[National and world experience in functioning of centers for collective use of biological resource collections of tumors of the central nervous system]. / Analiz mirovogo i otechestvennogo opyta funktsionirovaniya tsentrov kollektivnogo pol'zovaniya bioresursnymi kollektsiyami opukholei tsentral'noi nervnoi sistemy.

Collective use center is an organization or structural unit with unique resource providing access to this resource for internal and third-party users. Collective use centers are a relatively new phenomenon in bioresource collections, especially collections of human biological material due to some ethical and legal issues. At the same time, the demand for human biological material continues to grow in fundamental and applied researches. The collective use center «Bioresource collection of tissues and cell cultures of tumors of the human nervous system for fundamental and applied researches¼ has worked since October 14, 2022. This center has access to unique collection of the Laboratory of Neurosurgical Anatomy and Conservation of Human Biological Tissues of the Burdenko Neurosurgical Center. OBJECTIVE: To analyze the experience of collective use center and biobank of the Burdenko Neurosurgical Center compared to national and international data on functioning of collective use centers specializing in tumors of the human central nervous system. MATERIAL AND METHODS: We reviewed the PubMed and e-Library databases using the following keywords: core facilities brain tumors, repository of collective use brain tumors, biobank of CNS tumors, central nervous system tumor collection centers. We also analyzed the organizations registered on the portal of scientific and technical infrastructure of the Russian Federation. RESULTS: We analyzed 275 publications devoted to collective use centers and biobanks. These biobanks do not position themselves as collective use centers but actively realize biological material for researches. Structure of institutions presented on the portal of scientific and technical infrastructure of the Russian Federation is characterized. The collective use center «Bioresource collection of tissues and cell cultures of tumors of the human nervous system for fundamental and applied researches¼ has access to biobank of the Burdenko Neurosurgical Center. To date, the biobank contains more than 8478 aliquots of tumor tissue frozen at ultra-low temperature (-196°C) and obtained from 1993 patients. Considering available data, we established the basic principles of work in collective use centers with bioresource collections. CONCLUSION: Collective use centers with bioresource collections of tumors of the central nervous system are rare. There is only one collective use center organized at the Burdenko Neurosurgical Center on the portal of scientific and technical infrastructure of the Russian Federation. At the same time, there is an urgent need to increase their number and activity in Russia and other countries worldwide. You can use the resource of brain tumor collections by leaving a request on the official website of this organization in the «Collective use center¼ section.

Guidelines for Biobanking of Bone Marrow Adipose Tissue and Related Cell Types: Report of the Biobanking Working Group of the International Bone Marrow Adiposity Society.

Over the last two decades, increased interest of scientists to study bone marrow adiposity (BMA) in relation to bone and adipose tissue physiology has expanded the number of publications using different sources of bone marrow adipose tissue (BMAT). However, each source of BMAT has its limitations in the number of downstream analyses for which it can be used. Based on this increased scientific demand, the International Bone Marrow Adiposity Society (BMAS) established a Biobanking Working Group to identify the challenges of biobanking for human BMA-related samples and to develop guidelines to advance establishment of biobanks for BMA research. BMA is a young, growing field with increased interest among many diverse scientific communities. These bring new perspectives and important biological questions on how to improve and build an international community with biobank databases that can be used and shared all over the world. However, to create internationally accessible biobanks, several practical and legislative issues must be addressed to create a general ethical protocol used in all institutes, to allow for exchange of biological material internationally. In this position paper, the BMAS Biobanking Working Group describes similarities and differences of patient information (PIF) and consent forms from different institutes and addresses a possibility to create uniform documents for BMA biobanking purposes. Further, based on discussion among Working Group members, we report an overview of the current isolation protocols for human bone marrow adipocytes (BMAds) and bone marrow stromal cells (BMSCs, formerly mesenchymal), highlighting the specific points crucial for effective isolation. Although we remain far from a unified BMAd isolation protocol and PIF, we have summarized all of these important aspects, which are needed to build a BMA biobank. In conclusion, we believe that harmonizing isolation protocols and PIF globally will help to build international collaborations and improve the quality and interpretation of BMA research outcomes.

