Organization of Hannover Skin Bank: Sterile culture and procurement protocols for viable cryopreserved allogeneic skin grafts of living donors.

Preserved allogeneic donor skin still represents one of the gold standard therapies in temporary wound coverage in severely burned patients or chronic wounds. Allogeneic skin grafts are currently commercially available as cryo- or glycerol-preserved allografts through skin tissue banks all over the world. Most of the skin tissue banks rely on human cadaveric skin donations. Due to the chronic shortage of human allogeneic transplants, such as skin, and increasing costs in the procurement of allografts from other skin tissue banks, Hannover Medical School has been building up its own skin tissue bank based on allogeneic skin grafts from living donors who underwent surgical treatment (i.e., body-contouring procedures, such as abdominioplasties). This article presents procedures and protocols for the procurement and processing of allogeneic skin grafts according to national legislation and European regulations and guidelines. Beside protocols, initial microbiological data regarding the sterility of the harvested grafts are presented. The results currently form the basis for further investigations as well as clinical applications. In summary, a microbiological testing and acceptance procedure is presented that ensures adequate patient safety and skin viability.

Effects of donor source on transcriptomic profiles of human kidney tissue.

Normal human tissue is a critical reference control in biomedical research. However, the type of tissue donor can significantly affect the underlying biology of the samples. We investigated the impact of tissue donor source type by performing transcriptomic analysis on healthy kidney tissue from three donor source types: cadavers, organ donors, and normal-adjacent tissue from surgical resections of clear cell renal cell carcinomas, and we compared the gene expression profiles to those of clear cell renal cell carcinoma samples. Comparisons among the normal samples revealed general similarity, with notable differences in gene expression pathways involving immune system and inflammatory processes, response to extracellular stimuli, ion transport, and metabolism. When compared to tumors, the transcriptomic profiles of the normal adjacent tissue were highly similar to the profiles from cadaveric and organ donor tissue samples, arguing against the presence of a field cancerization effect in clear cell renal cell carcinoma. We conclude that all three normal source types are suitable for reference kidney control samples, but important differences must be noted for particular research areas and tissue banking strategies.

Establishment of a diverse head and neck squamous cancer cell bank using conditional reprogramming culture methods.

Most laboratory models of head and neck squamous cell cancer (HNSCC) rely on established immortalized cell lines, which carry inherent bias due to selection and clonality. We established a robust panel of HNSCC tumor cultures using a "conditional reprogramming" (CR) method, which utilizes a rho kinase inhibitor (Y-27632) and co-culture with irradiated fibroblast (J2 strain) feeder cells to support indefinite tumor cell survival. Sixteen CR cultures were successfully generated from 19 consecutively enrolled ethnically and racially diverse patients with HNSCC at a tertiary care center in the Bronx, NY. Of the 16 CR cultures, 9/16 were derived from the oral cavity, 4/16 were derived from the oropharynx, and 3/16 were from laryngeal carcinomas. Short tandem repeat (STR) profiling was used to validate culture against patient tumor tissue DNA. All CR cultures expressed ΔNp63 and cytokeratin 5/6, which are markers of squamous identity. Human papillomavirus (HPV) testing was assessed utilizing clinical p16 staining on primary tumors, reverse transcription polymerase chain reaction (RT-PCR) of HPV16/18-specific viral oncogenes E6 and E7 in RNA extracted from tumor samples, and HPV DNA sequencing. Three of four oropharyngeal tumors were p16 and HPV-positive and maintained HPV in culture. CR cultures were able to establish three-dimensional spheroid and murine flank and orthotopic tongue models. CR methods can be readily applied to all HNSCC tumors regardless of patient characteristics, disease site, and molecular background, providing a translational research model that properly includes patient and tumor diversity.

The Netherlands Heart Tissue Bank : Strengthening the cardiovascular research infrastructure with an open access Cardiac Tissue Repository.

