Mesenchymal stromal cells in human immunodeficiency virus-infected patients with discordant immune response: Early results of a phase I/II clinical trial.

Between 15% and 30% of HIV-infected subjects fail to increase their CD4+ T-cell counts despite continuous viral suppression (immunological nonresponders [INRs]). These subjects have a higher morbidity and mortality rate, but there are no effective treatments to reverse this situation so far. This study used data from an interrupted phase I/II clinical trial to evaluate safety and immune recovery after INRs were given four infusions, at baseline and at weeks 4, 8, and 20, with human allogeneic mesenchymal stromal cells from adipose tissue (Ad-MSCs). Based on the study design, the first 5 out of 15 INRs recruited received unblinded Ad-MSC infusions. They had a median CD4+ nadir count of 16/µL (range, 2-180) and CD4+ count of 253 cells per microliter (171-412) at baseline after 109 (54-237) months on antiretroviral treatment and 69 (52-91) months of continuous undetectable plasma HIV-RNA. After a year of follow-up, an independent committee recommended the suspension of the study because no increase of CD4+ T-cell counts or CD4+ /CD8+ ratios was observed. There were also no significant changes in the phenotype of different immunological lymphocyte subsets, percentages of natural killer cells, regulatory T cells, and dendritic cells, the inflammatory parameters analyzed, and cellular associated HIV-DNA in peripheral blood mononuclear cells. Furthermore, three subjects suffered venous thrombosis events directly related to the Ad-MSC infusions in the arms where the infusions were performed. Although the current study is based on a small sample of participants, the findings suggest that allogeneic Ad-MSC infusions are not effective to improve immune recovery in INR patients or to reduce immune activation or inflammation. ClinicalTrials.gov identifier: NCT0229004. EudraCT number: 2014-000307-26.

Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol.

BACKGROUND: Cellular therapies have been increasingly applied to diverse human diseases. Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction. However, less information is available about the role of BMMNC therapy for the treatment of dilated myocardiopathies (DCs) of non-ischemic origin. This article presents the methodological description of a study aimed at investigating the efficacy of intracoronary injection of autologous BMMNCs in the improvement of the ventricular function of patients with DC. METHODS: This randomised, placebo-controlled, double-blinded phase IIb clinical trial compares the improvement on ventricular function (measured by the changes on the ejection fraction) of patients receiving the conventional treatment for DC in combination with a single dose of an intracoronary infusion of BMMNCs, with the functional recovery of patients receiving placebo plus conventional treatment. Patients assigned to both treatment groups are monitored for 24 months. This clinical trial is powered enough to detect a change in Left Ventricular Ejection Fraction (LVEF) equal to or greater than 9%, although an interim analysis is planned to re-calculate sample size. DISCUSSION: The study protocol was approved by the Andalusian Coordinating Ethics Committee for Biomedical Research (Comité Coordinador de Ética en Investigación Biomédica de Andalucia), the Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios), and is registered at the EU Clinical Trials Register (EudraCT: 2013-002015-98). The publication of the trial results in scientific journals will be performed in accordance with the applicable regulations and guidelines to clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02033278 (First Posted January 10, 2014): https://clinicaltrials.gov/ct2/show/NCT02033278 ; EudraCT number: 2013-002015-98, EU CT Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002015-98 . Trial results will also be published according to the CONSORT statement at conferences and reported peer-reviewed journals.

Algunas consideraciones sobre las infecciones posoperatorias / Some considerations about postoperative infections

La tasa de complicaciones infecciosas posoperatorias se eleva en el paciente quirúrgico, entre otras razones, debido a que resulta insuficiente el conocimiento sobre la génesis de los factores que las provocan. Esto incrementa significativamente su persistencia y las consecuencias negativas que inciden sobre el enfermo, la institución sanitaria y el sistema de salud. De ahí, la necesidad de profundizar en los diferentes aspectos cognoscitivos sobre el tema. Esta revisión actualizada pretende esclarecer los aspectos fundamentales concernientes a su génesis, diagnóstico y tratamiento preventivo y curativo con vistas a disminuir la morbilidad y mortalidad por esta lamentable complicación posquirúrgica(AU)

The rate of postoperative infective complications increases in the surgical patient due, among other reasons, to poor knowledge on the genesis of causative factors. This significantly raises their level of persistence and the negative consequences for the patient, the health institution and the health system; hence the need of delving into the different cognitive aspects of this topic. This updated review was intended to clarify the fundamental aspects of their genesis, diagnosis and preventive and curative treatment with a view to reducing morbidity and mortality from this terrible post surgical complication(AU)