Establishing a reproductive biorepository for basic and translational research: experience developing the reproductive subjects registry and sample repository.

PURPOSE: To report experience designing and establishing a reproductive registry and sample biorepository and to describe initial subject characteristics and biospecimens. METHODS: Beginning in December 2017, patients presenting for reproductive care at the University of Michigan were approached for study enrollment. Following consent, subjects completed detailed reproductive and health questionnaires. A variety of reproductive specimens and tissues were collected and processed for multiple downstream applications. RESULTS: Subject enrollment began in December of 2017. There are currently 1798 subjects enrolled. Female participants report a variety of reproductive disorders. Available samples include semen, sperm, follicular fluid, granulosa cells, immature oocytes, ovarian and uterine tissue, and blood samples. CONCLUSION: We report the successful establishment of a reproductive registry and sample biorepository. Furthermore, we describe methods for collection and storage of a variety of reproductive tissue processed for multiple downstream translational applications.

COllaborative Neuropathology NEtwork Characterizing ouTcomes of TBI (CONNECT-TBI).

Efforts to characterize the late effects of traumatic brain injury (TBI) have been in progress for some time. In recent years much of this activity has been directed towards reporting of chronic traumatic encephalopathy (CTE) in former contact sports athletes and others exposed to repetitive head impacts. However, the association between TBI and dementia risk has long been acknowledged outside of contact sports. Further, growing experience suggests a complex of neurodegenerative pathologies in those surviving TBI, which extends beyond CTE. Nevertheless, despite extensive research, we have scant knowledge of the mechanisms underlying TBI-related neurodegeneration (TReND) and its link to dementia. In part, this is due to the limited number of human brain samples linked to robust demographic and clinical information available for research. Here we detail a National Institutes for Neurological Disease and Stroke Center Without Walls project, the COllaborative Neuropathology NEtwork Characterizing ouTcomes of TBI (CONNECT-TBI), designed to address current limitations in tissue and research access and to advance understanding of the neuropathologies of TReND. As an international, multidisciplinary collaboration CONNECT-TBI brings together multiple experts across 13 institutions. In so doing, CONNECT-TBI unites the existing, comprehensive clinical and neuropathological datasets of multiple established research brain archives in TBI, with survivals ranging minutes to many decades and spanning diverse injury exposures. These existing tissue specimens will be supplemented by prospective brain banking and contribute to a centralized route of access to human tissue for research for investigators. Importantly, each new case will be subject to consensus neuropathology review by the CONNECT-TBI Expert Pathology Group. Herein we set out the CONNECT-TBI program structure and aims and, by way of an illustrative case, the approach to consensus evaluation of new case donations.

SARS-CoV-2/COVID-19 pandemic: first wave, impact, response and lessons learnt in a fully integrated Regional Blood and Tissue Bank. A narrative report.

BACKGROUND: The COVID-19 pandemic is placing blood and tissue establishments under unprecedented stress, putting its capacity to provide the adequate care needed at risk. Here we reflect on how our integrated organisational model has faced the first impact of the pandemic and describe what challenges, opportunities and lessons have emerged. MATERIALS AND METHODS: The organisational model of the Catalan Blood and Tissue Bank (Banc de Sang i Teixits, BST) is described. The new scenario was managed by following international recommendations and considering the pandemic in a context of volatility, uncertainty, complexity, and ambiguity (VUCA), allowing rapid measures to be taken. These aimed to: ensure donor safety, promote proper responses to patients' needs, ensure the health and well-being of personnel, and prepare for future scenarios. RESULTS: The BST has adapted its activities to the changes in demand. No shortage of any product or service occurred. Donor acceptance, safety and wellbeing were maintained except for tissue donation, which almost completely stopped. To support the health system, several activities have been promoted: large-scale convalescent plasma (CP) production, clinical trials with CP and mesenchymal stromal cells, massive COVID-19 diagnoses, and participation in co-operative research and publications. Haemovigilance is running smoothly and no adverse effects have been detected among donors or patients. DISCUSSION: Several elements have proven to be critical when addressing the pandemic scenario: a) the early creation of a crisis committee in combination with technical recommendations and the recognition of a VUCA scenario; b) identification of the strategies described; c) the integrated donor-to-patient organisational model; d) active Research and Development (R&D); and e) the flexibility of the staff. It is essential to underline the importance of the need for centralised management, effective contingency strategies, and early collaboration with peers.

