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Background Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. Methods A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. Discussion Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. Trial registration ClinicalTrials.govNCT04466007. Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.

Background: A multidisciplinary approach and Doppler ultrasound (DU) assessment for the creation and maintenance of arteriovenous fistulas (AVF) for haemodialysis can improve prevalence and patency. The aim of this study was to analyze the impact of a new multidisciplinary vascular access (VA) clinic with routine DU. Material and methods: We analyzed the VA clinic results from 2014 and 2015, before and after the implementation of a multidisciplinary team protocol (vascular surgeon/nephrologist) with routine DU in preoperative mapping and prevalent AVF. Results: We analyzed 345 and 364 patients from 2014 and 2015 respectively. The number of surgical interventions was similar in both periods (p = .289), with a trend toward an increase in preventive surgical repair of AVF in 2015 (17 vs. 29, p = .098). 155 vs. 169 new AVF were performed in 2014 and 2015, with a significantly lower primary failure rate in 2015 (26.4 vs. 15.3%, p = .015), and a non-significant increase in radiocephalic AVF, 25.8 vs. 33.2% (n = 40 vs. 56), p = .159. The concordance between the indication at the clinic and the surgery performed also increased (81.3 vs. 93.5%, p = .001). Throughout 2015 fewer complementary imaging test were requested from the clinic (78 vs. 35, p

Resumen Fundamento y objetivo REACH es el mayor registro mundial disenado para obtener informacion sobre el control de factores de riesgo vascular y tratamiento preventivo en una poblacion con aterotrombosis sintomatica o de riesgo alto para desarrollarla. El objetivo del presente estudio es conocer la tasa de episodios cardiovasculares en la muestra de la poblacion espanola incluida en el registro, tras un ano de seguimiento e intervencion. Material y metodo El registro REACH Espana es un estudio de cohorte prospectivo de sujetos con solo factores de riesgo vascular (SFR) para aterotrombosis o con enfermedad vascular (EV) sintomatica: enfermedad coronaria (EC) y/o cerebrovascular (ECV) y/o arterial periferica (EAP). Las variables principales del estudio fueron la tasa de mortalidad global, cardiovascular y la del conjunto de mortalidad cardiovascular mas infarto de miocardio (IM), mas accidente cerebrovascular, mas hospitalizacion cardiovascular al ano de seguimiento. Resultados Espana incluyo a 2.516 sujetos, de los cuales 2.252 completaron el ano de seguimiento, con una edad media de 68,1 anos (73,8% de varones). El 11,6% presentaban SFR y el 88,5% EV establecida, el 55% EC, el 33% ECV y el 17% EAP. La tasa anual en los grupos EV y SFR fue, respectivamente, para la mortalidad global del 3,57 y el 1,98% (p=NS), para la mortalidad cardiovascular del 2,69% y el 0,62% (p Conclusiones Los datos del registro REACH espanol al ano de seguimiento en sujetos con aterotrombosis establecida o con factores de riesgo para desarrollarla muestran una alta tasa de mortalidad total y de la combinacion de episodios cardiovasculares mayores, que se acentua cuando mayor es el numero de territorios vasculares afectados.

Purpose: A new technique for stem cells intrapancreatic autotransplantation in rats. Basic Procedures: Section of a femoral diaphysis and aspirations of the bone marrow in both femoral segments were performed. A Kirschner needle was placed into the femur. Cells were isolated in Ficoll gradients and preserved at 4–68C. The second day, cells were injected, via aortic celiac trunk, into the pancreas of the same rat. Results: Femoral surgery were well tolerated. Intrapancreatic homing of the injected cells was suggested with methylene blue injection that stained the pancreas, and proved by labeled cells in pancreas sections. Cell counts after Ficoll isolation were 1 10 6 6 2 10 5 ES. Conclusions: A technique is described for stem cell autotransplantation in rats. First we obtain autologous bone marrow-derived stem cells. Second, we inject the cells in the pancreas of the donor rat. This approach can be applied to experimental diabetes and other pancreatic processes. V V C 2006 Wiley-Liss, Inc. Microsurgery 26:539–542, 2006.