Algunas consideraciones sobre las infecciones posoperatorias / Some considerations about postoperative infections

La tasa de complicaciones infecciosas posoperatorias se eleva en el paciente quirúrgico, entre otras razones, debido a que resulta insuficiente el conocimiento sobre la génesis de los factores que las provocan. Esto incrementa significativamente su persistencia y las consecuencias negativas que inciden sobre el enfermo, la institución sanitaria y el sistema de salud. De ahí, la necesidad de profundizar en los diferentes aspectos cognoscitivos sobre el tema. Esta revisión actualizada pretende esclarecer los aspectos fundamentales concernientes a su génesis, diagnóstico y tratamiento preventivo y curativo con vistas a disminuir la morbilidad y mortalidad por esta lamentable complicación posquirúrgica(AU)

The rate of postoperative infective complications increases in the surgical patient due, among other reasons, to poor knowledge on the genesis of causative factors. This significantly raises their level of persistence and the negative consequences for the patient, the health institution and the health system; hence the need of delving into the different cognitive aspects of this topic. This updated review was intended to clarify the fundamental aspects of their genesis, diagnosis and preventive and curative treatment with a view to reducing morbidity and mortality from this terrible post surgical complication(AU)

Estancia hospitalaria de pacientes con antibioticoterapia por infecciones posoperatorias / Hospitalization of patients with antibiotic therapy due to postoperative infections

Se realizó un estudio descriptivo, de serie de casos, de 258 pacientes intervenidos de forma urgente o electiva durante el trienio 2012-2014 en el Servicio de Cirugía General del Hospital Provincial Docente Clinicoquirúrgico "Saturnino Lora Torres" de Santiago de Cuba, quienes presentaron infecciones posoperatorias, con el propósito de identificar diferentes factores relacionados con el empleo de antibióticos ante esta complicación. Entre los resultados sobresalientes se obtuvo que la estancia hospitalaria se prolongara por más de 14 días en más de la mitad de los pacientes cuyas operaciones quirúrgicas fueron clasificadas como contaminadas o sucias, y que en el período preoperatorio se aplicaron antibióticos en 77,1 % de la serie, mientras en la fase posoperatoria se administraron en todos los infectados. Asimismo, los estudios microbiológicos mostraron positividad en 86,5 % y los microorganismos más comúnmente aislados fueron gramnegativos: Klebsiella, estafilococo patógeno, Escherichia coli y Acinetobacter. Pudo concluirse que la política del uso racional de antibióticos con fines profilácticos y terapéuticos, debe relacionarse con la circulación intrahospitalaria de gérmenes, de acuerdo con el mapa microbiológico y la resistencia de estos, para así implementar un protocolo estandarizado al respecto.

A descriptive, serial cases study, of 258 patients undergoing surgery in an emergent or elective way who presented postoperative infections was carried out during the triennium 2012-2014 in the General Surgery Service of "Saturnino Lora Torres" Teaching Clinical Surgical Provincial Hospital in Santiago de Cuba, with the purpose of identifying different factors related to the use of antibiotics in these cases. Among the outstanding results it was obtained that the hospitalization lasted more than 14 days in more than half of the patients whose surgical operations were classified as polluted or dirty, and that in the preoperatory period antibiotics were applied in 77.1 % of the series, while in the postoperative phase antibiotics were administered in all those infected. Also, the microbiological studies showed positivity in 86.5 % and the most common isolated microorganisms were gramnegative: Klebsiella, pathogen Staphylococcus, Escherichia coli and Acinetobacter. It was concluded that the politics of the rational use of antibiotics with preservatives and therapeutic ends, should be related to the intrahospital circulation of germs, according to the microbiological map and the resistance of these, so as to implement a standardized protocol in this respect.

