6 research outputs found

    Successful development and clinical translation of a novel anterior lamellar artificial cornea

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    We thank the Andalusian Public Foundation Progress and Health, through the Andalusian Initiative for Advanced Therapies, for assuming the roles and responsibilities of sponsoring this clinical trial. We thank Dr. Manuel de la Rosa and Dr. Salvador Arias Santiago for providing insight and expertise that assisted the research.The datasets generated and/or analyzed during the current study are available in the Gene Expression Omnibus (GEO) public repository, ref. GSE86584 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE86584Blindness due to corneal diseases is a common pathology affecting up to 23 million individuals worldwide. The tissue‐engineered anterior human cornea, which is currently being tested in a Phase I/II clinical trial to treat severe corneal trophic ulcers with preliminary good feasibility and safety results. This bioartificial cornea is based on a nanostructured fibrin–agarose biomaterial containing human allogeneic stromal keratocytes and cornea epithelial cells, mimicking the human native anterior cornea in terms of optical, mechanical, and biological behavior. This product is manufactured as a clinical‐grade tissue engineering product, fulfilling European requirements and regulations. The clinical translation process included several phases: an initial in vitro and in vivo preclinical research plan, including preclinical advice from the Spanish Medicines Agency followed by additional preclinical development, the adaptation of the biofabrication protocols to a good manufacturing practice manufacturing process, including all quality controls required, and the design of an advanced therapy clinical trial. The experimental development and successful translation of advanced therapy medicinal products for clinical application has to overcome many obstacles, especially when undertaken by academia or SMEs. We expect that our experience and research strategy may help future researchers to efficiently transfer their preclinical results into the clinical settings.This study was supported by the Spanish National Plan for Scientific and Technical Research and Innovation (I + D + I) from the Spanish Ministry of Economy and Competitiveness (Carlos III Institute of Health), grants FIS PI14/0955 and FIS PI17/0391 (both cofinanced by ERDF‐FEDER, European Union); by the Spanish Ministry of Health, Social Policy and Equity, grant EC10‐285; and by preclinical research funds from the Regional Ministry of Health through the Andalusian Initiative for Advanced Therapies

    Plan Departamental de Ciencia, Tecnología e Innovación de Antioquia

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    El Plan define las áreas estratégicas de conocimiento, las líneas de acción y de trabajo en las cuales priorizar programas y proyectos, así como los mecanismos de seguimiento y asignación de recursos para generar capacidades territoriales competitivas basadas en CTeI. Para ello se tuvieron en cuenta las capacidades actuales de la región, las potencialidades de expansión, el acceso a los mercados internos y externos, las posibilidades de diferenciación competitiva de nuestro territorio, al igual que la coordinación con otras iniciativas de planificación de la CTeI como la realizada por el Municipio de Medellín desde la Corporación Ruta N. Con la elaboración del Plan, se cumple con lo ordenado en la Política Pública de CTeI de Antioquia, y mediante su ejecución se pretenden generar capacidades basadas en conocimiento para enfrentar los retos que tiene una economía como la antioqueña, la cual tiene carencias básicas en todos los niveles y que apenas empieza a usar el conocimiento con fines económicos

    Pezuela de las Torres. Propuestas bioclimáticas en el espacio público

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    Publicación de los trabajos elaborados por los estudiantes del curso 2019/20 de la asignatura 1602 - La Ciudad y el Medio de la Escuela Técnica Superior de Arquitectura de Madrid de la Universidad Politécnica de Madrid. Muestra una serie de propuestas elaboradas en la asignatura para mejorar bioclimáticamente diferentes espacios públicos municipales en el marco del acuerdo de colaboración académica realizado entre el Departamento de Urbanística y Ordenación del Territorio y el Excmo. Ayuntamiento de Pezuela de Las Torres (Madrid)

    Optimization of adsorptive removal of α-toluic acid by CaO2 nanoparticles using response surface methodology

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    The present work addresses the optimization of process parameters for adsorptive removal of α-toluic acid by calcium peroxide (CaO2) nanoparticles using response surface methodology (RSM). CaO2 nanoparticles were synthesized by chemical precipitation method and confirmed by Transmission electron microscopy (TEM) and high-resolution TEM (HRTEM) analysis which shows the CaO2 nanoparticles size range of 5–15 nm. A series of batch adsorption experiments were performed using CaO2 nanoparticles to remove α-toluic acid from the aqueous solution. Further, an experimental based central composite design (CCD) was developed to study the interactive effect of CaO2 adsorbent dosage, initial concentration of α-toluic acid, and contact time on α-toluic acid removal efficiency (response) and optimization of the process. Analysis of variance (ANOVA) was performed to determine the significance of the individual and the interactive effects of variables on the response. The model predicted response showed a good agreement with the experimental response, and the coefficient of determination, (R2) was 0.92. Among the variables, the interactive effect of adsorbent dosage and the initial α-toluic acid concentration was found to have more influence on the response than the contact time. Numerical optimization of process by RSM showed the optimal adsorbent dosage, initial concentration of α-toluic acid, and contact time as 0.03 g, 7.06 g/L, and 34 min respectively. The predicted removal efficiency was 99.50%. The experiments performed under these conditions showed α-toluic acid removal efficiency up to 98.05%, which confirmed the adequacy of the model prediction

    Suicidal ideation in a European Huntington's disease population.

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    esults from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: the PAUSE study.

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