AIM: Cardiac diseases remain a leading cause of cardiovascular disease (CVD) related hospitalisation and mortality. That is why research to improve our understanding of pathophysiological processes underlying cardiac diseases is of great importance. There is a strong need for healthy and diseased human cardiac tissue and related clinical data to accomplish this, since currently used animal and in vitro disease models do not fully grasp the pathophysiological processes observed in humans. This design paper describes the initiative of the Netherlands Heart Tissue Bank (NHTB) that aims to boost CVD-related research by providing an open-access biobank. METHODS: The NHTB, founded in June 2020, is a non-profit biobank that collects and stores biomaterial (including but not limited to myocardial tissue and blood samples) and clinical data of individuals with and without previously known cardiac diseases. All individuals aged ≥ 18 years living in the Netherlands are eligible for inclusion as a potential future donor. The stored samples and clinical data will be available upon request for cardiovascular researchers. CONCLUSION: To improve the availability of cardiac tissue for cardiovascular research, the NHTB will include extensive (cardiac) biosamples, medical images, and clinical data of donors with and without a previously known cardiac disease. As such, the NHTB will function as a translational bridge to boost a wide range of cardiac disease-related fundamental and translational studies.

Biobancos en los servicios de anatomía patológica en Costa Rica: un análisis bioético y biojurídico

Objetivo: Analizar el marco bioético y biojurídico en relación con los biobancos en los servicios de anatomía patológica. Métodos: Revisión bibliográfica descriptiva de información relevante sobre la bioética y bioderecho en relación con los biobancos en los servicios de anatomía patológica, en donde se contemplaron las normativas, decretos y leyes nacionales e internacionales relacionadas con los biobancos y las bases de datos; se consultaron diferentes libros de texto utilizando el catálogo público del Sistema de Bibliotecas, Documentación e Información de la Universidad de Costa Rica y plataformas como PubMed y Google Académico. Resultados: Con el avance de la medicina en el desarrollo de nuevas técnicas terapéuticas y diagnósticas, surge una nueva herramienta de gran interés científico a nivel internacional: el establecimiento de biobancos de tejidos para conservar muestras biológicas utilizadas en estudios moleculares e investigación. Esto trajo consigo una cantidad de cuestionamientos de índole bioético y biojurídico relevantes relacionados con los derechos humanos y el respeto a la dignidad humana. Para establecer un biobanco en un departamento de anatomía patológica es indispensable conocer, manejar e implementar lo estipulado por las normativas nacionales e internacionales referente al consentimiento informado y la protección de los datos vinculados a los bioespecímenes. Conclusiones: Para utilizar en investigación los bioespecímenes que se encuentran en los departamentos de anatomía patológica debe seguirse lo que estipulan las normas y directrices nacionales e internacionales que regulan el manejo, uso y almacenamiento de las muestras, el consentimiento informado, la protección y la confidencialidad de los datos relacionados a las personas involucradas en los estudios biomédicos. En Costa Rica el marc ético-jurídico relacionado a la investigación biomédica regula el uso de los bioespecímenes en ensayos clínicos, pero no existe una legislación nacional específica en materia de biobancos, se recomienda que se establezca una ley con su respectivo reglamento en donde se visualicen todos los requerimientos de un biobanco a nivel público y privado.

Aim: To analyze the bioethical and bio juridical framework regarding biobanks in the Pathology Departments. Methods: Descriptive bibliographical revision of relevant information regarding bioethics and bio law with focus on the pathological anatomy services. Local laws, international laws and normative linked to biobanks and data bases were taken into consideration. Text books from the Universidad de Costa Rica`s Library, Documentation and Information System were consulted and also digital platforms as Academic Google and PubMed. Results: A new tool of scientific interest has emerged internationally with the medical advancement in the development of new therapeutic and diagnostic techniques: the establishment of tissue biobanks to preserve biological samples for molecular studies and research. This brought with it a number of questions relevant to bioethics and biolaw related to human rights and the respect for human dignity. In order to establish a biobank in a pathological anatomy department, it is essential to know, how to manage and implement the national and international regulations related to informed consent and the protection of data linked to biological samples. Conclusions: National and international guidelines for using biological samples stored in pathology departments for research purposes must be followed. They must regulate the management, use and storage of samples. Also, the informed consent and the protection and confidentiality of the data regarding the incumbent people in biomedical research must be take into consideration. In Costa Rica, the ethical and juridical framework related to the biomedical research establishes the parameters of biospecimens in clinical rehearsals but there is not a national legislation regarding biobanks. Because of that, is that is recommended a regulation that must include all the requirements for a biobank either in the public and private spectrum; such as a national law and formal regulation.