Estancia hospitalaria de pacientes con antibioticoterapia por infecciones posoperatorias / Hospitalization of patients with antibiotic therapy due to postoperative infections

Se realizó un estudio descriptivo, de serie de casos, de 258 pacientes intervenidos de forma urgente o electiva durante el trienio 2012-2014 en el Servicio de Cirugía General del Hospital Provincial Docente Clinicoquirúrgico Saturnino Lora Torres de Santiago de Cuba, quienes presentaron infecciones posoperatorias, con el propósito de identificar diferentes factores relacionados con el empleo de antibióticos ante esta complicación. Entre los resultados sobresalientes se obtuvo que la estancia hospitalaria se prolongara por más de 14 días en más de la mitad de los pacientes cuyas operaciones quirúrgicas fueron clasificadas como contaminadas o sucias, y que en el período preoperatorio se aplicaron antibióticos en 77,1 por ciento de la serie, mientras en la fase posoperatoria se administraron en todos los infectados. Asimismo, los estudios microbiológicos mostraron positividad en 86,5 por ciento y los microorganismos más comúnmente aislados fueron gramnegativos: Klebsiella, estafilococo patógeno, Escherichia coli y Acinetobacter. Pudo concluirse que la política del uso racional de antibióticos con fines profilácticos y terapéuticos, debe relacionarse con la circulación intrahospitalaria de gérmenes, de acuerdo con el mapa microbiológico y la resistencia de estos, para así implementar un protocolo estandarizado al respecto(AU)

A descriptive, serial cases study, of 258 patients undergoing surgery in an emergent or elective way who presented postoperative infections was carried out during the triennium 2012-2014 in the General Surgery Service of Saturnino Lora Torres Teaching Clinical Surgical Provincial Hospital in Santiago de Cuba, with the purpose of identifying different factors related to the use of antibiotics in these cases. Among the outstanding results it was obtained that the hospitalization lasted more than 14 days in more than half of the patients whose surgical operations were classified as polluted or dirty, and that in the preoperatory period antibiotics were applied in 77.1 percent of the series, while in the postoperative phase antibiotics were administered in all those infected. Also, the microbiological studies showed positivity in 86.5 percent and the most common isolated microorganisms were gramnegative: Klebsiella, pathogen Staphylococcus, Escherichia coli and Acinetobacter. It was concluded that the politics of the rational use of antibiotics with preservatives and therapeutic ends, should be related to the intrahospital circulation of germs, according to the microbiological map and the resistance of these, so as to implement a standardized protocol in this respect(AU)

Factores asociados a la mortalidad por infecciones posoperatorias / Factors associated with mortality from postoperative infections

Introducción: las infecciones posoperatorias favorecen la ocurrencia de otras complicaciones, en ocasiones letales, razón por la que elevan los índices de morbilidad y mortalidad. Objetivo: identificar diferentes factores relacionados con la aparición de las infecciones posoperatorias que están asociados con la mortalidad por sus efectos. Métodos: se realizó un estudio descriptivo, de serie de casos, basado en 258 pacientes operados de forma urgente o electiva durante el trienio 2012-2014 en el Servicio de Cirugía General del Hospital Provincial "Saturnino Lora" de Santiago de Cuba. Estos pacientes presentaron infecciones posquirúrgicas, de los cuales 27 (10,5 por ciento) fallecieron.Resultados: la aparición de la infección posquirúrgica estuvo asociada a las intervenciones contaminadas en la cirugía urgente seguida por las limpias y limpias contaminadas para la electiva, así como la infección del sitio operatorio superficial y en otras localizaciones en ambos grupos. La mortalidad estuvo relacionada con la edad mayor de 60 años, el estado físico preoperatorio ASA ≥ III, la cirugía abdominal urgente, contaminada, el tiempo quirúrgico mayor de una hora y las reintervenciones. Conclusiones: en todos los fallecidos repercutieron los factores de predicción para la ocurrencia de infecciones posoperatorias y como consecuencia de la correlación de cada uno de ellos, se acrecentó el riesgo de morir(AU)

Introduction: postoperative infections cause other complications, sometimes lethal ones, a reason why they raise morbidity and mortality rates. Objective: to identify different factors related to the occurrence of postoperative infection and which, because of their effects, they are associated with mortality. Methods: a descriptive study of case series was carried out, based on 258 patients who had emergency or elective surgery in the Department of Surgery of Saturnino Lora Provincial Hospital of Santiago de Cuba (2012-2014). These patients had postoperative infections, and 27 of them (10.5 percent) died. Results: the occurrence of postoperative infection was associated with contaminated interventions in emergency surgery, followed by clean and clean-contaminated for the elective one, as well as surface surgical site infection and in other locations in both groups. Mortality was associated with age (over 60 years), preoperative fitness ASA≥III, contaminated emergency abdominal surgery, operating time longer than an hour and second interventions.Conclusions: In all the deceased patients there was a repercussion of predicting factors for the occurrence of postoperative infections and, as a result of the correlation of each of them, the risk of dying increased(AU)

