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Article: The ascendance of microphysiological systems to solve the drug testing dilemma.

Dehne, Eva-Maria / Hasenberg, Tobias / Marx, Uwe

Future science OA

2017 Volume 3, Issue 2, Page(s) FSO185

Abstract: The development of drugs is a process obstructed with manifold security and efficacy concerns. Although animal models are still widely used to meet the diligence required, they are regarded as outdated tools with limited predictability. Novel ... ...

Abstract	The development of drugs is a process obstructed with manifold security and efficacy concerns. Although animal models are still widely used to meet the diligence required, they are regarded as outdated tools with limited predictability. Novel microphysiological systems intend to create systemic models of human biology. Their ability to host 3D organoid constructs in a controlled microenvironment with mechanical and electrophysiological stimuli enables them to create and maintain homeostasis. These platforms are, thus, envisioned to be superior tools for testing and developing substances such as drugs, cosmetics and chemicals. We will present reasons why microphysiological systems are required for the emerging demands, highlight current technological and regulatory obstacles, and depict possible solutions from state-of-the-art platforms from major contributors.
Language	English
Publishing date	2017-03-31
Publishing country	England
Document type	Journal Article ; Review
ISSN	2056-5623
ISSN	2056-5623
DOI	10.4155/fsoa-2017-0002
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility.

Stem cell reports

2024 Volume 19, Issue 5, Page(s) 604–617

Abstract: Cell culture technology has evolved, moving from single-cell and monolayer methods to 3D models like reaggregates, spheroids, and organoids, improved with bioengineering like microfabrication and bioprinting. These advancements, termed microphysiological ...

Abstract	Cell culture technology has evolved, moving from single-cell and monolayer methods to 3D models like reaggregates, spheroids, and organoids, improved with bioengineering like microfabrication and bioprinting. These advancements, termed microphysiological systems (MPSs), closely replicate tissue environments and human physiology, enhancing research and biomedical uses. However, MPS complexity introduces standardization challenges, impacting reproducibility and trust. We offer guidelines for quality management and control criteria specific to MPSs, facilitating reliable outcomes without stifling innovation. Our fit-for-purpose recommendations provide actionable advice for achieving consistent MPS performance.
MeSH term(s)	Humans ; Reproducibility of Results ; Cell Culture Techniques/methods ; Quality Control ; Organoids/cytology ; Microphysiological Systems
Language	English
Publishing date	2024-04-25
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2720528-9
ISSN	2213-6711 ; 2213-6711
ISSN (online)	2213-6711
ISSN	2213-6711
DOI	10.1016/j.stemcr.2024.03.009
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Article ; Online: Organ-on-a-chip: Determine feasibility of a human liver microphysiological model to assess long-term steroid metabolites in sports drug testing.

Görgens, Christian / Ramme, Anja Patricia / Guddat, Sven / Schrader, Yvonne / Winter, Annika / Dehne, Eva-Maria / Horland, Reyk / Thevis, Mario

Drug testing and analysis

2021 Volume 13, Issue 11-12, Page(s) 1921–1928

Abstract: A fundamental challenge in preventive doping research is the study of metabolic pathways of substances banned in sport. However, the pharmacological predictions obtained by conventional in vitro or in vivo animal studies are occasionally of limited ... ...

Abstract	A fundamental challenge in preventive doping research is the study of metabolic pathways of substances banned in sport. However, the pharmacological predictions obtained by conventional in vitro or in vivo animal studies are occasionally of limited transferability to humans according to an inability of in vitro models to mimic higher order system physiology or due to various species-specific differences using animal models. A more recently established technology for simulating human physiology is the "organ-on-a-chip" principle. In a multichannel microfluidic cell culture chip, 3-dimensional tissue spheroids, which can constitute artificial and interconnected microscale organs, imitate principles of the human physiology. The objective of this study was to determine if the technology is suitable to adequately predict metabolic profiles of prohibited substances in sport. As model compounds, the frequently misused anabolic steroids, stanozolol and dehydrochloromethyltestosterone (DHCMT) were subjected to human liver spheroids in microfluidic cell culture chips. The metabolite patterns produced and circulating in the chip media were then assessed by LC-HRMS/(MS) at different time points of up to 14 days of incubation at 37°C. The overall profile of observed glucurono-conjugated stanozolol metabolites excellently matched the commonly found urinary pattern of metabolites, including 3'OH-stanozolol-glucuronide and stanozolol-N-glucuronides. Similarly, but to a lower extent, the DHCMT metabolic profile was in agreement with phase-I and phase-II biotransformation products regularly seen in postadministration urine specimens. In conclusion, this pilot study indicates that the "organ-on-a-chip" technology provides a high degree of conformity with traditional human oral administration studies, providing a promising approach for metabolic profiling in sports drug testing.
MeSH term(s)	Chromatography, Liquid/methods ; Doping in Sports/prevention & control ; Feasibility Studies ; Humans ; Lab-On-A-Chip Devices ; Liver/metabolism ; Pilot Projects ; Spheroids, Cellular/metabolism ; Stanozolol/analysis ; Stanozolol/metabolism ; Substance Abuse Detection/methods ; Tandem Mass Spectrometry/methods ; Testosterone/analogs & derivatives ; Testosterone/analysis ; Testosterone/metabolism
Chemical Substances	D-4-chloro-17 beta-hydroxy-3-oxo-17 alpha-methylandrosta-1,4-diene (2446-23-3) ; Testosterone (3XMK78S47O) ; Stanozolol (4R1VB9P8V3)
Language	English
Publishing date	2021-09-22
Publishing country	England
Document type	Journal Article
ZDB-ID	2462336-2
ISSN	1942-7611 ; 1942-7603
ISSN (online)	1942-7611
ISSN	1942-7603
DOI	10.1002/dta.3161
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Article ; Online: A Human Stem Cell-Derived Brain-Liver Chip for Assessing Blood-Brain-Barrier Permeation of Pharmaceutical Drugs.

