A Biobank of Stem Cells of Human Exfoliated Deciduous Teeth: Overview of Applications and Developments in Brazil.

A biobank is an organized collection of biological human material and its associated information stored for research according to regulations under institutional responsibility, without commercial purposes, being a mandatory and strategical activity for research, regenerative medicine, and innovation. Stem cells have largely been employed in research and frequently stored in biobanks, which have been used as an essential source of biological materials. Stem cells of human exfoliated deciduous teeth (SHED) are stem cells which have a high multipotency and can be easily obtained. Besides, this extremely accessible tissue has advantages with respect to storage, as the SHED obtained in childhood can be used in later life, which implies the necessity for the creation and regulation of biobanks. The proper planning for the creation of a biobank includes knowledge of the material types to be stored, requirements regarding handling and storage conditions, storage time, and room for the number of samples. Thus, this study aimed to establish an overview of the development of a SHED biobank. Ethical and legal standardization, current applications, specific orientations, and challenges for the implementation of a SHED biobank were discussed. Through this overview, we hope to encourage further studies to use SHED biobanks.

Una red de biobancos para Chile: investigar hoy, para curar mañana / The implementation of a Biobank network for Chile

The concept "Biobank" is relatively new in the scientific literature, and is not yet consensually defined, even for the World Health Organization (WHO). However, the use of human samples in biomedical research is a very old activity. The organized development of Biobanks in different places has grown in the last decade. The experience in different countries and continents has been diverse. In this special article we intend to summarize, organize and communicate to the national medical and scientific community, (i) the concept of Biobank, (ii) the international experience and a map of the Research Biobanks working in Chile, (iii) the basic biomedical and essential operational aspects to manage a Biobank for Research and (iv) the impact of a National Network of Biobanks implementation in the Chilean Health System. Ethical and regulatory aspects will not be included, given their intrinsic complexity, which should be discussed elsewhere.

Percepción de diversos sectores sociales de Colombia sobre los biobancos con fines de investigación / The perception of different social agents in Colombia regarding biobanks for research purposes

Introducción. Los biobancos con fines de investigación son un bien público que necesita de la participación activa de todas las partes interesadas, por lo cual es importante conocer la percepción que tiene el público general en Colombia sobre su intervención en un biobanco. Objetivo. Indagar en diferentes sectores sociales colombianos sobre su percepción en torno a la donación de material biológico humano para ser almacenado en biobancos con fines de investigación. Materiales y métodos. Se hizo un estudio exploratorio tanto cuantitativo como cualitativo, entre personas sanas de diferentes sectores del país mediante una encuesta anónima sobre su conocimiento y actitudes con respecto a los biobancos. Resultado. La encuesta fue respondida por 368 personas, que incluían investigadores en salud, abogados y miembros de comités de ética de la investigación. El 96 % de los sujetos expresó su voluntad de donar material biológico, aunque el 60 % manifestó tener desconfianza en que sus muestras fueran usadas en algunos tipos de investigación, especialmente en clonación humana. Cerca de la mitad de los participantes refirieron saber qué era un biobanco, sin embargo, menos del 3 % tenía claridad suficiente sobre el concepto. Conclusión. Los participantes expresaron su disposición a donar y almacenar material biológico con fines de investigación, así como su opinión sobre algunos aspectos de la gestión de los biobancos. Las opiniones del público general se deben tener en cuenta en el desarrollo de políticas que regulen la actividad de los biobancos con fines de investigación en Colombia.

Introduction: Biobanks for research purposes are public assets that require active participation from all interested parties; therefore, it is important to discern and investigate the perception that the general public in Colombia has with regards to their participation in a biobank. Objective: To question different healthy Colombian social agents about the perception they have on donating human biological material to be stored in a biobank for future research purposes. Materials and methods: We conducted an exploratory quantitative and qualitative research by means of an anonymous survey on healthy members of the Colombian community in order to evaluate their knowledge and stances related to biobanks. Results: Three hundred sixty-eight (368) individuals completed the survey, including health-care researchers, lawyers and members of research ethics committees. Ninety-six percent (96%) of the subjects stated their willingness to donate biological material to biobanks, although 60% expressed distress about their samples being used for certain research activities, mainly human cloning. Even though about half of the participants reported knowing what a biobank is, less than 3% of the individuals had a clear concept of them. Conclusion: Participants showed their willingness to donate and store their biological material for research purposes. Similarly, they expressed their opinion about issues related to the management of biobanks. It is necessary to take into account the opinions of the general public in the development of policies that regulate biobanks for research purposes in Colombia.

