::Arteriosclerosis::Atherosclerosis::Peripheral Arterial DiseaseMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Prospective StudiesMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment OutcomeMedical Subject Headings::Named Groups::Persons::Age Groups::Adult::Agedresearch article22289660open access10.3727/096368910X01771555-3892