It's the Biology Orthopods! Heralding a Reconstructive Revolution Through Musculoskeletal Tissue Banks (MSTB) in India.

Background: A tissue bank is an establishment that aids in retrieval, processing, storage, and distribution  of human tissue for transplantation. For many years, such banks have been dispensing tissue to orthopaedic surgeons, performing reconstructive surgeries. Methodology: The retrieval, preparation, and delivery of musculoskeletal tissue used for transplantation is an intricate process  involving varying practices among different musculoskeletal tissue banks. Results: Musculoskeletal allografts are used in various orthopaedic surgeries ranging from primary bone defects, trauma, and carcinoma to congenital disabilities. Every decade brings in paradigm shifts and new hope for treating challenging cases with the aid of newer devices and materials. Conclusion: This review article outlines various technical, regulatory and quality enhancement steps involved in tissue banking. Also, it discusses the road ahead and the research avenues for developing novel allograft products with the synergy of tissue banks and clinicians. Supplementary Information: The online version contains supplementary material available at 10.1007/s43465-022-00661-0.

Biobancos: conservación del patrimonio científico de la humanidad

Un biobanco permite mantener en condiciones óptimas y de manera organizada las colecciones de muestras biológicas con los más altos estándares de calidad, éticos y legales, con fines de investigación biomédica que genere nuevo conocimiento, así como aplicaciones de docencia. Los avances en biomedicina y el desarrollo de tecnologías, han facilitado el acceso a la información y esto debe aplicarse en pro de un mejor aprovechamiento de las muestras biológicas, en la comprensión de las bases inmunopatogénicas de las enfermedades, que finalmente lleve a proponer estrategias de detección, prevención, promoción y tratamiento. El Laboratorio de Dermatopatología de la Sección de Dermatología de la Facultad de Medicina de la Universidad de Antioquia, ha procesado más de 57.000 biopsias desde su fundación, conservando los archivos clínicos, registros fotográficos, placas y bloques histopatológicos, otorgándole un gran potencial como biobanco. Esta revisión narrativa de la literatura tiene como objetivo ilustrar una visión general de la importancia del desarrollo de los biobancos, así como los aspectos a tener en cuenta en su estructuración.

Summary A biobank allows the collections of biological samples to be maintained in optimal conditions and in an organized manner with the highest quality, ethical and legal standards, for biomedical research purposes that generate new knowledge, as well as teaching applications. Advances in biomedicine and the development of technologies have facilitated access to information and this should comply in favor of a better use of biological samples in the understanding of the immunopathogenic bases of diseases, which finally carry out a proposing strategies of detection, prevention, promotion and treatment. The Dermatopathology Laboratory of the Dermatology Section of the Faculty of Medicine of the University of Antioquia has processed more than 57,000 biopsies since its foundation, preserving the clinical files, photographic records, plates and histopathological blocks, giving it great potential as a biobank. This narrative review of the literature aims to illustrate an overview of the importance of the development of biobanks, as well as the aspects to take into account in their structuring.

The use of biological membranes for correction of congenital malformations.

Many congenital malformations often require a multidisciplinary and multistep surgical treatment, including the use of biological membranes. Aims of the study were to describe the use of these membranes for the correction of malformations, their clinical performance at follow-up, and patient's tolerance to them. The study included patients treated between 2009 and November 2020 in two referral centers. They were affected by abdominal wall defects (AWD), esophageal atresia/tracheo-esophageal fistula (EA/TEF), diaphragmatic hernia (CDH), spinal defects (SD), and anorectal malformations (ARM). The human origin membranes used during surgery were amniotic membrane, fascia lata, and pericardium provided by the local tissue bank and the porcine-derived membrane available on the market. Thirty-one patients were retrieved. The sample included 10 AWD, 7 EA/TEF, 5 CDH, 4 SD, 2 ARM, and 3 miscellaneous defects. The median age at repair was 139 days (range: 10,5-1494). The median follow-up was 1021 days (range: 485,5-1535). Two patients were lost at follow-up. The defects were successfully repaired and the membranes perfectly tolerated in 28/29 cases. In 1 case of CDH the fascia lata was replaced with a Goretex patch due to recurrence of the defect. This is the largest series on the use of biological membranes in congenital malformations. The variety of tissues allows to choose the best material for each malformation. The excellent tolerance and performance of this first series of patients encourage the use of these membranes to correct different type of malformations at any age.