Comparison of cervicovaginal cytopathological samples collected in basic health units and in private clinics in the midwest of Santa Catarina / Comparação de amostras citopatológicas cérvicovaginais coletadas nas unidades básicas de saúde e em clínicas privadas no meio-oeste de Santa Catarina

Abstract Objective To compare the quality of cervicovaginal samples obtained from basic health units (BHUs) of the Unified Health System (SUS) and those obtained fromprivate clinics to screen precursor lesions of cervical cancer. Methods It was an intervention study whose investigated variables were: adequacy of the samples; presence of epithelia in the samples, and cytopathological results. A total of 940 forms containing the analysis of the biological samples were examined: 470 forms of women attended at BHUs of the SUS and 470 forms of women examined in private clinics in January and February of 2016. Results All the unsatisfactory samples were collected at BHUs and corresponded to 4% of the total in this sector (p < 0.0001). There was a higher percentage of samples containing only squamous cells in the SUS (43.9%). There was squamocolumnar junction (SJC) representativeness in 82.1% of the samples from the private clinics (p < 0.0001). Regarding negative results for intraepithelial lesions and/or malignancies, the percentages obtained were 95.9% and 99.1% (p < 0.0049) in the exams collected in the private system and SUS, respectively. Less serious lesions corresponded to 0.89% of the samples from the SUS and 2.56% of the tests from the private sector; more serious lesions were not represented in the samples obtained from BHUs, whereas the percentage was 1.49% in private institutions. Conclusion Unsatisfactory cervical samples were observed only in exams performed at the SUS. There is a need for guidance and training of professionals who perform this procedure to achieve higher reliability in the results and more safety for women who undergo this preventive test.

Resumo Objetivo Comparar a qualidade das amostras cérvico-vaginais colhidas no Sistema Único de Saúde (SUS) e nas clínicas privadas para rastrear lesões precursoras de câncer do colo uterino. Métodos Estudo de intervenção cujas variáveis estudadas foram: adequabilidade da amostra, representação de epitélios na amostra, e resultado do exame citopatológico. Um total de 940 formulários contendo as análises das amostras biológicas foram examinados: 470 formulários de mulheres atendidas nas unidades básicas de saúde do SUS, e 470 formulários de mulheres atendidas em clínicas privadas no período de janeiro a fevereiro de 2016. Resultados Todas as amostras insatisfatórias foram coletadas nas unidades básicas de saúde do SUS e corresponderam a 4% do total neste setor (p < 0,0001). Observou-se um índice maior de amostras com representatividade somente de células escamosas no SUS (43,9%). Houve representatividade das células da junção escamo-colunar (JEC) em 82,1% das amostras colhidas no setor privado (p < 0,0001). Em relação aos resultados negativos para lesão intraepitelial e/ou malignidade, os percentuais obtidos foram 95,95% e 99,1% (p < 0,0049) para os exames coletados no sistema privado e no SUS, respectivamente. Em relação às lesões menos graves, no SUS obteve-se um resultado de 0,89% e no sistema privado de 2,56%; as lesões mais graves não foram diagnosticadas no SUS, enquanto que no setor privado representaram 1,49% dos exames. Conclusão As amostras cérvico-vaginais insatisfatórias foram observadas somente em exames realizados no SUS; há necessidade de orientação e capacitação dos profissionais que realizam a coleta do exame citopatológico, possibilitando uma maior confiabilidade nos resultados e mais segurança à mulher que se submete a este exame preventivo.

El Biobanco Institucional como pilar de las ciencias médicas / Institutional Biobank as a pillar of medical science

Resumen: Los biobancos constituyen puentes efectivos entre grupos de investigación básicos y clínicos para generar conocimientos y aplicaciones que eleven su competitividad internacional. Se revisaron las tareas realizadas y los logros alcanzados durante la implementación del Biobanco Institucional de la Universidad Autónoma de Nuevo León (UANL). Se abordó el equipamiento, entrenamiento del personal, aspectos bioéticos y regulatorios, y procesos de laboratorio y de gestión de calidad, entre otros. A partir del apoyo a más de una docena de proyectos de investigación, la inscripción de más de 3 000 individuos y la colecta, procesamiento y almacenamiento de casi 6 000 bioespecímenes, el Biobanco Institucional contribuye de manera importante a la integración de las actividades de asistencia, docencia e investigación básica y clínica del Hospital Universitario y de la Facultad de Medicina de la UANL. Se iniciaron planes para transitar del Biobanco Institucional hacia el Laboratorio Nacional.

Abstract: A biobank facility is one of the most valuable means that academic medical organizations have to offer researchers for improving the competitiveness of their medical research. We describe the implementation of our institutional biobank. Our efforts focused on the design and equipment of work areas, staff training, quality control, bioethical and regulatory issues, generating research collaborations and developing funding strategies. We implemented an institutional biobank at the School of Medicine of the Autonomous University of Nuevo León, Mexico. The biobank has supported more than a dozen research protocols with over 3 000 individuals enrolled and almost 6 000 sampled biospecimens stored. The institutional biobank has become an essential bridge and effective catalyst for research synergies between basic and clinical sciences and it is on its way to becoming a National Laboratory.