Autism BrainNet: A Collaboration Between Medical Examiners, Pathologists, Researchers, and Families to Advance the Understanding and Treatment of Autism Spectrum Disorder.

CONTEXT.­: Autism spectrum disorder is a neurodevelopmental condition that affects over 1% of the population worldwide. Developing effective preventions and treatments for autism will depend on understanding the neuropathology of the disorder. While evidence from magnetic resonance imaging indicates altered development of the autistic brain, it lacks the resolution needed to identify the cellular and molecular underpinnings of the disorder. Postmortem studies of human brain tissue currently represent the only viable option to pursuing these critical studies. Historically, the availability of autism brain tissue has been extremely limited. OBJECTIVE.­: To overcome this limitation, Autism BrainNet, funded by the Simons Foundation, was formed as a network of brain collection sites that work in a coordinated fashion to develop a library of human postmortem brain tissues for distribution to researchers worldwide. Autism BrainNet has collection sites (or Nodes) in California, Texas, and Massachusetts; affiliated, international Nodes are located in Oxford, England and Montreal, Quebec, Canada. DATA SOURCES.­: Pubmed, Autism BrainNet. CONCLUSIONS.­: Because the death of autistic individuals is often because of an accident, drowning, suicide, or sudden unexpected death in epilepsy, they often are seen in a medical examiner's or coroner's office. Yet, autism is rarely considered when evaluating the cause of death. Advances in our understanding of chronic traumatic encephalopathy have occurred because medical examiners and neuropathologists questioned whether a pathologic change might exist in individuals who played contact sports and later developed severe behavioral problems. This article highlights the potential for equally significant breakthroughs in autism arising from the proactive efforts of medical examiners, pathologists, and coroners in partnership with Autism BrainNet.

Biobanking for necrotizing enterocolitis: Needs and standards.

BACKGROUND: Necrotizing enterocolitis (NEC) is a devastating gastrointestinal disease that primarily affects premature infants. Despite medical advances, mortality and morbidity from NEC are still unacceptably high. This is partly because of the lack of specific biomarkers and therapies for this disease. Availability of high-quality biological samples and the associated data from premature infants are key to advance our understanding of NEC, and for biomarker discovery and drug development. To that end, the NEC Society Biorepository was established with the goal of promoting studies in human infants through sharing specialized biospecimen and data procurement for NEC research. OBJECTIVE: In this review, we will discuss the required infrastructure for biobanks, discuss the importance of informatics management, and emphasize the logistical requirements for sharing specimens. Finally, we will discuss the mechanism for how tissues and material will be shared between the institutions. CONCLUSION: We have developed a state-of-the-art biobank for human infants to advance the field of NEC research. With the NEC Society Biorepository, we seek to facilitate and accelerate the basic and translational studies on NEC to provide hope to the infants afflicted with NEC and their families. STUDY TYPE: Review article, level V.

Single or double embryo transfer? Decision-making process in patients participating in an oocyte donation program.

In IVF/ICSI programs, after receiving the information about the success results of single embryo transfer (SET) vs double embryo transfer (DET) and the risks of multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable studies have been published in oocyte recipients. The aim of this study was to evaluate if the counseling provided to oocyte recipients influence their decision on the number of embryos to be transferred. Fifty-five recipients expressed their preference and the relevance for the decision-making process that they attribute to certain factors through an anonymous questionnaire completed pre and post-counseling. Before counseling, 32 out of 55 recipients preferred DET, 13 preferred SET and 10 were undecided. From the 32 recipients who preferred DET, 16 (50%) maintained their preference after counseling, 13 (40.6%) changed their decision to SET and 3 (9.4%) changed to undecided (McNemar's test: p < .05). After counseling, the patients attached less importance to the probability of pregnancy and more importance to maternal and perinatal risks (p < .05). We conclude that after counseling, a significant number of recipients changed their preferences from DET to SET.