Barriers to the Development and Sustainability of Bone Banking Programs in Low- and Middle-Income Countries: A Systematic Review.

Purpose: The number of bone allograft transplantations required in low- and middle-income countries (LMICs) is growing very quickly. No previous study has investigated the challenges clinical banks face to sustain operations or meet this demand. The purpose of this study was to conduct a systematic review of the barriers to implementation and sustainability of clinical bone tissue banks in LMICs. Barriers identified in clinical bone banking can shed light on strategies for overcoming obstacles in other biobanking programs. Methods: A systematic review protocol was registered with PROSPERO under identification number CRD42019136045. LMIC was defined using World Bank criteria. A search strategy targeting PubMed, Cumulative Index of Nursing and Allied Health Literature (CINAHL), and the World Health Organization (WHO) Global Health Library was used. Studies from the inception of bone banking until June 4, 2019, that discussed an identifiable barrier to bone banking were included. Study quality was assessed using The Critical Appraisals Skills Programme (CASP) Qualitative Checklist. Results: Of studies identified, 33 studies were included in the final analysis. Based on the full-text review, the primary barriers identified were lack of regulation, low donor rates, and insufficient training and staffing. CASP analysis performed on the 24 qualitative articles showed an average of 3.6 qualitative measurements met. Conclusions: As international organizations such as the International Atomic Energy Agency (IAEA) restructure their participation in global bone banking regulation, these barriers such as lack of regulation, low donor rates, and insufficient training and staffing could pose a challenge to meeting the rising demand for bone transplantation in LMICs. Articles with higher quality evidence are needed to better define barriers and propose evidence-based solutions.

Cooperative approach of pathology and neuropathology in the COVID-19 pandemic : German registry for COVID-19 autopsies (DeRegCOVID) and German network for autopsies in pandemics (DEFEAT PANDEMIcs).

BACKGROUND: Autopsy is an important tool for understanding the pathogenesis of diseases, including COVID-19. MATERIAL AND METHODS: On 15 April 2020, together with the German Society of Pathology and the Federal Association of German Pathologists, the German Registry of COVID-19 Autopsies (DeRegCOVID) was launched ( www.DeRegCOVID.ukaachen.de ). Building on this, the German Network for Autopsies in Pandemics (DEFEAT PANDEMIcs) was established on 1 September 2020. RESULTS: The main goal of DeRegCOVID is to collect and distribute de facto anonymized data on potentially all autopsies of people who have died from COVID-19 in Germany in order to meet the need for centralized, coordinated, and structured data collection and reporting during the pandemic. The success of the registry strongly depends on the willingness of the respective centers to report the data, which has developed very positively so far and requires special thanks to all participating centers. The rights to own data and biomaterials (stored decentrally) remain with each respective center. The DEFEAT PANDEMIcs network expands on this and aims to strengthen harmonization and standardization as well as nationwide implementation and cooperation in the field of pandemic autopsies. CONCLUSIONS: The extraordinary cooperation in the field of autopsies in Germany during the COVID-19 pandemic is impressively demonstrated by the establishment of DeRegCOVID, the merger of the registry of neuropathology (CNS-COVID19) with DeRegCOVID and the establishment of the autopsy network DEFEAT PANDEMIcs. It gives a strong signal for the necessity, readiness, and expertise to jointly help manage current and future pandemics by autopsy-derived knowledge.

Appraising 5 years in activity of the largest public Canadian vascular graft bank.

BACKGROUND: In Canada, tissue distribution is managed by provincial entities. In 2014, Hema-Quebec established a cryopreserved vascular tissue bank accessible to all Canadian hospitals. The objectives of this report were to review the first 5 years of activity of Hema-Quebec's vascular bank and to briefly assess the competitiveness of its products. METHODS: Deceased donors, ages 15 to 60, were screened for common blood-borne diseases. Grafts were treated in a triple-antibiotic solution at 35°C before preservation at -100°C. Hema-Quebec's vascular graft records were analyzed from 2014 to 2019 inclusively. RESULTS: The average donor age was 35 years old and 78% of donors were men. Overall, 63% of harvested grafts cleared the quality management system. Positive microbial cultures and morphologic defects were the major reasons for graft discard. As such, a total of 60 grafts were delivered between 2016 and 2019 to 8 hospital centers. Moreover, the bank achieved a mean activity increase of 55% per year and Hema-Quebec's homografts were 48% less costly compared with similar homographs from for-profit organizations. CONCLUSIONS: Our findings demonstrate that Hema-Quebec has established a viable cryopreserved vascular tissue bank with steady increase in activity and an acceptable graft discard rates and pricing. Based on our findings, we recommend that efforts should be directed to expand the tissue bank graft distribution outside the province of Quebec.