RePORT International: Advancing Tuberculosis Biomarker Research Through Global Collaboration.

Progress in tuberculosis clinical research is hampered by a lack of reliable biomarkers that predict progression from latent to active tuberculosis, and subsequent cure, relapse, or failure. Regional Prospective Observational Research in Tuberculosis (RePORT) International represents a consortium of regional cohorts (RePORT India, RePORT Brazil, and RePORT Indonesia) that are linked through the implementation of a Common Protocol for data and specimen collection, and are poised to address this critical research need. Each RePORT network is designed to support local, in-country tuberculosis-specific data and specimen biorepositories, and associated research. Taken together, the expected results include greater global clinical research capacity in high-burden settings, and increased local access to quality data and specimens for members of each network and their domestic and international collaborators. Additional networks are expected to be added, helping to spur tuberculosis treatment and prevention research around the world.

Delineamento e implementacao do biobanco do ELSA-Brasil: estudo prospectivo na populacao brasileira / Design and implementation of the ELSA-Brasil biobank: a prospective study in a Brazilian population

O Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) é uma coorte prospectiva multicêntrica de funcionários públicos delineada para avaliar os determinantes das doenças crônicas, principalmente a doença cardiovascular e o diabetes tipo 2. Neste artigo são descritos os principais pontos do delineamento e implementação do projeto do biobanco do ELSA-Brasil. São detalhados aspectos econômicos, políticos, logísticos e tecnológicos do estudo. O artigo também discute o protocolo final de estocagem de material biológico e as instalações implementadas para atingir esse objetivo. O processo de delineamento e implementação do biobanco do ELSA-Brasil durou três anos. Tanto os biobancos centrais quanto os locais foram constituídos de acordo com as melhores práticas de estocagem de material biológico, usando soluções tecnológicas diferentes para as diferentes necessidades previstas no estudo.

The Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) is a multicenter prospective cohort of civil servants designed to assess the determinants of chronic diseases, especially cardiovascular diseases and type 2 diabetes. The present article describes the main design and implementation points of the ELSA-Brasil biobank project. Economic, political, logistical and technological aspects of this study are characterized. Additionally, it discusses the final biorepository protocol and the facilities implemented to achieve this objective. The design and implementation process of the ELSA-Brasil biobank took three years to be performed. Both the central and local biobanks were built according to the best biorepository techniques, using different technological solutions for the distinct needs expected in this study.

Biobanking for health research in Brazil: present challenges and future directions / Bancos de materiales biológicos para la investigación en salud en el Brasil: retos actuales y perspectivas futuras

This article outlines and discusses Brazil's new regulations on the use of human biological materials for research, specifically, Resolution CNS 441/11, enacted by the National Health Council of Brazil in May 2011, and the National Guidelines for Biorepositories and Biobanks (Ordinance No. 2201) published by the Ministry of Health in September 2011. The authors examine the differences between sample collections for single studies and large-scale collections for multiple studies (e.g., the National Tumor Bank at the Brazilian National Cancer Institute and the A. C. Camargo Hospital Biobank). Also discussed are the ethical and operational implications, i.e.,informed consent process, strategies for sample collection, custodianship, access to samples, and rules for disposal. Insights gained may be useful for developing national biobanking regulations in other countries in Latin America.

En este artículo se describen y se analizan los nuevos reglamentos del Brasil -para el uso de materiales biológicos humanos para la investigación; específicamente, la Resolución CNS 441/11, sancionada por el Consejo Nacional de Salud del Brasil en mayo del 2011, y las Directrices Nacionales para Repositorios Biológicos y Bancos de Materiales Biológicos (Ordenanza Nº. 2201), publicadas por el Ministerio de Salud en septiembre del 2011. Los autores examinan las diferencias entre la recolección de muestras para un estudio único y la recolección en gran escala para múltiples estudios (por ejemplo, el Banco Nacional de Tumores del Instituto Nacional del Cáncer del Brasil y el Banco de Materiales Biológicos del Hospital A. C. Camargo). También se analizan las implicaciones éticas y operativas, como el proceso de consentimiento informado, las estrategias de obtención de las muestras, su custodia, el acceso a las muestras y las reglas para desecharlas. Estos conocimientos pueden ser útiles para establecer reglamentos nacionales para los bancos de materiales biológicos en otros países de América Latina.