Issues in the Use of Human Tissues to Support Precision Medicine.

Precision medicine is an approach in which the characteristics of patients as well as their diseases are used to identify optimal therapy; it links researchers, patients, health care providers, and clinical laboratories. In precision medicine, specific molecular characteristics of an untreatable cancer can be targeted by specific molecular-based therapy. Access to high-quality human tissues is necessary to determine many characteristics of patients and their diseases (such as targetable molecules). There are ethical issues in using human tissues in precision medicine, including informed consent and confidentiality, optimal utilization, quality of tissues, and minimization of bias. When human tissues are obtained for patient therapy, the bioresource should be a component certified by Clinical Laboratory Improvement Amendments. For precision medicine to benefit medically underserved populations requires extensive focused research, planning, and resources, some of which are currently unavailable at rural and other sites where care is provided to underserved populations.

Tailoring a rapid autopsy protocol to explore cancer evolution: a patient collaboration.

Genomic analysis of tissues from rapid autopsy programmes has transformed our understanding of cancer. However, these programmes are not yet established in New Zealand. Our neuroendocrine tumour research group, NETwork!, received a request from a patient wishing to donate tumour tissues post-mortem. This viewpoint article summarises the ethical, logistical and social process undertaken to accept this patient's generous donation, and highlights the scientific and educational value of such a gift.

Addressing Challenges in Converting Grant-Funded Infrastructures to Broadly Used Research Resources.

The NCI invests heavily in research resources to serve the research community, including datasets, biospecimen banks, and networks of institutions in which clinical trials and other human subjects research are conducted. These resources often begin as grant-funded infrastructure initiated by scientists based on their own scientific interests, with a subsequent recognition of additional scientific uses. Although converting existing project-specific research activities into research resources may appear efficient in terms of time and financial investment, challenges can arise that undermine this efficiency and jeopardize future use. Here, we describe three challenges in the conversion process: (i) project-based infrastructure versus a research resource for a broader research community; (ii) complexity versus ease of use; and (iii) individual professional goals versus research resource priorities. We use our experience with the NCI-funded Cancer Research Network, particularly the Virtual Data Warehouse, to illustrate each challenge, concluding with strategies to mitigate each one. As studies grow in size and complexity, an ever-increasing volume of data, biospecimens, and human subjects research networks will be available for conversion to resources for scientific questions beyond those originally proposed. Addressing likely challenges thoughtfully can result in a more efficient conversion process and ultimately greater scientific impact.

Making a national donor research program a reality: Concepts for operationalizing a system.

Deceased donor research remains an elusive goal for improving organ utilization and function. Many working in this field have cited the barriers that impede the conduct of such trials. Recent reports from the Academy of Medicine and individual authors provide a general framework on which a National Donor Research Program could be built. This paper provides one observer's viewpoint on how such a program could be operationalized.

Establishment of a biobank for human lung tissues of congenital diaphragmatic hernia and congenital pulmonary airway malformation.

