Regulatory authorities and orthopaedic clinical trials on expanded mesenchymal stem cells

This article is published with open access at Springerlink.comSkeletal injuries requiring bone augmentation techniques are increasing in the context of avoiding or treating difficult cases with bone defects, bone healing problems, and bone regeneration limitations. Musculoskeletal severe trauma, osteoporosis-related fractures, and conditions where bone defect, bone collapse or insufficient bone regeneration occur are prone to disability and serious complications. Bone cell therapy has emerged as a promising technique to augment and promote bone regeneration. Interest in the orthopaedic community is considerable, although many aspects related to the research of this technique in specific indications may be insufficiently recognised by many orthopaedic surgeons. Clinical trials are the ultimate research in real patients that may confirm or refute the value of this new therapy. However, before launching the required trials in bone cell therapy towards bone regeneration, preclinical data is needed with the cell product to be implanted in patients to ensure safety and efficacy. These preclinical studies support the end-points that need to be evaluated in clinical trials. Orthopaedic surgeons are the ultimate players that, through their research, would confirm in clinical trials the benefit of bone cell therapies. To further foster this research, the pathway to eventually obtain authorisation from the National Competent Authorities and Research Ethics Committees under the European regulation is reviewed, and the experience of the REBORNE European project offers information and important clues about the current Voluntary Harmonization Procedure and other opportunities that need to be considered by surgeons and researchers on the topicThis work was supported in part by the European Commission, Seventh Framework Programme (FP7), through the REBORNE Project, grant agreement no. 24187

diseño de investigación del análisis de alternativas para el aprovechamiento de las aguas de rechazo, del proceso de ósmosis inversa en una planta farmacéutica.

propone hacer una evaluación de la calidad del agua de rechazo y analizar las características fisicoquímicas básicas de interés, para establecer un porcentaje de dilución con agua potable, que permita mejorar las características de las aguas de rechazo y así poder reutilizarlas

Associação entre comportamento suicida e sintomas de Anorexia e Bulimia Nervosa em estudantes escolares de Boyacá, Colômbia

La presente investigación tuvo como objetivo establecer la asociación existente entre síntomas de trastornos alimentarios y la ideación e intento suicida en adolescentes de grado octavo a undécimo de instituciones educativas de tres ciudades del departamento de Boyacá, Colombia. Se realizó una estrategia descriptiva con un diseño selectivo probabilístico transversal. La muestra estuvo conformada por 1292 participantes seleccionados mediante muestreo probabilístico estratificado. Con el fin de indagar los factores protectores y de riesgo para la ideación suicida, la presencia de acto suicida y el tamizaje de trastornos de la conducta alimentaria, se aplicó el cuestionario PANSI (Osman, Gutiérrez, Kopper, Barrios & Chiros, 1998), la encuesta sociodemográfica elaborada por las autoras y el SCOFF (Morgan, Reid & Lacey, 1999), respectivamente. Los resultados muestran que del total de participantes, el 17.8 % (230) piensan en el suicidio como alternativa y que el 42 % de quienes registran sintomatología relacionada con trastornos alimentarios presentan ideación suicida negativa (riesgo). En conclusión, se identificó una correlación baja, pero significativa, entre los trastornos alimentarios y el PANSI negativo (rs = .19 y p = .00), lo que sugiere que a mayor presencia de señales de alarma de trastornos alimentarios, más factores de riesgo de ideación suicida.Esta pesquisa teve como objetivo estabelecer a associação existente entre sintomas de transtornos alimentares e ideação suicida e sua tentativa em adolescentes de instituições educativas de três cidades do estado de Boyacá, Colômbia. Realizou-se uma estratégia descritiva com um desenho seletivo probabilístico de corte transversal. A amostra foi conformada por 1 292 participantes selecionados mediante amostragem probabilística estratificada. A fim de indagar os fatores protetores e de risco para a ideação suicida, a presença de ato suicida e o triagem de transtornos do comportamento alimentar, aplicaram-se o questionário PANSI (Osman, Gutiérrez, Kopper, Barrios & Chiros, 1998), a enquete sociodemográfica elaborada pelas autoras e o SCOFF (Morgan, Reid & Lacey, 1999), respectivamente. Os resultados mostraram que, do total de participantes, 17.8 % (230) pensam no suicídio como alternativa e que 42 % dos que registram sintomatologia relacionada com transtornos alimentares apresentam ideação suicida negativa (risco). Em conclusão, identificou-se uma correlação baixa, mas significativa, entre os transtornos alimentares e o PANSI negativo (rs = .19 e p = .00), o que sugere que, quanto maior presença de sinais de alarme de transtornos alimentares, mais fatores de risco de ideação suicida há.This research aimed to establish the relationship between eating disorders and suicidal ideation and attempt, in adolescents from eighth to eleventh grade of educational institutions in three cities of Boyacá (Colombia). The study conducted was empirical and used quantitative methodology. A descriptive strategy was implemented using a cross-sectional design. The sample consisted of 1292 participants, selected by stratified probability sampling. The instruments applied were firstly, the Positive and Negative Suicidal Ideation PANSI Inventory (Osman, Gutiérrez, Kopper, Barrios and Chiros, 1998) to inquire about the protective and risk factors for suicidal ideation and the presence of suicidal act. Secondly, the Sick Control on Fat Food -SCOFF Questionnaire (Morgan, Reid & Lacey, 1999) to carry out a screening for eating disorders. Thirdly, a sociodemographic survey designed by the authors, to characterize the sample of participants. Results show that out of the total number of young people who participated in the study, 230 (17.8%) consider suicide as an alternative. The research identified low but significant correlation between eating disorders and negative PANSI (rs = .19 and p = 0.00), suggesting that the higher the presence of alarm signals of eating disorders, the higher the risk factors for suicidal ideation

