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The Food and Drug Administration (FDA) has been regulating human islets for allotransplantation as a biologic drug in the US. Consequently, the requirement of a biological license application (BLA) approval before clinical use of islet transplantation as a standard of care procedure has stalled the development of the field for the last 20 years. Herein, we provide our commentary to the multiple FDA's position papers and guidance for industry arguing that BLA requirement has been inappropriately applied to allogeneic islets, which was delivered to the FDA Cellular, Tissue and Gene Therapies Advisory Committee on 15 April 2021. We provided evidence that BLA requirement and drug related regulations are inadequate in reassuring islet product quality and potency as well as patient safety and clinical outcomes. As leaders in the field of transplantation and endocrinology under the "Islets for US Collaborative" designation, we examined the current regulatory status of islet transplantation in the US and identified several anticipated negative consequences of the BLA approval. In our commentary we also offer an alternative pathway for islet transplantation under the regulatory framework for organ transplantation, which would address deficiencies of in current system.

Having played at Highbury Stadium since 1913, Arsenal Football Club (Arsenal) moved a mere 500 metres to their new Emirates Stadium in 2006. In conforming to a contemporary 'concrete bowl' design, the new stadium lacked architectural distinctiveness. It also lacked the deeply emotional memories made over the years that meant Highbury was seen as 'hallowed turf'. To embed a sense of history and heritage into the new stadium, Arsenal embarked on a process of place-making they described as 'Arsenalisation' which employs design-led graphic heritage within and around the space. Drawing on observation, visual analysis and interdisciplinary literature research, this article focuses on the impact of these interventions in supporters' place-making and place attachment. It discusses the impact of graphic heritage on matchday rituals; the engagement of existing supporters and the initiation of new fans in Arsenal's history; and the use of graphic heritage in re-establishing a local sense of place. [ABSTRACT FROM AUTHOR]

As a 'spectacular' sporting heritage space Wembley Stadium and its setting have been recently celebrated after a centenary of sport and entertainment since its inauguration in 1923. This paper examines the recent redevelopment and design of Wembley Stadium in Wembley Park to depict how the heritage credentials of the area and the intangible nature of sport as performance are mediated through multiple graphic images and permanent, semi-permanent, and ephemeral graphic interventions. The morphological milieu of Wembley as a heritage place is shown to be the most tangible heritage asset upon which its heritage credentials stand, amongst numerous graphic images and objects that impact how people navigate and understand the visitor experience of Wembley as a contemporary place to visit, work, and live. [ABSTRACT FROM AUTHOR]

BackgroundAll human islets used in research and for the clinical treatment of diabetes are subject to ischemic damage during pancreas procurement, preservation, and islet isolation. A major factor influencing islet function is exposure of pancreata to cold ischemia during unavoidable windows of preservation by static cold storage (SCS). Improved preservation methods may prevent this functional deterioration. In the present study, we investigated whether pancreas preservation by gaseous oxygen perfusion (persufflation) better preserved islet function versus SCS.MethodsHuman pancreata were preserved by SCS or by persufflation in combination with SCS. Islets were subsequently isolated, and preparations in each group matched for SCS or total preservation time were compared using dynamic glucose-stimulated insulin secretion as a measure of β-cell function and RNA sequencing to elucidate transcriptomic changes.ResultsPersufflated pancreata had reduced SCS time, which resulted in islets with higher glucose-stimulated insulin secretion compared to islets from SCS only pancreata. RNA sequencing of islets from persufflated pancreata identified reduced inflammatory and greater metabolic gene expression, consistent with expectations of reducing cold ischemic exposure. Portions of these transcriptional responses were not associated with time spent in SCS and were attributable to pancreatic reoxygenation. Furthermore, persufflation extended the total preservation time by 50% without any detectable decline in islet function or viability.ConclusionsThese data demonstrate that pancreas preservation by persufflation rather than SCS before islet isolation reduces inflammatory responses and promotes metabolic pathways in human islets, which results in improved β cell function.

Prominent design discourse or advocacy in the domain of "design thinking" rarely depicts graphic design consistently or with sufficient rigor and understanding about the field's role in the development of design studies. Nor do most advocates for graphic design proffer it to be little more than a vernacular activity when competing for academic attention, despite its widespread academic presence, industry prominence, and everyday practice. The arguments presented here offer a timely critical perspective on a frequently unchallenged prevailing discourse that has echoed consistent assumptions over several decades. We call for more integrity in respect for those who design in different communication contexts, more precision in discussing how graphic design has evolved and been portrayed, and more rigor in the thoroughness and care that research into graphic design and its associated fields demands. The outcomes will be of particular interest to researchers who draw on and re-present Buchanan's four orders of design concept and offer an alternative perspective to those who suggest graphic design relies overly on intuition when deliberating on design thinking. [ABSTRACT FROM AUTHOR]

This paper reports on a project that explored the possibilities for utilizing graphic heritage as a tool to help UNESCO designations managers and their stakeholders better interpret their heritage in light of sustainable development challenges in urban environments sensitive to heritage. With the eventual goal to inform policy-making that benefits from a closer understanding between design and heritage, five phases are outlined. These employ several methods resulting in two important ways for graphic heritage to enhance the management of urban heritage contexts with possible future implications for UNESCO-designated Creative Cities, World Heritage Sites, and Biosphere Reserves. These contextualize the intrinsic and extrinsic nature of graphic heritage for UNESCO designations, and a scoping study for Bradford UNESCO City of Film features with several objectives outlining the basis for future research, collaboration, and wider dissemination. [ABSTRACT FROM AUTHOR]

Captive insectivore nutrition is challenging due to the differing nutritional profiles of wild and captive diets and an incomplete understanding of both. Ultraviolet B (UVB)-irradiation has recently been explored as a means of improving prey-insect vitamin D3 and Ca content. Although short-term irradiation has been successful in some species, it has been unsuccessful in black field crickets (Gryllus bimaculatus)—a commonly cultured feeder insect. We exposed crickets to UVB irradiation from hatchling to adult stages and measured the vitamin D3 and mineral contents of crickets by sex. We did not detect vitamin D3 (detection limit 0.5 iU/g) or an effect of UVB irradiation on mineral content under either UV+ or UV− conditions. We identified large differences between sexes in Ca, K, Mg and P (females higher) and Cu, Fe, S and Zn (males higher), likely linked to reproductive investment. The differences do not straddle the minimum recommended concentrations of minerals for vertebrate growth and thus may be most relevant to animal nutrition in contexts of particular sensitivity or need. We demonstrate a UV-linked trade-off in cricket performance between individual cricket size and the numbers of crickets produced and characterise the energy costs associated with UVB provision. Our results do not support the use of UVB lighting for G. bimaculatus to improve nutrition but demonstrate previously unreported differences in the nutritional profiles between sexes in this species. [ABSTRACT FROM AUTHOR]