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Article: Preliminary Assessment of Safety and Tolerability of Avacopan During the Early Access Program for ANCA-Associated Vasculitis.

van Leeuwen, Jolijn R / Popov, Tamara / Obergfell, Achim / Rabelink, Ton J / Teng, Y K Onno

2023 Volume 17, Page(s) 11–14

Language	English
Publishing date	2023-01-25
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2415708-9
ISSN	1177-5491 ; 1177-5475
ISSN (online)	1177-5491
ISSN	1177-5475
DOI	10.2147/BTT.S394843
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Article ; Online: Efficient Vascularization of Kidney Organoids through Intracelomic Transplantation in Chicken Embryos.

Koning, Marije / Lievers, Ellen / Jaffredo, Thierry / van den Berg, Cathelijne W / Rabelink, Ton J

Journal of visualized experiments : JoVE

2023 , Issue 192

Abstract: Kidney organoids derived from human induced pluripotent stem cells contain nephron-like structures that resemble those in the adult kidney to a certain degree. Unfortunately, their clinical applicability is hampered by the lack of a functional ... ...

Abstract	Kidney organoids derived from human induced pluripotent stem cells contain nephron-like structures that resemble those in the adult kidney to a certain degree. Unfortunately, their clinical applicability is hampered by the lack of a functional vasculature and consequently limited maturation in vitro. The transplantation of kidney organoids in the celomic cavity of chicken embryos induces vascularization by perfused blood vessels, including the formation of glomerular capillaries, and enhances their maturation. This technique is very efficient, allowing for the transplantation and analysis of large numbers of organoids. This paper describes a detailed protocol for the intracelomic transplantation of kidney organoids in chicken embryos, followed by the injection of fluorescently labeled lectin to stain the perfused vasculature, and the collection of transplanted organoids for imaging analysis. This method can be used to induce and study organoid vascularization and maturation to find clues for enhancing these processes in vitro and improve disease modeling.
MeSH term(s)	Chick Embryo ; Adult ; Animals ; Humans ; Chickens ; Induced Pluripotent Stem Cells ; Kidney ; Nephrons ; Kidney Glomerulus ; Neovascularization, Pathologic
Language	English
Publishing date	2023-02-17
Publishing country	United States
Document type	Journal Article ; Video-Audio Media ; Research Support, Non-U.S. Gov't
ZDB-ID	2259946-0
ISSN	1940-087X ; 1940-087X
ISSN (online)	1940-087X
ISSN	1940-087X
DOI	10.3791/65090
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Article ; Online: Immunostimulatory Profile of Cancer Cell Death by the AdV-Lumc007-Derived Oncolytic Virus 'GoraVir' in Cultured Pancreatic Cancer Cells.

Bots, Selas T F / Landman, Sanne L / Rabelink, Martijn J W E / van den Wollenberg, Diana J M / Hoeben, Rob C

Viruses

2023 Volume 15, Issue 2

Abstract: Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive malignancy which shows unparalleled therapeutic resistance. Oncolytic viruses have emerged as a new treatment approach and convey their antitumor activity through lysis of cancer cells. The ... ...

Abstract	Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive malignancy which shows unparalleled therapeutic resistance. Oncolytic viruses have emerged as a new treatment approach and convey their antitumor activity through lysis of cancer cells. The therapeutic efficacy of oncolytic viruses is largely dependent on the induction of immunogenic cell death (ICD) and the subsequent antitumor immune responses. However, the concurrent generation of antiviral immune responses may also limit the a virus' therapeutic window. GoraVir is a new oncolytic adenovirus derived from the Human Adenovirus B (HAdV-B) isolate AdV-lumc007 which was isolated from a gorilla and has demonstrated excellent lytic activity in both in vitro and in vivo models of PDAC. In this study, we characterized the immunostimulatory profile of cancer cell death induced by GoraVir and the concerted cellular antiviral responses in three conventional pancreatic cancer cell lines. While GoraVir was shown to induce late apoptotic/necrotic cell death at earlier time points post infection than the human adenovirus type 5 (HAdV-C5), similar levels of ICD markers were expressed. Moreover, GoraVir was shown to induce ICD not dependent on STING expression and regardless of subsequent antiviral responses. Together, these data demonstrate that GoraVir is an excellent candidate for use in oncolytic virotherapy.
MeSH term(s)	Humans ; Oncolytic Viruses ; Pancreatic Neoplasms/therapy ; Cell Death ; Adenoviridae/genetics ; Carcinoma, Pancreatic Ductal/therapy ; Adenoviruses, Human ; Antiviral Agents ; Pancreatic Neoplasms
Chemical Substances	Antiviral Agents
Language	English
Publishing date	2023-01-19
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v15020283
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Article ; Online: Ultrastructural characterization of maturing iPSC-derived nephron structures upon transplantation.