[Cooperative approach of pathology and neuropathology in the COVID-19 pandemic : German registry for COVID-19 autopsies (DeRegCOVID) and German network for autopsies in pandemics (DEFEAT PANDEMIcs)]. / Kooperatives Vorgehen der Pathologie und Neuropathologie in der COVID-19-Pandemie : Deutsches Register für COVID-19-Obduktionen (DeRegCOVID) und Deutsches Netzwerk für Autopsien in Pandemien (DEFEAT PANDEMIcs).

BACKGROUND: Autopsy is an important tool for understanding the pathogenesis of diseases, including COVID-19. MATERIAL AND METHODS: On 15 April 2020, together with the German Society of Pathology and the Federal Association of German Pathologists, the German Registry of COVID-19 Autopsies (DeRegCOVID) was launched ( www.DeRegCOVID.ukaachen.de ). Building on this, the German Network for Autopsies in Pandemics (DEFEAT PANDEMIcs) was established on 1 September 2020. RESULTS: The main goal of DeRegCOVID is to collect and distribute de facto anonymized data on potentially all autopsies of people who have died from COVID-19 in Germany in order to meet the need for centralized, coordinated, and structured data collection and reporting during the pandemic. The success of the registry strongly depends on the willingness of the respective centers to report the data, which has developed very positively so far and requires special thanks to all participating centers. The rights to own data and biomaterials (stored decentrally) remain with each respective center. The DEFEAT PANDEMIcs network expands on this and aims to strengthen harmonization and standardization as well as nationwide implementation and cooperation in the field of pandemic autopsies. CONCLUSIONS: The extraordinary cooperation in the field of autopsies in Germany during the COVID-19 pandemic is impressively demonstrated by the establishment of DeRegCOVID, the merger of the registry of neuropathology (CNS-COVID19) with DeRegCOVID and the establishment of the autopsy network DEFEAT PANDEMIcs. It gives a strong signal for the necessity, readiness, and expertise to jointly help manage current and future pandemics by autopsy-derived knowledge.

Fertility preservation for prepubertal boys: lessons learned from the past and update on remaining challenges towards clinical translation.

BACKGROUND: Childhood cancer incidence and survivorship are both on the rise. However, many lifesaving treatments threaten the prepubertal testis. Cryopreservation of immature testicular tissue (ITT), containing spermatogonial stem cells (SSCs), as a fertility preservation (FP) option for this population is increasingly proposed worldwide. Recent achievements notably the birth of non-human primate (NHP) progeny using sperm developed in frozen-thawed ITT autografts has given proof of principle of the reproductive potential of banked ITT. Outlining the current state of the art on FP for prepubertal boys is crucial as some of the boys who have cryopreserved ITT since the early 2000s are now in their reproductive age and are already seeking answers with regards to their fertility. OBJECTIVE AND RATIONALE: In the light of past decade achievements and observations, this review aims to provide insight into relevant questions for clinicians involved in FP programmes. Have the indications for FP for prepubertal boys changed over time? What is key for patient counselling and ITT sampling based on the latest achievements in animals and research performed with human ITT? How far are we from clinical application of methods to restore reproductive capacity with cryostored ITT? SEARCH METHODS: An extensive search for articles published in English or French since January 2010 to June 2020 using keywords relevant to the topic of FP for prepubertal boys was made in the MEDLINE database through PubMed. Original articles on fertility preservation with emphasis on those involving prepubertal testicular tissue, as well as comprehensive and systematic reviews were included. Papers with redundancy of information or with an absence of a relevant link for future clinical application were excluded. Papers on alternative sources of stem cells besides SSCs were excluded. OUTCOMES: Preliminary follow-up data indicate that around 27% of boys who have undergone testicular sampling as an FP measure have proved azoospermic and must therefore solely rely on their cryostored ITT to ensure biologic parenthood. Auto-transplantation of ITT appears to be the first technique that could enter pilot clinical trials but should be restricted to tissue free of malignant cells. While in vitro spermatogenesis circumvents the risk linked to cancer cell contamination and has led to offspring in mice, complete spermatogenesis has not been achieved with human ITT. However, generation of haploid germ cells paves the way to further studies aimed at completing the final maturation of germ cells and increasing the efficiency of the processes. WIDER IMPLICATIONS: Despite all the research done to date, FP for prepubertal boys remains a relatively young field and is often challenging to healthcare providers, patients and parents. As cryopreservation of ITT is now likely to expand further, it is important not only to acknowledge some of the research questions raised on the topic, e.g. the epigenetic and genetic integrity of gametes derived from strategies to restore fertility with banked ITT but also to provide healthcare professionals worldwide with updated knowledge to launch proper multicollaborative care pathways in the field and address clinical issues that will come-up when aiming for the child's best interest.