Factores asociados a la mortalidad por infecciones posoperatorias / Factors associated with mortality from postoperative infections

Introducción: las infecciones posoperatorias favorecen la ocurrencia de otras complicaciones, en ocasiones letales, razón por la que elevan los índices de morbilidad y mortalidad. Objetivo: identificar diferentes factores relacionados con la aparición de las infecciones posoperatorias que están asociados con la mortalidad por sus efectos. Métodos: se realizó un estudio descriptivo, de serie de casos, basado en 258 pacientes operados de forma urgente o electiva durante el trienio 2012-2014 en el Servicio de Cirugía General del Hospital Provincial Saturnino Lora de Santiago de Cuba. Estos pacientes presentaron infecciones posquirúrgicas, de los cuales 27 (10,5 por ciento) fallecieron. Resultados: la aparición de la infección posquirúrgica estuvo asociada a las intervenciones contaminadas en la cirugía urgente seguida por las limpias y limpias contaminadas para la electiva, así como la infección del sitio operatorio superficial y en otras localizaciones en ambos grupos. La mortalidad estuvo relacionada con la edad mayor de 60 años, el estado físico preoperatorio ASA ≥ III, la cirugía abdominal urgente, contaminada, el tiempo quirúrgico mayor de una hora y las reintervenciones. Conclusiones: en todos los fallecidos repercutieron los factores de predicción para la ocurrencia de infecciones posoperatorias y como consecuencia de la correlación de cada uno de ellos, se acrecentó el riesgo de morir(AU)

Introduction: postoperative infections cause other complications, sometimes lethal ones, a reason why they raise morbidity and mortality rates. Objective: to identify different factors related to the occurrence of postoperative infection and which, because of their effects, they are associated with mortality. Methods: a descriptive study of case series was carried out, based on 258 patients who had emergency or elective surgery in the Department of Surgery of Saturnino Lora Provincial Hospital of Santiago de Cuba (2012-2014). These patients had postoperative infections, and 27 of them (10.5 percent) died. Results: the occurrence of postoperative infection was associated with contaminated interventions in emergency surgery, followed by clean and clean-contaminated for the elective one, as well as surface surgical site infection and in other locations in both groups. Mortality was associated with age (over 60 years), preoperative fitness ASA≥III, contaminated emergency abdominal surgery, operating time longer than an hour and second interventions. Conclusions: In all the deceased patients there was a repercussion of predicting factors for the occurrence of postoperative infections and, as a result of the correlation of each of them, the risk of dying increased(AU)

Repercusión socioeconómica de las infecciones posoperatorias / Socioeconomic repercussion of the postoperative infections

Se exponen aspectos relacionados con las infecciones posquirúrgicas, las cuales no solo revisten interés científico, sino que además constituyen un verdadero problema socioeconómico, puesto que elevan los índices de morbilidad y mortalidad, así como los costos hospitalarios. Desde el punto de vista social, determinan la valoración de los ciudadanos respecto a la incapacidad institucional, el prestigio de los profesionales de la salud y la ruptura de la estabilidad familiar, atribuible a la pérdida de seres queridos o su invalidez total, parcial, temporal o definitiva(AU)

The aspects related to the postsurgical infections are exposed, which not only have scientific interest, but also constitute a true socioeconomic problem, since they elevate the morbidity and mortality indexes, as well as the hospital costs. From the social point of view, they determine the valuation of the citizens regarding the institutional inability, the health professionals prestige and the family stability rupture, attributable to the loss of loved relatives or their total, partial, temporary or definitive disability(AU)

Factores de riesgo relacionados con las infecciones posoperatorias / Risk factors related to the postoperative infections

Se realizó una investigación descriptiva y observacional, de serie de casos, basada en los 258 pacientes que presentaron complicaciones posoperatorias infecciosas, tras habérseles practicado intervenciones quirúrgicas, tanto de forma electiva como urgente, en el período comprendido desde enero de 2012 hasta diciembre de 2014. Entre los principales resultados se obtuvo un predominio de los pacientes mayores de 60 años (38,4 %) y operados con urgencia (82,1 %); razón por la cual se observó que las intervenciones clasificadas como contaminadas (43,4 %) y sucias (23,6 %) ocuparon un lugar importante en la génesis de esta complicación. También fue más frecuente la infección del sitio operatorio superficial (55,5 %) respecto al resto de las localizaciones. Se pudo concluir que factores como el nivel de contaminación de la intervención, el tiempo quirúrgico prolongado, el estado físico preoperatorio en las clases II y III de la American Society of Anesthesiology, el tipo de operación y la edad del paciente, fueron decisivos en la aparición de las infecciones posquirúrgicas.

