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- Reiner, A. T., et al.
(författare)
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Concise Review: Developing Best-Practice Models for the Therapeutic Use of Extracellular Vesicles
- 2017
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Ingår i: Stem Cells Translational Medicine. - : Oxford University Press (OUP). - 2157-6564 .- 2157-6580. ; 6:8
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Forskningsöversikt (refereegranskat)abstract
- Growing interest in extracellular vesicles (EVs, including exosomes and microvesicles) as therapeutic entities, particularly in stem cell-related approaches, has underlined the need for standardization and coordination of development efforts. Members of the International Society for Extracellular Vesicles and the Society for Clinical Research and Translation of Extracellular Vesicles Singapore convened a Workshop on this topic to discuss the opportunities and challenges associated with development of EV-based therapeutics at the preclinical and clinical levels. This review outlines topic-specific action items that, if addressed, will enhance the development of best-practice models for EV therapies.
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- Johannsson, Gudmundur, 1960, et al.
(författare)
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Safety and convenience of once-weekly somapacitan in adult GH deficiency: A 26-week randomized, controlled trial
- 2018
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Ingår i: European Journal of Endocrinology. - 0804-4643 .- 1479-683X. ; 178:5, s. 491-499
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin®. Local tolerability and treatment satisfaction were also assessed. Design: 26-week randomized, controlled phase 3 safety and tolerability trial in six countries (NCT02382939). Methods: Male or female patients aged 18–79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n=61) or once-daily Norditropin (n=31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range, and then administered at a fixed dose. Outcome measures were adverse events (AEs), including injection site reactions; occurrence of anti-somapacitan/anti-GH antibodies and change in treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Results: Mean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin (P=0.0171). Conclusions: In this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin. © 2018 European Society of Endocrinology Printed in Great Britain.
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- Ackermann, M., et al.
(författare)
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THE SPECTRUM AND MORPHOLOGY OF THE FERMI BUBBLES
- 2014
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Ingår i: Astrophysical Journal. - 0004-637X .- 1538-4357. ; 793:1, s. 64-
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Tidskriftsartikel (refereegranskat)abstract
- The Fermi bubbles are two large structures in the gamma-ray sky extending to 55 degrees above and below the Galactic center. We analyze 50 months of Fermi Large Area Telescope data between 100MeV and 500 GeV above 10 degrees in Galactic latitude to derive the spectrum and morphology of the Fermi bubbles. We thoroughly explore the systematic uncertainties that arise when modeling the Galactic diffuse emission through two separate approaches. The gamma-ray spectrum is well described by either a log parabola or a power law with an exponential cutoff. We exclude a simple power law with more than 7 sigma significance. The power law with an exponential cutoff has an index of 1.9 +/- 0.2 and a cutoff energy of 110 +/- 50 GeV. We find that the gamma-ray luminosity of the bubbles is 4.4(-0.9)(+2.4) x 10(37) erg s(-1). We confirm a significant enhancement of gamma-ray emission in the southeastern part of the bubbles, but we do not find significant evidence for a jet. No significant variation of the spectrum across the bubbles is detected. The width of the boundary of the bubbles is estimated to be 3.4(-2.6)(+3.7) deg. Both inverse Compton (IC) models and hadronic models including IC emission from secondary leptons fit the gamma-ray data well. In the IC scenario, synchrotron emission from the same population of electrons can also explain the WMAP and Planck microwave haze with a magnetic field between 5 and 20 mu G.
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- Clayton, Aled, et al.