Koenig, Leopold / Ramme, Anja Patricia / Faust, Daniel / Mayer, Manuela / Flötke, Tobias / Gerhartl, Anna / Brachner, Andreas / Neuhaus, Winfried / Appelt-Menzel, Antje / Metzger, Marco / Marx, Uwe / Dehne, Eva-Maria

Cells

2022 Volume 11, Issue 20

Abstract: Significant advancements in the field of preclinical in vitro blood-brain barrier (BBB) models have been achieved in recent years, by developing monolayer-based culture systems towards complex multi-cellular assays. The coupling of those models with ... ...

Abstract	Significant advancements in the field of preclinical in vitro blood-brain barrier (BBB) models have been achieved in recent years, by developing monolayer-based culture systems towards complex multi-cellular assays. The coupling of those models with other relevant organoid systems to integrate the investigation of blood-brain barrier permeation in the larger picture of drug distribution and metabolization is still missing. Here, we report for the first time the combination of a human induced pluripotent stem cell (hiPSC)-derived blood-brain barrier model with a cortical brain and a liver spheroid model from the same donor in a closed microfluidic system (MPS). The two model compounds atenolol and propranolol were used to measure permeation at the blood-brain barrier and to assess metabolization. Both substances showed an in vivo-like permeation behavior and were metabolized in vitro. Therefore, the novel multi-organ system enabled not only the measurement of parent compound concentrations but also of metabolite distribution at the blood-brain barrier.
MeSH term(s)	Humans ; Atenolol/metabolism ; Blood-Brain Barrier/metabolism ; Brain ; Induced Pluripotent Stem Cells/metabolism ; Liver ; Pharmaceutical Preparations/metabolism ; Propranolol/metabolism
Chemical Substances	Atenolol (50VV3VW0TI) ; Pharmaceutical Preparations ; Propranolol (9Y8NXQ24VQ)
Language	English
Publishing date	2022-10-19
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2661518-6
ISSN	2073-4409 ; 2073-4409
ISSN (online)	2073-4409
ISSN	2073-4409
DOI	10.3390/cells11203295
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Article: An Individual Patient's "Body" on Chips-How Organismoid Theory Can Translate Into Your Personal Precision Therapy Approach.

Marx, Uwe / Accastelli, Enrico / David, Rhiannon / Erfurth, Hendrik / Koenig, Leopold / Lauster, Roland / Ramme, Anja Patricia / Reinke, Petra / Volk, Hans-Dieter / Winter, Annika / Dehne, Eva-Maria

Frontiers in medicine

2021 Volume 8, Page(s) 728866

Abstract: The first concepts for reproducing human systemic organismal ... ...

Abstract	The first concepts for reproducing human systemic organismal biology
Language	English
Publishing date	2021-09-13
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2021.728866
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Article ; Online: An Individual Patient's “Body” on Chips—How Organismoid Theory Can Translate Into Your Personal Precision Therapy Approach

Uwe Marx / Enrico Accastelli / Rhiannon David / Hendrik Erfurth / Leopold Koenig / Roland Lauster / Anja Patricia Ramme / Petra Reinke / Hans-Dieter Volk / Annika Winter / Eva-Maria Dehne

Frontiers in Medicine, Vol

2021 Volume 8

Abstract: The first concepts for reproducing human systemic organismal biology in vitro were developed over 12 years ago. Such concepts, then called human- or body-on-a-chip, claimed that microphysiological systems would become the relevant technology platform ... ...