Políticos contra los partidos. Experiencias antipartidos en Chile 1989-2017

This article analyzes anti-party experiences that emerged in Chile between 1989 and 2017. The text proposes a typology to recognize the antiparty forms and manifestations that have arisen within the political system,especially those adopted by traditional parties and by those who have burst onto the political scene for first time. It is noted that the anti-party phenomenon can be adopted by organizations and leaderships situated both on the left and the right of the political spectrum. On the left, the anti-party strategy is used to displace parties that have failed to promote deep political and economic transformations. On the other hand, on the right it has been used as a mechanism for defense of the status quo, acting to prevent changes to existing political institutions.Este artículo analiza experiencias antipartidos que emergieron en Chile entre 1989-2017. Se propone una tipología para reconocer las formas y manifestaciones antipartidos que han surgido al interior del sistema político, en especial las adoptadas por partidos “tradicionales” y por quienes irrumpen por primera vez en la escena política. Se advierte que el fenómeno antipartidos puede ser adoptado tanto en organizaciones y liderazgos de izquierda como de derecha. Desde la izquierda la estrategia antipartido se utiliza para desplazar a los partidos que no han logrado impulsar transformaciones políticas y económicas profundas. En cambio, desde la derecha ha sido empleado como mecanismo de defensa del statu quo y que permite evitar transformaciones a la institucionalidad política vigente

Competitividad en la comercialización de insumos eléctricos de Cubas Eléctrica S.A, con respecto a empresas distribuidoras ubicadas en la ciudad de Estelí, en el año 2016

Esta investigación determina los factores de la Competitividad en la comercialización de insumos eléctricos de Cubas Eléctrica S.A, con respecto a empresa distribuidoras ubicadas en la ciudad de Estelí, Nicaragua, en el año 2016, con el fin de mejorar la capacidad con relación a la competencia, así mismo se propondrá estrategias que potencialicen la competitividad de la misma. El enfoque de la investigación es aplicada y cuantitativa. El universo de estudio son 46 ferreterías, además se han empleando como técnicas de recolección de datos, encuestas a los clientes que compran a las 6 ferreterías más competitivas y entrevistas a los propietarios de las ferreterías, ambas técnicas recopilaron la veracidad de la información brindada en el documento

Aerosols generation using Er,Cr:YSGG laser compared to rotary instruments in conservative dentistry: a preliminary study