Wiersma, L E / Avramut, M C / Koster, A J / van den Berg, C W / Rabelink, T J

Microscopy research and technique

2023 Volume 87, Issue 3, Page(s) 495–505

Abstract: Pluripotent stem cell-derived kidney organoids hold great promise as a potential auxiliary transplant tissue for individuals with end-stage renal disease and as a platform for studying kidney diseases and drug discovery. To establish accurate models, it ... ...

Abstract	Pluripotent stem cell-derived kidney organoids hold great promise as a potential auxiliary transplant tissue for individuals with end-stage renal disease and as a platform for studying kidney diseases and drug discovery. To establish accurate models, it is crucial to thoroughly characterize the morphological features and maturation stages of the cellular components within these organoids. Nephrons, the functional units of the kidney, possess distinct morphological structures that directly correlate with their specific functions. High spatial resolution imaging emerges as a powerful technique for capturing ultrastructural details that may go unnoticed with other methods such as immunofluorescent imaging and scRNA sequencing. In our study, we have applied software capable of seamlessly stitching virtual slides generated from electron microscopy, resulting in high-definition overviews of tissue slides. With this technology, we can comprehensively characterize the development and maturation of kidney organoids when transplanted under the renal capsule of mice. These organoids exhibit advanced ultrastructural developments upon transplantation, including the formation of the filtration barrier in the renal corpuscle, the presence of microvilli in the proximal tubule, and various types of cell sub-segmentation in the connecting tubule similarly to those seen in the adult kidney. Such ultrastructural characterization provides invaluable insights into the structural development and functional morphology of nephron segments within kidney organoids and how to advance them by interventions such as a transplantation. Research Highlights High-resolution imaging is crucial to determine morphological maturation of hiPSC-derived kidney organoids. Upon transplantation, refined ultrastructural development of nephron segments was observed, such as the development of the glomerular filtration barrier.
MeSH term(s)	Animals ; Mice ; Induced Pluripotent Stem Cells ; Cell Differentiation ; Nephrons/metabolism ; Kidney/ultrastructure ; Pluripotent Stem Cells
Language	English
Publishing date	2023-11-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099714-3
ISSN	1097-0029 ; 1059-910X
ISSN (online)	1097-0029
ISSN	1059-910X
DOI	10.1002/jemt.24447
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Article ; Online: The addition of the sFlt-1/PlGF ratio to the protein/creatinine ratio in multiple pregnancy: Post-hoc analysis of the PREPARE cohort study.

Wind, M / Dekker, L / van den Akker-van Marle, M E / Ballieux, B E P B / Cobbaert, C M / Rabelink, T J / van Lith, J M M / Teng, Y K O / Sueters, M

Pregnancy hypertension

2024 Volume 36, Page(s) 101111

Abstract: Objective: To assess the predictive accuracy of the sFlt-1/PlGF ratio cut-off 38 in addition to the standard-of-care spot urine protein/creatinine ratio (PCr) for multiple pregnancies in women with suspected pre-eclampsia.: Study design: Post-hoc ... ...

Abstract	Objective: To assess the predictive accuracy of the sFlt-1/PlGF ratio cut-off 38 in addition to the standard-of-care spot urine protein/creatinine ratio (PCr) for multiple pregnancies in women with suspected pre-eclampsia. Study design: Post-hoc analysis of a prospective cohort study. Main outcome measures: Primary outcome was the occurrence of pre-eclampsia in one and four weeks after presentation with suspected pre-eclampsia. Test characteristics with 95% confidence intervals (CI) were calculated on pre-eclampsia development in one and four weeks. Results: Twenty-three multiple pregnancies with suspected pre-eclampsia between 20 and 37 weeks gestation were included for analysis. Women who eventually developed pre-eclampsia had a significantly higher PCr (34.0 vs. 16.5, p = 0.015), sFlt-1 (17033 vs. 5270 pg/ml, p = 0.047) and sFlt-1/PlGF ratio (99 vs. 25, p = 0.033) at baseline. Furthermore, PCr ≥ 30 and sFlt-1/PlGF ratio > 38 was respectively seen in 1/16 (6.3 %) and 3/16 (18.8 %) of the women who did not develop pre-eclampsia. For predicting pre-eclampsia within one week the sFlt-1/PlGF ratio sensitivity was 75.0 % [95 % CI 19.4-99.4] and the negative predictive value 93.8 % [73.0-98.8], while no pre-eclampsia developed when PCr was < 30. Consequently, the combination of these tests did not lead to an improvement in test characteristics, with non-significant differences in positive predictive value (50.0 % [29.5-70.5] versus 80.0 % [37.3-96.4]) compared to PCr alone for pre-eclampsia development in one week. Conclusions: In addition to standard-of-care spot urine PCr measurements, this study has not been able to demonstrate that the sFlt-1/PlGF ratio cut-off 38 is of added value in the prediction of pre-eclampsia in multiple pregnancy. Trial registration: Netherlands Trial Register (NL8308).
Language	English
Publishing date	2024-02-21
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2584464-7
ISSN	2210-7797 ; 2210-7789
ISSN (online)	2210-7797
ISSN	2210-7789
DOI	10.1016/j.preghy.2024.101111
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Article ; Online: Role of dietary interventions on microvascular health in South-Asian Surinamese people with type 2 diabetes in the Netherlands: A randomized controlled trial.