A descriptive and observational serial cases investigation, based on the 258 patients that presented infectious postoperative complications, after undergoing surgical interventions, either in an elective way or as an emergency, was carried out from January, 2012 to December, 2014. Among the main results there was a prevalence of the patients older than 60 (38.4%) and those undergone surgery as an emergency (82.1%); reason why it was observed that the interventions classified as polluted (43.4%) and dirty (23.6%) occupied an important place in the genesis of this complication. It was also more frequent the infection of the superficial operative place (55.5%) regarding the rest of the localizations. It was concluded that factors as the intervention contamination level, the long-lasting surgical time, preoperative physical state in the classes II and III of the American Society of Anesthesiology, operation type and the patient's age, were decisive in the emergence of postsurgical infections.

Factores de riesgo relacionados con las infecciones posoperatorias / Risk factors related to the postoperative infections

Se realizó una investigación descriptiva y observacional, de serie de casos, basada en los 258 pacientes que presentaron complicaciones posoperatorias infecciosas, tras habérseles practicado intervenciones quirúrgicas, tanto de forma electiva como urgente, en el período comprendido desde enero de 2012 hasta diciembre de 2014. Entre los principales resultados se obtuvo un predominio de los pacientes mayores de 60 años (38,4 por ciento) y operados con urgencia (82,1 por ciento); razón por la cual se observó que las intervenciones clasificadas como contaminadas (43,4 por ciento) y sucias (23,6 por ciento) ocuparon un lugar importante en la génesis de esta complicación. También fue más frecuente la infección del sitio operatorio superficial (55,5 por ciento) respecto al resto de las localizaciones. Se pudo concluir que factores como el nivel de contaminación de la intervención, el tiempo quirúrgico prolongado, el estado físico preoperatorio en las clases II y III de la American Society of Anesthesiology, el tipo de operación y la edad del paciente, fueron decisivos en la aparición de las infecciones posquirúrgicas(AU)

A descriptive and observational serial cases investigation, based on the 258 patients that presented infectious postoperative complications, after undergoing surgical interventions, either in an elective way or as an emergency, was carried out from January, 2012 to December, 2014. Among the main results there was a prevalence of the patients older than 60 (38.4 percent) and those undergone surgery as an emergency (82.1 percent); reason why it was observed that the interventions classified as polluted (43.4 percent) and dirty (23.6 percent) occupied an important place in the genesis of this complication. It was also more frequent the infection of the superficial operative place (55.5 percentsi) regarding the rest of the localizations. It was concluded that factors as the intervention contamination level, the long-lasting surgical time, preoperative physical state in the classes II and III of the American Society of Anesthesiology, operation type and the patient's age, were decisive in the emergence of postsurgical infections(AU)

The spectrum of mutations in Southern Spanish patients with hemophilia A and identification of 28 novel mutations.

The aim of this study was to analyze the mutation pattern causing hemophilia A in a population from Southern Spain. Mutation analysis identified the mutation in 99 of the 109 unrelated patients enrolled in the Hemophilia Registry from Andalusia. About 54% of non-inversion mutations identified were previously unreported.

Mitochondrial DNA A4336G mutation in Alzheimer's and Parkinson's diseases.

OBJECTIVES: To determine whether the mitochondrial DNA (mtDNA) A4336G mutation represents a risk factor for Spanish patients with both Alzheimer's disease (AD) and Parkinson's disease (PD). MATERIAL AND METHODS: One hundred and sixty-one AD and 106 PD unrelated patients were included in the study. Seventy-eight age-matched and 144 randomly chosen healthy subjects served as controls. The frequency of the A4336G mutation in these groups was compared using the chi(2) and Fisher's exact tests. p < 0.05 was established as a statistically significant differential value. RESULTS: The mtDNA A4336G mutation was present in 1/161 of AD patients (0.6%), in 3/106 of PD patients (2.8%), in 1/78 of age-matched controls (1.3%) and in 2/144 of the randomly chosen controls (1.4%). These differences were not statistically significant. CONCLUSION: Our results do not support the hypothesis that this mutation represents a risk factor for either AD or PD patients, at least in the case of this Spanish sample.