Background: In restorative dentistry, the use of high-speed air turbine, which generates aerosols, can be associated with the transmission of airborne diseases. New laser technologies could be useful in reducing the amount of aerosols, but there is a lack of scientific research on this topic. Material and Methods: This is a descriptive study to analyze the amount of aerosols produced after class I cavity preparation using high-speed air turbine (group 1) and Er,Cr:YSGG laser with two different parameters (groups 2 and 3). Fluorescein dye was incorporated into the coolant reservoir in order to visualize the production of aerosols during each procedure. Tooth preparation was performed in a typodont with human lower molar tooth under rubber dam isolation. The procedure was carried out in a transparent plastic box to avoid aerosols dispersion. Sixteen grade I cellulose filter discs were distributed along the surfaces of the box. The area contaminated with aerosols in the filters was measured using ultraviolet illumination. Results: In group 1, the contaminated surface area covered with fluorescein dye reached 77.3% (1349 cm2) of the total; in group 2 (laser with 80% water) we observed 7.3% (128 cm2) and in group 3 (laser with 40% water) it was 3.8% (68 cm2). The reduction in water parameter from 80% to 40% coincided with 48% reduction of the contaminated area on the filter discs. Focusing on the surfaces of the box, we noted that the mean contamination on the left side was more than on the right side in all three experimental groups. In group 1 using air turbine, we measured a mean of 102.6[ 7.5 SD]cm2 on the left side, compared to 70.6[ 32.3 SD]cm2 on the right side. In laser groups 2 and 3, a mean of 12.8[ 14.9 SD]cm2 and 6.8 [ 5.7SD]cm2, respectively, was described on the left surface versus 0 cm2 of surface contamination on the right surface. Conclusions: The contaminated area during the procedure of class I cavity preparation, is reduced by 70% using Er,- Cr:YSGG laser compared to high-speed turbine. A slightly higher contamination was observed between laser groups with 80% versus 40% water. The use of Er,Cr:YSGG laser in restorative dentistry can be a valid treatment alternative to reduce aerosols production compared to conventional high-speed rotary instruments

Determinación de ácido hipúrico en orina como indicador de exposición al tolueno en trabajadores de imprentas en los distritos de la provincia de Lima

En el presente trabajo, realizamos la cuantificación de los niveles de ácido hipúrico en relación a la creatinina urinaria en 50 maquinistas varones, que laboran en imprentas de Lima cercado, en donde hacen uso de tintas que contienen tolueno (técnicas de flexografía y huecograbado). La cuantificación de acido hipúrico en orina fue realizada por el método perteneciente al manual de métodos analíticos de la NIOSH. Los niveles de Ácido Hipúrico en orina fueron menores a 1.6g ácido hipúrico/g creatinina, límite máximo permitido, dado por la AMERICAN CONFERENCE OF GOVERNMENTAL INDUSTRIAL HYGIENSTS. El promedio de la concentración de ácido hipúrico en orina del grupo expuesto es de 0.758 ± 0.275 g ácido hipúrico/g creatinina. sin embargo, estos valores están ligeramente elevados con respecto al grupo control, cuyo promedio es 0.422 ± 0.036 g ácido hipúrico/ g creatinina. El análisis toxicológico se realizó en el Laboratorio de Toxicología y Química Legal de la Facultad de Farmacia y Bioquímica de la Universidad Nacional Mayor de San Marcos.-- In this present research, it was carried out the quantitative determination of hippuric acid levels in relation to urinary creatinine in fifty male workers, who work in prints of center of Lima, where they make use of inks containing toluene (Flexography and Rotogravure techniques), The quantitative determination of hippuric acid was carried out by the method belongs to the Manual of Analytical Methods according to the NIOSH (The National Institute for Occupational Safety and Health). Hippuric acid levels in urine were less than 1.6g hippuric acid/g creatinine, the maximum permissible limit given by the AMERICAN CONFERENCE OF GOVERNMENTAL INDUSTRIAL HYGIENSTS. The average concentration of hippuric acid in urine in the exposed group was 0.758 ± 0.275 g hippuric acid/g creatinine. The toxicological analysis was carried out in the Toxicology and Legal Chemistry Laboratory of the Faculty of Pharmacy and Biochemistry of San Marcos Major National University.Tesi

Early efficacy evaluation of mesenchymal stromal cells (MSC) combined to biomaterials to treat long bone non-unions