van der Velden, Anouk I M / IJpelaar, Daphne H T / Chandie Shaw, Prataap K / Pijl, Hanno / Vink, Hans / van der Vlag, Johan / Rabelink, Ton J / van den Berg, Bernard M

Nutrition & diabetes

2024 Volume 14, Issue 1, Page(s) 17

Abstract: Background/objectives: We investigated whether dietary interventions, i.e. a fasting mimicking diet (FMD, Prolon®) or glycocalyx mimetic supplementation (Endocalyx: Subjects/methods: A randomized, placebo controlled, 3-arm intervention study was ... ...

Abstract	Background/objectives: We investigated whether dietary interventions, i.e. a fasting mimicking diet (FMD, Prolon®) or glycocalyx mimetic supplementation (Endocalyx Subjects/methods: A randomized, placebo controlled, 3-arm intervention study was conducted in 56 SA-T2DM patients between 18 and 75 years old, for 3 consecutive months, with one additional follow up measurement 3 months after the last intervention. Sublingual microcirculation was assessed with SDF-imaging coupled to the GlycoCheck Results: Despite a temporal improvement in BMI and HbA1c after FMD the major treatment effect on microvascular health was worsening for RBC-velocity independent PBR Conclusions: We showed that despite temporal beneficial changes in BMI and HbA1c after FMD, this intervention is not able to preserve microvascular endothelial health in Dutch South-Asian patients with T2DM. In contrast, glycocalyx mimetics preserves the microvascular endothelial health and reduces the inflammatory cytokine MCP-1. Clinical study registration: NCT03889236.
MeSH term(s)	Humans ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Aged ; Diabetes Mellitus, Type 2 ; Glycated Hemoglobin ; Netherlands ; Diet ; Caribbean People ; South American People
Chemical Substances	Glycated Hemoglobin
Language	English
Publishing date	2024-04-10
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2609314-5
ISSN	2044-4052 ; 2044-4052
ISSN (online)	2044-4052
ISSN	2044-4052
DOI	10.1038/s41387-024-00275-5
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Article ; Online: Validating human induced pluripotent stem cell-specific quality control tests for the release of an intermediate drug product in a Good Manufacturing Practice quality system.

Novoa, Juan / Westra, Inge / Steeneveld, Esther / Neves, Natascha Fonseca / Daleman, Lizanne / Asensio, Albert Blanch / Davis, Richard P / Carlotti, Françoise / Freund, Christian / Rabelink, Ton / Meij, Pauline / Wieles, Brigitte

Cytotherapy

2024

Abstract: One of the challenges in Good Manufacturing Practice (GMP)-compliant human induced pluripotent stem cell (hiPSC) production is the validation of quality control (QC) tests specific for hiPSCs, which are required for GMP batch release. This study presents ...

Abstract	One of the challenges in Good Manufacturing Practice (GMP)-compliant human induced pluripotent stem cell (hiPSC) production is the validation of quality control (QC) tests specific for hiPSCs, which are required for GMP batch release. This study presents a comprehensive description of the validation process for hiPSC-specific GMP-compliant QC assays; more specifically, the validation of assays to assess the potential presence of residual episomal vectors (REVs), the expression of markers of the undifferentiated state and the directed differentiation potential of hiPSCs. Critical aspects and specific acceptance criteria were formulated in a validation plan prior to assay validation. Assay specificity, sensitivity and reproducibility were tested, and the equipment used for each assay was subjected to performance qualification. A minimum input of 20 000 cells (120 ng of genomic DNA) was defined for accurate determination of the presence of REVs. Furthermore, since vector loss in hiPSC lines is a passage-dependent process, we advocate screening for REVs between passages eight and 10, as testing at earlier passages might lead to unnecessary rejection of hiPSC lines. The cutoff value for assessment of markers of the undifferentiated state was set to the expression of at least three individual markers on at least 75% of the cells. When multi-color flow cytometry panels are used, a fluorescence minus one control is advised to ensure the control for fluorescent spread. For the assay to assess the directed differentiation potential, the detection limit was set to two of three positive lineage-specific markers for each of the three individual germ layers. All of our assays proved to be reproducible and specific. Our data demonstrate that our implemented analytical procedures are suitable as QC assays for the batch release of GMP-compliant hiPSCs.
Language	English
Publishing date	2024-04-14
Publishing country	England
Document type	Journal Article
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2024.04.004
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Article ; Online: Preliminary Assessment of Safety and Tolerability of Avacopan During the Early Access Program for ANCA-Associated Vasculitis