Abstract	The first concepts for reproducing human systemic organismal biology in vitro were developed over 12 years ago. Such concepts, then called human- or body-on-a-chip, claimed that microphysiological systems would become the relevant technology platform emulating the physiology and morphology of human organisms at the smallest biologically acceptable scale in vitro and, therefore, would enable the selection of personalized therapies for any patient at unprecedented precision. Meanwhile, the first human organoids—stem cell-derived complex three-dimensional organ models that expand and self-organize in vitro—have proven that in vitro self-assembly of minute premature human organ-like structures is feasible, once the respective stimuli of ontogenesis are provided to human stem cells. Such premature organoids can precisely reflect a number of distinct physiological and pathophysiological features of their respective counterparts in the human body. We now develop the human-on-a-chip concepts of the past into an organismoid theory. We describe the current concept and principles to create a series of organismoids—minute, mindless and emotion-free physiological in vitro equivalents of an individual's mature human body—by an artificially short process of morphogenetic self-assembly mimicking an individual's ontogenesis from egg cell to sexually mature organism. Subsequently, we provide the concept and principles to maintain such an individual's set of organismoids at a self-sustained functional healthy homeostasis over very long time frames in vitro. Principles how to perturb a subset of healthy organismoids by means of the natural or artificial induction of diseases are enrolled to emulate an individual's disease process. Finally, we discuss using such series of healthy and perturbed organismoids in predictively selecting, scheduling and dosing an individual patient's personalized therapy or medicine precisely. The potential impact of the organismoid theory on our healthcare system generally and the rapid adoption of ...
Keywords	organismoid ; organ-on-chip ; microphysiological systems ; real world data ; immune-oncology ; advanced therapies ; Medicine (General) ; R5-920
Subject code	170
Language	English
Publishing date	2021-09-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A Human Stem Cell-Derived Brain-Liver Chip for Assessing Blood-Brain-Barrier Permeation of Pharmaceutical Drugs

2022

Abstract	Significant advancements in the field of preclinical in vitro blood-brain barrier (BBB) models have been achieved in recent years, by developing monolayer-based culture systems towards complex multi-cellular assays. The coupling of those models with other relevant organoid systems to integrate the investigation of blood-brain barrier permeation in the larger picture of drug distribution and metabolization is still missing. Here, we report for the first time the combination of a human induced pluripotent stem cell (hiPSC)-derived blood-brain barrier model with a cortical brain and a liver spheroid model from the same donor in a closed microfluidic system (MPS). The two model compounds atenolol and propranolol were used to measure permeation at the blood–brain barrier and to assess metabolization. Both substances showed an in vivo-like permeation behavior and were metabolized in vitro. Therefore, the novel multi-organ system enabled not only the measurement of parent compound concentrations but also of metabolite distribution at the blood-brain barrier. 11 20
Keywords	blood-brain barrier (BBB) model ; brain–liver chip ; human induced pluripotent stem cells (hiPSCs) ; microphysiological systems (MPS) ; multi-organ chip ; DDC::600 Technik ; Medizin ; angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit ; angewandte Wissenschaften::610 Medizin und Gesundheit::614 Inzidenz und Präventation von Krankheiten
Subject code	610
Language	English
Publishing country	de
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Human multi-organ chip co-culture of bronchial lung culture and liver spheroids for substance exposure studies

Katharina Schimek / Stefan Frentzel / Karsta Luettich / David Bovard / Isabel Rütschle / Laura Boden / Felix Rambo / Hendrik Erfurth / Eva-Maria Dehne / Annika Winter / Uwe Marx / Julia Hoeng

Scientific Reports, Vol 10, Iss 1, Pp 1-

2020 Volume 13

Abstract: Abstract Extrapolation of cell culture-based test results to in vivo effects is limited, as cell cultures fail to emulate organ complexity and multi-tissue crosstalk. Biology-inspired microphysiological systems provide preclinical insights into ... ...

Abstract	Abstract Extrapolation of cell culture-based test results to in vivo effects is limited, as cell cultures fail to emulate organ complexity and multi-tissue crosstalk. Biology-inspired microphysiological systems provide preclinical insights into absorption, distribution, metabolism, excretion, and toxicity of substances in vitro by using human three-dimensional organotypic cultures. We co-cultured a human lung equivalent from the commercially available bronchial MucilAir culture and human liver spheroids from HepaRG cells to assess the potential toxicity of inhaled substances under conditions that permit organ crosstalk. We designed a new HUMIMIC Chip with optimized medium supply and oxygenation of the organ cultures and cultivated them on-chip for 14 days in separate culture compartments of a closed circulatory perfusion system, demonstrating the viability and homeostasis of the tissue cultures. A single-dose treatment of the hepatotoxic and carcinogenic aflatoxin B1 impaired functionality in bronchial MucilAir tissues in monoculture but showed a protective effect when the tissues were co-cultured with liver spheroids, indicating that crosstalk can be achieved in this new human lung–liver co-culture. The setup described here may be used to determine the effects of exposure to inhaled substances on a systemic level.
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2020-05-01T00:00:00Z
Publisher	Nature Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Validation of Bioreactor and Human-on-a-Chip Devices for Chemical Safety Assessment.

Rebelo, Sofia P / Dehne, Eva-Maria / Brito, Catarina / Horland, Reyk / Alves, Paula M / Marx, Uwe

Advances in experimental medicine and biology

2016 Volume 856, Page(s) 299–316

Abstract: Equipment and device qualification and test assay validation in the field of tissue engineered human organs for substance assessment remain formidable tasks with only a few successful examples so far. The hurdles seem to increase with the growing ... ...

Abstract	Equipment and device qualification and test assay validation in the field of tissue engineered human organs for substance assessment remain formidable tasks with only a few successful examples so far. The hurdles seem to increase with the growing complexity of the biological systems, emulated by the respective models. Controlled single tissue or organ culture in bioreactors improves the organ-specific functions and maintains their phenotypic stability for longer periods of time. The reproducibility attained with bioreactor operations is, per se, an advantage for the validation of safety assessment. Regulatory agencies have gradually altered the validation concept from exhaustive "product" to rigorous and detailed process characterization, valuing reproducibility as a standard for validation. "Human-on-a-chip" technologies applying micro-physiological systems to the in vitro combination of miniaturized human organ equivalents into functional human micro-organisms are nowadays thought to be the most elaborate solution created to date. They target the replacement of the current most complex models-laboratory animals. Therefore, we provide here a road map towards the validation of such "human-on-a-chip" models and qualification of their respective bioreactor and microchip equipment along a path currently used for the respective animal models.
MeSH term(s)	Bioreactors ; Chemical Safety ; Humans ; Lab-On-A-Chip Devices ; Validation Studies as Topic
Language	English
Publishing date	2016
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ISSN	2214-8019 ; 0065-2598
ISSN (online)	2214-8019
ISSN	0065-2598
DOI	10.1007/978-3-319-33826-2_12
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Article ; Online: Human multi-organ chip co-culture of bronchial lung culture and liver spheroids for substance exposure studies.

Schimek, Katharina / Frentzel, Stefan / Luettich, Karsta / Bovard, David / Rütschle, Isabel / Boden, Laura / Rambo, Felix / Erfurth, Hendrik / Dehne, Eva-Maria / Winter, Annika / Marx, Uwe / Hoeng, Julia

Scientific reports

2020 Volume 10, Issue 1, Page(s) 7865

Abstract: Extrapolation of cell culture-based test results to in vivo effects is limited, as cell cultures fail to emulate organ complexity and multi-tissue crosstalk. Biology-inspired microphysiological systems provide preclinical insights into absorption, ... ...

Abstract	Extrapolation of cell culture-based test results to in vivo effects is limited, as cell cultures fail to emulate organ complexity and multi-tissue crosstalk. Biology-inspired microphysiological systems provide preclinical insights into absorption, distribution, metabolism, excretion, and toxicity of substances in vitro by using human three-dimensional organotypic cultures. We co-cultured a human lung equivalent from the commercially available bronchial MucilAir culture and human liver spheroids from HepaRG cells to assess the potential toxicity of inhaled substances under conditions that permit organ crosstalk. We designed a new HUMIMIC Chip with optimized medium supply and oxygenation of the organ cultures and cultivated them on-chip for 14 days in separate culture compartments of a closed circulatory perfusion system, demonstrating the viability and homeostasis of the tissue cultures. A single-dose treatment of the hepatotoxic and carcinogenic aflatoxin B
MeSH term(s)	Administration, Inhalation ; Aflatoxin B1/pharmacology ; Apoptosis/drug effects ; Bronchi/cytology ; Bronchi/drug effects ; Bronchi/metabolism ; Cell Survival/drug effects ; Cells, Cultured ; Coculture Techniques/methods ; Hepatocytes/cytology ; Hepatocytes/drug effects ; Hepatocytes/metabolism ; Humans ; Liver/cytology ; Liver/drug effects ; Liver/metabolism ; Lung/cytology ; Lung/drug effects ; Lung/metabolism ; Organ Culture Techniques/methods ; Poisons/pharmacology ; Protective Agents/pharmacology ; Spheroids, Cellular/cytology ; Spheroids, Cellular/drug effects ; Spheroids, Cellular/metabolism
Chemical Substances	Poisons ; Protective Agents ; Aflatoxin B1 (9N2N2Y55MH)
Language	English
Publishing date	2020-05-12
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-020-64219-6
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