Artículo con numerosos autores, sólo se recogen el primero y los pertenecientes a la UAMBackground and study aim: Advanced therapy medicinal products (ATMP) frequently lack of clinical data on efficacy to substantiate a future clinical use. This study aims to evaluate the efficacy to heal long bone delayed unions and non-unions, as secondary objective of the EudraCT 2011-005441-13 clinical trial, through clinical and radiological bone consolidation at 3, 6 and 12 months of follow-up, with subgroup analysis of affected bone, gender, tobacco use, and time since the original fracture. Patients and methods: Twenty-eight patients were recruited and surgically treated with autologous bone marrow derived mesenchymal stromal cells expanded under Good Manufacturing Practices, combined to bioceramics in the surgical room before implantation. Mean age was 39 ±13 years, 57% were males, and mean Body Mass Index 27 ±7. Thirteen (46%) were active smokers. There were 11 femoral, 4 humeral, and 13 tibial non-unions. Initial fracture occurred at a mean ±SD of 27.9 ±31.2 months before recruit- ment. Efficacy results were expressed by clinical consolidation (no or mild pain if values under 30 in VAS scale), and by radiological consolidation with a REBORNE score over 11/16 points (value of or above 0.6875). Means were statistically compared and mixed models for repeated measurements estimated the mean and confidence intervals (95%) of the REBORNE Bone Healing scale. Clinical and radiological con- solidation were analyzed in the subgroups with Spearman correlation tests (adjusted by Bonferroni). Results: Clinical consolidation was earlier confirmed, while radiological consolidation at 3 months was 25.0% (7/28 cases), at 6 months 67.8% (19/28 cases), and at 12 months, 92.8% (26/28 cases including the drop-out extrapolation of two failures). Bone biopsies confirmed bone formation surrounding the bioce- ramic granules. All locations showed similar consolidation, although this was delayed in tibial non-unions. No significant gender difference was found in 12-month consolidation (95% confidence). Higher consoli- dation scale values were seen in non-smoking patients at 6 ( p = 0.012, t -test) and 12 months ( p = 0.011, t -test). Longer time elapsed after the initial fracture did not preclude the occurrence of consolidation. Conclusion: Bone consolidation was efficaciously obtained with the studied expanded hBM-MSCs com- bined to biomaterials, by clinical and radiological evaluation, and confirmed by bone biopsies, with lower consolidation scores in smokersThis research received funding from the European Union’s Sev- enth Framework Programme ( FP7/FP7-HEALTH-2009 ) with the RE- BORNE Project (under G.A. 241876), and the European Union’s Horizon 2020 Programme ( H2020-SC1 2016-2017 ), with the OR- THOUNION Project (under G.A. 7333288

Tamizaje del desarrollo infantil en los niños y niñas de 4 a 60 meses en el Centro de Salud Mariano Estrella, Cuenca,2022

Antecedentes: El desarrollo infantil es un proceso en el cual los niños y niñas adquieren destrezas y habilidades complejas a medida que interactúan con los diferentes estímulos de su entorno. Si un niño desarrolla ciertas habilidades con lentitud o no las desarrolla, se sospecha de un rezago o riesgo de retraso en el desarrollo. La prueba EDI evalúa el desarrollo infantil e identifica factores de riesgo, permitiendo actuar oportunamente ante las amenazas al desarrollo infantil. Objetivo: Determinar el nivel de desarrollo infantil en los niños y niñas de 4 a 60 meses en el Centro de Salud Mariano Estrella mediante la prueba EDI. Cuenca 2022. Metodología: Estudio cuantitativo, descriptivo, transversal en una población de 147 niños y niñas del Centro de Salud Mariano Estrella. Datos recolectados mediante la prueba de Desarrollo Infantil (EDI) y el formulario de recolección de datos. Para el análisis y la tabulación de los resultados se utilizaron IBM SPSS versión 23, Microsoft Excel y Word 2019. Resultados: De la población investigada, el 57,8% corresponde al sexo masculino, el 44,9% pertenece al grupo de edad lactante mayor (12-35 meses); el 61,2% presentó un desarrollo típico, el 13,6% presentaron rezago y el 25,2% presentaron riesgo de retraso del desarrollo en ambos sexos. Conclusión: En la población investigada, la variable nivel socioeconómico mostró una correlación estadísticamente significativa (p = 0,011) en relación a los resultados del desarrollo infantil.Background: Child development is a process in which children acquire complex skills and abilities as they interact with different stimuli in their environment. If a child develops certain skills slowly or not at all, a lag or risk of developmental delay is suspected. The EDI test evaluates child development and identifies risk factors, allowing timely action to be taken in the face of threats to child development. Objective: To determine the level of child development in children aged 4 to 60 months in the Mariano Estrella health center using the EDI test. Cuenca 2022. Methodology: Quantitative, descriptive, cross-sectional study in a population of 147 children of the Mariano Estrella Health Center. Data were collected using the Child Development Test (EDI) and the data collection form. IBM SPSS version 23, Microsoft Excel and Word 2019 were used for the analysis and tabulation of the results. Results: Of the population studied, 57.8% was male, 44.9% belonged to the older infant age group (12-35 months); 61.2% showed typical development, 13.6% were lagging behind and 25.2% were at risk of developmental delay in both sexes. Conclusion: In the research population, the socio-economic status variable showed a statistically significant correlation (p = 0.011) in relation to child development outcomes.Licenciado en Estimulación Temprana en SaludCuenc

Patient involvement in clinical research: Why, when, and how

The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient