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The Role of the Mortuary
Published in Jason Payne-James, Suzy Lishman, The Medical Examiner Service, 2023
They have five options (the first three being statutory) open to them: Return the tissues to the body before the funeral (delay release of the body to a funeral director until such time as the tissues can be repatriated to the deceased)Retain the tissues as part of the medical record (hold the material in a biorepository for a period of 30 years as part of the deceased person's medical record at which time the tissues will be incinerated as clinical waste)Retain the tissues as part of the medical record and use them in ethically approved research (hold the material in a biorepository for a period of 30 years as part of the deceased person's medical record and make them available for ethically approved research bodies for that period, at which time the tissues will be incinerated as clinical waste)Hospital disposal (clinical incineration after the tissues have been used for their scheduled purpose)Return to me (return the tissues to the designated next of kin, sometimes even after the funeral. The tissues will be delivered in a safe condition to handle).
Clinical Clues, Biochemical Indices, and Biomarkers
Published in David J. Hackam, Necrotizing Enterocolitis, 2021
Karl G. Sylvester, Enrico Danzer
To address these clinical needs requires the derivation of new information through the study of human patients or thoroughly annotated patient biologic samples (e.g., tissue, blood, feces, urine) by state-of-the-art technologies (e.g., near-infrared spectroscopy, DNA sequencing, serum metabolomics, tissue transcriptomics), along with the utilization of computational methods combining established clinical risk factors and new data types. These studies will likely benefit from multi-institutional collaborations, as currently configured in the NEC Society Biorepository, and lend itself to the derivation of novel pathophysiologic insights as well as markers of disease according to the challenges described earlier (Figure 5.1).
“Kidney in a Dish” Organoids for PKD
Published in Jinghua Hu, Yong Yu, Polycystic Kidney Disease, 2019
Nelly M. Cruz, Benjamin S. Freedman
Notably, hPSC in the undifferentiated state are polarized, ciliated epithelial cells that endogenously express PKD1 and PKD2, providing quick and easy readouts for certain genotypic or phenotypic outcomes. To model PKD in organoids, we have established a cohort of hPSC with defined mutations in PKD-related genes including PKD1, PKD2, and PKHD1.7,8,10 Other laboratories have also established PKD hPSC from patient cells.26,27 In our experience, gene-edited cells are superior to patient-derived cells, and WA09 (H9) ES cells (WiCell) and WTC-11 iPS cells (Coriell Biorepository, GM25256) are optimal genetic backgrounds in which to perform most “PKD in a dish” experiments.10 In addition to PKD lines, it may also be useful to cultivate hPSC with mutations in non-PKD genes, as a negative control. For instance, PODXL−/− hPSC are gene edited in a similar way to the PKD lines but do not exhibit cystogenesis phenotypes, rather they express a defect in podocyte junctional migration.8,19
Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research priorities for ultra-rare inherited bleeding disorders
Published in Expert Review of Hematology, 2023
Diane Nugent, Suchitra S. Acharya, Kimberly J. Baumann, Camille Bedrosian, Rebecca Bialas, Kai Brown, Deya Corzo, Amar Haidar, Catherine P. M. Hayward, Peter Marks, Marzia Menegatti, Margaret E. Miller, Kate Nammacher, Roberta Palla, Skye Peltier, Rajiv K. Pruthi, Michael Recht, Benny Sørensen, Michael Tarantino, Alisa S. Wolberg, Amy D. Shapiro
Adequate infrastructure support is essential to all the centralized data collection, sample banking, expert network, and research collaboration initiatives identified. The important benefits of resource and expertise sharing may be most easily reaped between centers with similar foci, but are expected to extend throughout the network. A skilled workforce is needed to collect and expertly process samples, and for data entry. Centralized resources, such as a biorepository (potentially building upon the existing ATHN biorepository [73]) and a quality control or reagent standardization initiative, have the potential to improve diagnostic accuracy and reduce expenses. Expertise and funding will be required to design and execute complex molecular sample analyses (genotypes, epigenetics, genetic disease modifiers) evolving with technological advances. As explored in depth by WG6, workforce cross-training in innovative approaches to informatics, data science, epidemiology, and small clinical trial design will be key [57].
Profiling plasma extracellular vesicle by pluronic block-copolymer based enrichment method unveils features associated with breast cancer aggression, metastasis and invasion
Published in Journal of Extracellular Vesicles, 2018
Zhenyu Zhong, Matthew Rosenow, Nick Xiao, David Spetzler
Breast cancer and non-cancer samples were from Caris biorepository, age-match samples (average of 55 years old) were chosen (Figure 5(a)). Breast cancer samples were all from advanced clinical stage III and IV. All information regarding age and stage of the patients are listed in Supplement Table 1. Bio-specimens utilized in this experiment were obtained under an institutional review board (IRB)-approved Biorepository Protocol. All subjects were consented with an IRB approved consent form and per 21 CFR 50.20 guidelines. Blood was collected using standard venipuncture to ethylenediaminetetraacetic acid (EDTA) tubes and plasma was collected by standardized protocol and the centrifuges provided by Caris Life Sciences. Blood were then spun in the Labofuge 200 for 10 min at 5300 RPM to remove cell debris. The clear layer of the plasma was aliquoted and transferred into cryovials and store at −80°C until use. Before EV enrichment described in the following section, the plasma was quickly thawed in water at room temperature (RT) and centrifuged at 4000g for another 15 min at RT to further remove any potential protein aggregation/cell debris, clear supernatant of the plasma were then used for the EV enrichment. Plasma aliquots for the EV enrichment below were all freeze-thawed for only one time.
Grudging Trust and the Limits of Trustworthy Biorepository Curation
Published in The American Journal of Bioethics, 2018
Karen M. Meagher, Eric T. Juengst, Gail E. Henderson
Given the diversity of interests at stake, there is also a potential trade-off, as local trust could come at the cost of decreasing the overall reliability of curated data. More locally sensitive research efforts might garner community trust, yet set the stage for difficult trade-offs as larger biorepository networks face organizational needs to harmonize data sets, and secondary researchers explore research questions not originally envisioned when the specimens and data were collected. Responsive local research could present similar barriers unless care is taken to engage donors themselves on the issue of harmonization (Goldenberg and Brothers 2018). This barrier could be addressed through explicit community engagement projects explaining the need for harmonization, which could increase donor trust and also provide biorepositories with a more solid foundation for the rationale behind at least one form of community engagement. This approach would help remedy the uncertainty biorepositories confront regarding which community engagement approach to implement, and for what purposes (Haldeman, Cadigan and Davis 2014).