[A clinical radiological score for femoral head grafts : Establishment of the Tabea FK score to ensure the quality of human femoral head grafts]. / Ein klinisch-radiologischer Score für Femurkopftransplantate : Etablierung des Tabea-FK-Scores zur Sicherung der Qualität humaner Femurkopftransplantate.

INTRODUCTION: Transplantation of cancellous tissue from human femoral heads (FK) is an established method in the reconstruction of bony defects in orthopedic and trauma surgery. Standardized rating systems with respect to the morphological quality of this tissue are not available. MATERIALS AND METHODS: In 91/105 patients who had been a regular, clinically-indicated surgery (arthroplasty of the hip joint) the respective femoral head (FK) was taken under standardized conditions. Using a checklist defined clinical and radiological criteria of FK are judged in terms of their quality (cysts, necrosis, calcification, deformities, osteoporosis) and divided by the Tabea FK score into three classes (best/middle/poor quality). This was followed by a blinded repeated scoring, now as macroscopic assessment of three sawed layers from the same femoral head. The femoral heads are examined by peripheral quantitative computed tomography (pQCT) and a standardized histological examination of the bony tissue. We evaluated the accordance of the Tabea FK score with complementary assessments by calculation of sensitivity and specificity. RESULTS: Femoral heads from 91/105 patients (ages: 68.4 ± 9.9 , n = 60 women, n = 31 men) were explanted and included in the study. The correlation between the primary radiologic clinical score (Tabea FK score) and the macroscopic second review of the sawn FK with respect to middle/best and poor/middle quality was classified as good (sensitivity 77% and 81%, respectively; specificity 76% and 84%, respectively). The correlation of histology and macroscopic second review was worse and in relation to discrimination of middle/best and poor/middle quality had a sensitivity of 85% and 54%, respectively, and a specificity of 66% and 97%, respectively. The pQCT showed a sensitivity of 82% only in discrimination of middle/best, while sensitivity in discrimination of poor/middle and poor/middle + best, respectively, was <10%. DISCUSSION: The corresponding correlation between the primary and the second clinical score was evaluated as good. This emphasizes the long-standing skills of operationally active orthopedic surgeons to classify the quality of cancellous bone correctly already on the basis of X­ray images and intraoperative findings. In this respect, the introduction of the Tabea FK score as a quality assurance tool in the routines of bone banks can be recommended.

Situación actual de los bancos de tejidos en Colombia: tejido cardiovascular / An update on cardiovascular tissue banks in Colombia

Resumen Introducción: ¿Cuál es la situación actual técnica y productiva de los cuatro bancos que están certificados en buenas prácticas para tejido cardiovascular en Colombia si se comparan con estándares internacionales? Objetivo: Caracterizar la capacidad técnica y la actividad de los bancos certificados del país para tejido cardiovascular durante el periodo de tiempo 2014 a 2016. Metodología: Mediante una encuesta realizada por vía teleconferencia a cada banco, se evaluaron ítems de donación, extracción, procesamiento, almacenamiento, distribución y capacidad de producción de los tejidos cardiovasculares. La información referida por las instituciones fue complementada con actas de certificación de buenas prácticas del INVIMA y la suministrada por el INS de las estadísticas reportadas por los mismos bancos durante el periodo 2014 a 2016. Resultados: El tejido cardiovascular procesado por los bancos colombianos procede principalmente de donantes con muerte encefálica y es extraído directamente en el quirófano; la edad de los donantes va desde recién nacidos hasta los 60 años. Cuando se requiere, el antibiótico de elección es la vancomicina. El almacenamiento más usado es la criopreservación y su distribución se hace principalmente a grupos quirúrgicos preestablecidos e intrainstitucionales. Conclusiones: El desarrollo del banqueo de este tipo de tejido está muy rezagado en Colombia respecto a otros países, debido a las dificultades de donación, extracción y utilización por grupos con alta experticia; adicionalmente, la normativa utilizada para evaluar estas instituciones está muy desactualizada.