Análise da manutenção de integridade estrutural de órgãos dentários e a influência de diferentes métodos de descontaminação e armazenamento / Analysis of the maintenance of structural integrity of dental organs and the influence of different methods of decontamination and storage

Este estudo teve como proposta analisar a efetividade e a influência de diferentes métodos de descontaminação e armazenamento de dentes humanos, visando à manutenção de suas propriedades e integridade estrutural. A amostra foi constituída por 126 molares hígidos recém-extraídos, cedidos ao Banco de Dentes Humanos da FOB-USP, que foram distribuídos de forma randômica em 4 grupos de acordo com o método de processamento empregado: controle - água destilada, timol a 0,1%, azida de sódio a 0,02% e autoclave. Foram realizados testes microbiológicos (07, 15 e 30 dias), de fluorescência a laser e de microdureza de superfície (0, 15 e 30 dias). A análise do teste microbiológico foi realizada de modo qualitativo (presença ou ausência de crescimento bacteriano) e quantitativo (frequências absolutas e relativas), enquanto nos testes de fluorescência a laser e microdureza de superfície houve a aplicação de Análise de Variância e teste de Tukey (p<0,05). Na análise microbiológica a autoclave foi o único método capaz de inibir o crescimento bacteriano, em todos os períodos. No teste de fluorescência a laser a solução de timol a 0,1% se mostrou mais viável na manutenção da integridade do órgão dentário, uma vez que não apresentou variações significativas nos valores de fluorescência a laser entre os tempos analisados (p>0,05). A análise de microdureza de superfície evidenciou a perda de estrutura dentária em todos os métodos utilizados, sendo que a azida de sódio permitiu uma menor perda de tecido dentário, entretanto este método promoveu perda de estrutura dentária nos espécimes entre o tempo 0 e 15 dias (de 440,20±19,75, para 247,40±21,09), e reendurecimento da superfície dentária entre o tempo 15 e 30 dias (276,93±13,37). Dentre os métodos de processamento analisados nenhum foi capaz de aliar a efetividade na descontaminação e no armazenamento com a manutenção da integridade estrutural dos órgãos dentários.

This study aimed to analyze the effectiveness and the influence of different methods of decontamination and storage of human teeth, in order to maintain their properties and structural integrity. The sample consisted of 126 recently extracted molars, assigned to the Human Teeth Bank of Bauru Dental School-University of São Paulo, which were distributed randomly into four groups according to the method of processing employed: control - distilled water, thymol 0.1%, sodium azide 0.02% and autoclave. The tests performed were Microbiological tests (7, 15 and 30 days), laser fluorescence and surface microhardness (0, 15 and 30 days). The analysis of microbiological test was performed qualitatively (presence or absence of bacterial growth) and quantitatively (absolute and relative frequencies), while on tests of laser fluorescence and surface microhardness were applied ANOVA and Tukey test (p <0.05). In the microbiological analysis the autoclave was the only method able to inhibit bacterial growth in all periods. In the laser fluorescence test thymol solution at 0.1% proved to be more viable in maintaining the integrity of the dental organ, since it did not show significant variations in the laser fluorescence values among the analyzed periods (p> 0.05). The surface microhardness analysis showed the tooth structure loss in all methods used, and sodium azide led to a smaller tooth tissue loss, however this method promoted the tooth structure loss in the specimens between 0 and 15 days (of 440.20 ± 19.75 to 247.40 ± 21.09), and the hardened tooth surface between 15 and 30 days (276.93 ± 13.37). Among the processing methods analyzed none was able to combine the effectiveness in the decontamination and storage with the maintenance of the structural integrity of the dental organs.

Tumor banks: the cornerstone of basic research in urology

PURPOSE: Tumor banks have the primary responsibility for collecting, cataloging, storing and disseminating samples of tissues, cells and fluids, which are used by researchers to identify diagnostic molecular markers, prognostic indicators and therapeutic targets. The objective of this review was to describe a simple, reliable and reproducible protocol for obtaining and storing samples of urological tumors. MATERIALS AND METHODS: Urogenital tumor tissues were collected by the surgeons from the Urology Division of University of Sao Paulo Medical School. The obtained surgical specimens were immediately placed in liquid nitrogen, dry ice or in a tube containing RNAlater ®, and then stored by cryopreservation (-80°C). A mirror fragment was fixed in 10 percent formalin processed routinely and embedded in Paraplast®. RESULTS: We developed a protocol for the collection, cataloging, storage, conservation and use of tumor samples. During a period of one year the Urological Tumor Bank of the Urology Division stored 274 samples of prostate, bladder, kidney, penis and testicle tumors of different histological types, 74 urine and 271 serum samples. CONCLUSIONS: Having biological materials characterized and available along with the clinical patient information provides an integrated portrait of the patients and their diseases facilitating advances in molecular biology. It also promotes the development of translational research improving methods of diagnosis and cancer treatment.