van Leeuwen JR / Popov T / Obergfell A / Rabelink TJ / Teng YKO

Biologics: Targets & Therapy, Vol Volume 17, Pp 11-

2023 Volume 14

Abstract: Jolijn R van Leeuwen,1,* Tamara Popov,2,* Achim Obergfell,2 Ton J Rabelink,1 YK Onno Teng1 1Center ...

Abstract	Jolijn R van Leeuwen,1,* Tamara Popov,2,* Achim Obergfell,2 Ton J Rabelink,1 YK Onno Teng1 1Center of Expertise for Lupus-, Vasculitis- and Complement-Mediated Systemic Diseases (LuVaCs), Department of Internal Medicine - Nephrology Section, Leiden University Medical Center, Leiden, the Netherlands; 2Vifor Pharma Ltd, Glattbrugg, Switzerland*These authors contributed equally to this workCorrespondence: YK Onno Teng, Department of Nephrology, Leiden University Medical Center (LUMC), P.O. Box 9600, 2300 RC, Leiden, the Netherlands, Tel +31-071-5262148, Fax +31-071-5266868, Email Y.K.O.Teng@lumc.nl
Keywords	n/a ; Medicine (General) ; R5-920
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Dove Medical Press
Document type	Article ; Online
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Article ; Online: Therapeutic plasma exchange in pregnancy: A literature review.

Wind, M / Gaasbeek, A G A / Oosten, L E M / Rabelink, T J / van Lith, J M M / Sueters, M / Teng, Y K O

European journal of obstetrics, gynecology, and reproductive biology

2021 Volume 260, Page(s) 29–36

Abstract: Therapeutic plasma exchange (TPE) is indicated as a treatment for a wide array of diseases, extensively addressed in the Guidelines of the American Society for Apheresis. In pregnancy, TPE is an uncommon event and application is largely based on ... ...

Abstract	Therapeutic plasma exchange (TPE) is indicated as a treatment for a wide array of diseases, extensively addressed in the Guidelines of the American Society for Apheresis. In pregnancy, TPE is an uncommon event and application is largely based on extrapolation of efficacy and safety in a non-pregnant population. This review intends to describe the currently available experience of TPE in pregnancy to help clinicians recognise indications during pregnancy and to support current guideline recommendations with literature-based experiences. In order to identify the clinical indications for which TPE is applied in pregnant women, we performed a literature search including studies till November 2019, without a start date restriction. Data extraction included medical indication for TPE and safety of TPE in pregnant women. 279 studies were included for analysis. Nowadays, TPE is predominantly applied for thrombotic microangiopathies, lipid disorders and a variety of autoimmune diseases. The application of TPE during pregnancy remains largely empiric and relies on individual case reports in the absence of high-quality studies and definitive evidence-based guidelines. Safety profile of TPE during pregnancy appears to be comparable to application of TPE in non-pregnant patients. In conclusion, based on the limited evidence that we found in literature with a high risk of publication bias, TPE procedures can be used safely during pregnancy with the appropriate preparation and experience of a multidisciplinary team.
MeSH term(s)	Autoimmune Diseases/therapy ; Blood Component Removal ; Female ; Humans ; Plasma Exchange ; Pregnancy ; Retrospective Studies ; Thrombotic Microangiopathies
Language	English
Publishing date	2021-03-03
Publishing country	Ireland
Document type	Journal Article ; Review
ZDB-ID	190605-7
ISSN	1872-7654 ; 0301-2115 ; 0028-2243
ISSN (online)	1872-7654
ISSN	0301-2115 ; 0028-2243
DOI	10.1016/j.ejogrb.2021.02.027
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Article: Glycosaminoglycans and fucoidan have a protective effect on experimental glomerulonephritis.

Buijsers, Baranca / Maciej-Hulme, Marissa / Jacobs, Maaike / Bebber, Marinka Bakker-van / de Graaf, Mark / Salmenov, Rustem / Parr, Naomi / Rabelink, Ton J / Nijenhuis, Tom / van der Vlag, Johan

Frontiers in molecular biosciences

2023 Volume 10, Page(s) 1223972

Abstract: Background: ...

Abstract	Background:
Language	English
Publishing date	2023-07-05
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2814330-9
ISSN	2296-889X
ISSN	2296-889X
DOI	10.3389/fmolb.2023.1223972
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