Abstract Introduction: A study is performed to determine if the current technical and productive situation of the four cardiovascular tissue banks that have Good Practice Certificates in Colombia compare with international standards. Objective: To determine the technical capacity and activity of the banks certified by the country for cardiovascular tissue during the period from 2014 to 2016. Methodology: The items analysed using a questionnaire completed by teleconference to each bank were, donation, extraction, processing, storage, distribution, and production capacity of the cardiovascular tissues. The information provided by the institutions was complemented with the Minutes of Good Practice Certification of the Colombia National Food and Drug Surveillance Institute (INVIMA) as well as the statistics reported by the banks themselves and provided by the National Health Institute (INS) during the period 2014 to 2016. Results: The cardiovascular tissue processed by Colombian tissue banks mainly comes from donors with brain death, and is extracted directly in the operating theatre. The age of the donors go from newborn up to 60 years-old. When used, the antibiotic of choice is vancomycin. The most used storage method is cryopreservation, and is mainly distributed to established and institutional surgical groups. Conclusions: The development of this type of tissue bank is lagging behind in Colombia compared to other countries. This is due to the difficulties in donation, extraction, and use by groups with high expertise. Furthermore, the guidelines used to evaluate these institutions are very out of date.

Cardiovascular biobanks.

Los biobancos son instalaciones de insumos que promueven la investigación biomédica y fomentan la salud, ya que reciben, preservan, conservan y almacenan diversas muestras biológicas patológicas. Su implementación debería considerarse una acción estratégica para favorecer la producción científica y el desarrollo del conocimiento útil para proponer y aportar soluciones a problemas de salud.Biobanks are supply facilities that promote biomedical research and health by receiving, preserving, preserving, and storing various pathological biological samples. Its implementation should be considered a strategic action to favor scientific production and the development of useful knowledge to propose and develop solutions to health problems.

Characterization of Decellularized Human Pericardium for Tissue Engineering and Regenerative Medicine Applications / Caracterização do Pericárdio Humano Descelularizado para Engenharia de Tecidos e Aplicações de Medicina Regenerativa

Abstract Background: Pericardium tissue allograft can be used for surgical repair in several procedures. One of the tissue engineering strategies is the process of decellularization. This process decreases immunogenic response, but it may modify the natural extracellular matrix composition and behavior. Objective: The aim of this study was to evaluate the effectiveness of cell removal, maintenance of extracellular matrix properties and mechanical integrity of decellularized human pericardium using a low concentration solution of sodium dodecyl sulfate. Methods: Decellularization was performed with sodium dodecyl sulfate and ethylenediaminetetraacetic acid. Histological analysis, DNA quantification, evaluation of glycosaminoglycans and collagen were performed. Biomechanical assay was performed using tensile test to compare the decellularization effects on tissue properties of tensile strength, elongation and elastic modulus. P < 0.05 was considered significant. Results: There was reduction in visible nuclei present in pericardium tissue after decellularization, but it retained collagen and elastin bundles similar to fresh pericardium. The DNA contents of the decellularized pericardium were significantly reduced to less than 511.23 ± 120.4 ng per mg of dry weight (p < 0.001). The biomechanical assay showed no significant difference for fresh or decellularized tissue. Conclusion: The decellularization process reduces cell content as well as extracellular matrix components without changing its biomechanical properties.