(författare)
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Summary of the ISEV workshop on extracellular vesicles as disease biomarkers, held in Birmingham, UK, during December 2017
- 2018
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Ingår i: Journal of Extracellular Vesicles. - : Wiley. - 2001-3078. ; 7
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- © 2018 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group on behalf of The International Society for Extracellular Vesicles. This report summarises the presentations and activities of the ISEV Workshop on extracellular vesicle biomarkers held in Birmingham, UK during December 2017. Among the key messages was broad agreement about the importance of biospecimen science. Much greater attention needs to be paid towards the provenance of collected samples. The workshop also highlighted clear gaps in our knowledge about pre-analytical factors that alter extracellular vesicles (EVs). The future utility of certified standards for credentialing of instruments and software, to analyse EV and for tracking the influence of isolation steps on the structure and content of EVs were also discussed. Several example studies were presented, demonstrating the potential utility for EVs in disease diagnosis, prognosis, longitudinal serial testing and stratification of patients. The conclusion of the workshop was that more effort focused on pre-analytical issues and benchmarking of isolation methods is needed to strengthen collaborations and advance more effective biomarkers.
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- Lötvall, Jan, 1956, et al.
(författare)
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Minimal experimental requirements for definition of extracellular vesicles and their functions: a position statement from the International Society for Extracellular Vesicles.
- 2014
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Ingår i: Journal of extracellular vesicles. - : Wiley. - 2001-3078. ; 3
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Secreted membrane-enclosed vesicles, collectively called extracellular vesicles (EVs), which include exosomes, ectosomes, microvesicles, microparticles, apoptotic bodies and other EV subsets, encompass a very rapidly growing scientific field in biology and medicine. Importantly, it is currently technically challenging to obtain a totally pure EV fraction free from non-vesicular components for functional studies, and therefore there is a need to establish guidelines for analyses of these vesicles and reporting of scientific studies on EV biology. Here, the International Society for Extracellular Vesicles (ISEV) provides researchers with a minimal set of biochemical, biophysical and functional standards that should be used to attribute any specific biological cargo or functions to EVs.
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- Tran, C. -T, et al.
(författare)
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A study on transient heat transfer of the EU-ABWR external core catcher using the Phase-change Effective Convectivity Model
- 2015
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Ingår i: International Topical Meeting on Nuclear Reactor Thermal Hydraulics 2015, NURETH 2015. - : American Nuclear Society. - 9781510811843 ; , s. 6821-6834
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Konferensbidrag (refereegranskat)abstract
- In advanced designs of Nuclear Power Plants (NPPs), for mitigation of severe accident consequences, on the one hand, the In-Vessel Retention (IVR) concept has been implemented. On the other hand in other new NPP designs (Generation HI and III+) with large power reactors, the External Core Catcher (ECC) has been widely adopted. Assessment of ECC design robustness is largely based on analysis of heat transfer of a melt pool formed in the ECC. Transient heat transfer analysis of an ECC is challenging due to (i) uncertainty in the in-vessel accident progression and subsequent vessel failure modes; (ii) long transient, (iii) high Rayleigh number and complex flows involving phase change of the melt pool formed in an ECC. The present paper is concerned with analysis of transient melt pool heat transfer in the ECC of new Advanced Boiling Water Reactor (ABWR) designed by Toshiba Corporation (Japan). According to the ABWR severe accident management strategy, the ECC is initially dry. In order to prevent steam explosion flooding is initiated after termination of melt relocation from the vessel. The ECC full of melt is cooled from the top directly by water and from the bottom through the ECC walls. In order to assess sustainability of the ECC, heat transfer simulation of a stratified melt pool formed in the ECC is carried out. The problem addressed in this work is heat flux distribution at ECC boundaries when cooling is applied (i) from the bottom, (ii) from the top and from the bottom. To perform melt pool heat transfer simulation, we employ Phase-change Effective Convectivity Model (PECM) which was originally developed as a computationally efficient, sufficiently accurate, 2D/3D accident analysis tools for simulation of transient melt pool heat transfer in the reactor lower plenum. Thermal loads from the melt pool to ECC boundaries are determined for selected ex-vessel accident scenarios. Performance of the ECC, efficiency of severe accident management (SAM) measures and procedures are evaluated based on results of PECM simulation and severe accident analysis.
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