BACKGROUND: Human tissue samples are an invaluable and little available source of information for translational studies of congenital lung diseases such as Congenital Diaphragmatic Hernia (CDH) or Congenital Pulmonary Airway Malformation (CPAM). PURPOSE: We aimed to establish a human lung tissue biobank of CDH and CPAM patients together with age-matched controls, coupled with a clinical database. METHODS: Pathology records from autopsies or surgical specimens for CDH and CPAM cases between 1980 and 2017 were reviewed. For surviving individuals, clinical patient data was obtained from corresponding pediatric surgery reports. Formalin-fixed, paraffin-embedded tissues of patients and age-matched controls were systematically stored for further translational studies. RNA integrity was determined on selected CDH blocks. RESULTS: A total of 16 CDH and 18 CPAM and age-matched control lung tissue blocks were included in our biobank. Ages ranged from 22 to 41 weeks of gestation (GA) in CDH (33.9 ±â€¯6.35 weeks) and 26 weeks (GA) and 12 years in CPAM (2.3 ±â€¯3.7 y). RNA isolation from CDH and control blocks yielded good RNA quality (OD 260/280 ratio: 2.01-2.09, OD 260/230 ratio: 2.04-2.09). CONCLUSION: We established a unique human biobank for CDH and CPAM tissues. The combination with clinical patient data will allow us to design future translational studies to improve our understanding of the disease pathogenesis of these congenital malformations.

The current status of oocyte banks: domestic and international perspectives.

Two major breakthroughs in the field of assisted reproduction-oocyte donation and oocyte vitrification-have joined forces to create the rapidly emerging phenomenon of commercial egg banks (CEBs). In this review, we examine the history of this concept, the operational models, the geographical variations, and the benefits and pitfalls of CEBs, including the ethical and legal dilemmas arising from gamete mobility. We highlight future directions in the brave new world of third-party reproduction.

Reliability of deceased-donor procurement kidney biopsy images uploaded in United Network for Organ Sharing.

Prior studies demonstrate poor agreement among pathologists' interpretation of kidney biopsy slides. Reliability of representative images of these slides uploaded to the United Network of Organ Sharing (UNOS) web portal for clinician review has not been studied. We hypothesized high agreement among pathologists' image interpretation, since static images eliminate variation induced by viewing different areas of movable slides. To test our hypothesis, we compared the assessments of UNOS-uploaded images recorded in standardized forms by three pathologists. We selected 100 image sets, each having at least two images from kidneys of deceased donors. Weighted Cohen's kappa was used for inter-rater agreement. Mean (SD) donor age was 50 (13). Acute tubular injury had kappas of 0.12, 0.14, and 0.19; arteriolar hyalinosis 0.16, 0.27, and 0.38; interstitial inflammation 0.30, 0.33, and 0.49; interstitial fibrosis 0.28, 0.32, and 0.67; arterial intimal fibrosis 0.34, 0.42, and 0.59; tubular atrophy 0.35, 0.41, and 0.52; glomeruli thrombi 0.32, 0.53, and 0.85; and global glomerulosclerosis 0.68, 0.70, and 0.77. Pathologists' agreement demonstrated kappas of 0.12 to 0.77. The lower values raise concern about the reliability of using images. Although further research is needed to understand how uploaded images are used clinically, the field may consider higher-quality standards for biopsy photomicrographs.

Update on the supply and use of allografts in locomotor system pathologies in France.

Allografts are increasingly used in orthopedics. The main aim of the present study was to map the use of locomotor system allografts in France between 2012 and 2016. The study hypothesis was that there are great differences in the distribution and activity of tissue banks and graft preservation procedure quality, failing to meet national requirements. MATERIAL AND METHODS: Data from activity reports of the French Biomedicine Agency (ABM) were collected for the period 2012-2016. Existing viral inactivation procedures were described. Preliminary results from a study of allograft requirements by the French Society of Arthroscopy (SFA) were reported. RESULTS: Nineteen tissue banks were located. Four dealt exclusively with cryopreserved tissue, 3 exclusively with virus-inactivated bone, and 12 with both. Distribution analysis found wide disparities in geographic location and in type of activity. Viral inactivation is presently implemented only for femoral heads derived from hip replacement. Stocks of long bones, femoral heads and ligaments/tendons increased constantly over the study period, by 8.3%, 50.8% and 316.2% respectively. The SFA questionnaire confirmed a serious shortage of tissues, necessitating importation of allografts. DISCUSSION: Each tissue bank had its own specificities and specialization. They should probably be coalesced, so as to centralize both supply and demand and improve nationwide response to requirements. Locomotor system tissue harvesting also needs to be expanded to meet increasing demand.