Resumo Fundameto: O enxerto de pericárdio pode ser usado em muitos procedimentos de correção cirúrgica. Uma das estratégias da engenharia tecidual é o processo de descelularização. No entanto, embora esse processo diminua a resposta imunogênica, a descelularização pode modificar tanto o comportamento como a composição da matriz extracelular natural. Objetivos: Avaliar a eficácia da descelularização usando baixa concentração de dodecil sulfato de sódio na remoção celular, na manutenção das propriedades da matriz extracelular e na integridade mecânica do pericárdio humano descelularizado. Métodos: A descelularização foi realizada com dodecil sulfato de sódio e ácido etilenodiamino tetra-acético. Foi realizada análise histológica, quantificação de DNA, e avaliação de glicosaminoglicanos e colágeno. O estudo biomecânico foi conduzido pelo teste de tração para comparar os efeitos da descelularização sobre as propriedades teciduais de resistência à tração, alongamento e módulo de elasticidade. Foi considerado um valor de p < 0,05 como estatisticamente significativo. Resultados: Observou-se uma redução na quantidade de núcleos presentes no pericárdio após a descelularização, apesar de manter quantidades similares de feixes de elastina e de colágeno. As concentrações de DNA do pericárdio descelularizado foram significativamente reduzidas para menos que 511,23 ± 120,4 ng por mg de peso seco (p < 0,001). O teste biomecânico não apontou diferenças entre os tecidos fresco e descelularizado. Conclusão: A descelularização reduziu a concentração de células bem como os componentes da matriz extracelular sem afetar suas propriedades biomecânicas.

Secondary Use of Patient Tissue in Cancer Biobanks.

BACKGROUND: As scientific techniques evolve, historical informed consent forms may inadequately address modern research proposals, leading to ethical questions regarding research with archived biospecimens. SUBJECTS, MATERIALS, AND METHODS: We conducted focus groups among patients with cancer recruited from Massachusetts General Hospital to explore views on medical research, biobanking, and scenarios based on real biospecimen research dilemmas. Our multidisciplinary team developed a structured focus group guide, and all groups were recorded and transcribed. Transcripts were coded for themes by two independent investigators using NVivo software. RESULTS: Across five focus groups with 21 participants, we found that most participants were supportive of biobanks and use of their own tissue to advance scientific knowledge. Many favor allowing research beyond the scope of the original consent to proceed if recontact is impossible. However, participants were not comfortable speaking for other patients who may oppose research beyond the original consent. This was viewed as a potential violation of participants' rights or interests. Participants were also concerned with a "slippery slope" and potential scientific abuse if research were permitted without adherence to original consent. There was strong support for recontact and reconsent when possible and for the concept of broad consent at the time of tissue collection. CONCLUSION: Our participants support use of their tissue to advance research and generally support any productive scientific approach. However, in the absence of broad initial consent, when recontact is impossible, a case-by-case decision must be made regarding a proposal's potential benefits and harms. Many participants support broad use of their tissue, but a substantial minority object to use beyond the original consent. IMPLICATIONS FOR PRACTICE: For prospective studies collecting tissue for future research, investigators should consider seeking broad consent, to allow for evolution of research questions and methods. For studies using previously collected tissues, researchers should attempt recontact and reconsent for research aims or methods beyond the scope of the original consent. When reconsent is not possible, a case-by-case decision must be made, weighing the scientific value of the biobank, potential benefits of the proposed research, and the likelihood and nature of risks to participants and their welfare interests. This study's data suggest that many participants support broad use of their tissue and prefer science to move forward.

Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review.

Background: During the past few decades there has been a growing interest on the part of many governments in the creation of biobanks. Nevertheless, this would be impossible without participation of many donors who offer samples of their biological material for scientific research. Therefore, the aim of this paper is to provide an overview of the existing research on social attitudes towards biobanking. Material and Methods: A literature search was conducted in the database of MEDLINE (PubMed). 61 papers were included in the analysis. The retrieved articles were assessed using a thematic analysis. Results: Eight main themes were identified: (1) public knowledge about biobanks, (2) public views on biobanking, (3) willingness to donate, (4) donors' motivations, (5) perceived benefits and risks of biobanking, (6) preferred type of consent, (7) trust toward biobanks, and (8) demographic characteristics of potential donors. Conclusions: Although the public lacks knowledge about biobanking, many individuals declare willingness to donate. Their will is influenced by: their knowledge about biobanking, the type of donated tissue, research purpose, concerns over the safety of the data, preferred type of consent, and trust towards biobanks.