Showing papers by "Sai Kiang Lim published in 2015"
Paracelsus Private Medical University of Salzburg1, University of Duisburg-Essen2, Semmelweis University3, University of Turin4, Institut Gustave Roussy5, Brown University6, Pontifical Catholic University of Chile7, University of Barcelona8, Trinity College, Dublin9, Istituto Superiore di Sanità10, Ikerbasque11, Pohang University of Science and Technology12, University of Louisville13, Ghent University Hospital14, La Trobe University15, Harvard University16, National University of Singapore17, Maastricht University18, University of Mainz19, University of Cambridge20, Utrecht University21, Agency for Science, Technology and Research22, University of Gothenburg23, University of Valencia24, University of Freiburg25, Aalborg University26, National Research Council27, Paul Ehrlich Institute28, German Red Cross29, University of Oxford30, Karolinska Institutet31
TL;DR: In this paper, the authors summarize recent developments and the current knowledge of extracellular vesicles (EVs) and discuss safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application.
Abstract: Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed.
954 citations
TL;DR: It is proposed here that MSC exosomes function as an extension of MSC's biological role as tissue stromal support cells, enabling cells to recover critical cellular functions and begin repair and regeneration.
416 citations
TL;DR: An overview of the current use of EVs in CVD and a discussion of the need for robust and easy isolation technologies for plasma EV subsets are presented to bring this promising field towards clinical application in the patient are presented.
Abstract: Cardiovascular disease (CVD) is the leading cause of death worldwide and its prevalence is expected to rise rapidly worldwide in the coming decades. Atherosclerosis, the syndrome underlying CVD, is a chronic progressive disease of the arteries already present at a young age. Strokes, heart attacks and heart failure are acute CVD events that occur after decades, however, and require timely diagnosis and treatment. Plasma extracellular vesicles (EVs) are microstructures with a lipid bilayer membrane involved in hemostasis, inflammation and injury. Both EV-counts and EV-content are associated with CVD and the identification of plasma EVs is a novel source of blood-based biomarkers with the potential to improve diagnosis and prognosis of CVD. Presented in this review is an overview of the current use of EVs in CVD and a discussion of the need for robust and easy isolation technologies for plasma EV subsets. This is needed to bring this promising field towards clinical application in the patient.
46 citations
31 Dec 2015
TL;DR: In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program, summarize recent developments and the current knowledge of EV-based therapies.
Abstract: Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed.
22 citations
01 Jan 2015
TL;DR: Analysis of the proteomic and RNA cargo of the MSC exosome by high-throughput assays such as mass spectrometry, antibody arrays, and DNA probe arrays revealed an abundance of miRNAs and proteins that demonstrates that MSCExosome biogenesis is a highly regulated and therefore important process.
Abstract: Mesenchymal stem cells (MSCs) exert part of their therapeutic efficacy through exosomes present in their secretions. MSC exosomes are bilipid membrane vesicles that contain both proteins and RNAs. Analysis of the proteomic and RNA cargo of the MSC exosome by high-throughput assays such as mass spectrometry, antibody arrays, and DNA probe arrays revealed an abundance of miRNAs and proteins. The miRNAs and proteins in the exosomes represent a select fraction of miRNAs and proteins in MSCs. In addition, the exosomal miRNAs, unlike cellular miRNAs, are highly enriched in pre-miRNAs while the proteins are functionally clustered in several processes. Together, the selective composition of RNAs and proteins in MSC exosomes demonstrates that MSC exosome biogenesis is a highly regulated and therefore important process. Moreover, this selective RNA and protein composition could provide an insight into the molecular targets of MSC exosome-mediated therapy.
6 citations
Patent•
13 Mar 2015TL;DR: In this article, a microfluidic device may include: a plurality of valves connected to respective channels; a pluralityof chambers, including a mixing chamber, a sample collection chamber, and a waste collection chamber; a binding member configured to bind biomolecules.
Abstract: According to various embodiments, a microfluidic device may be provided. The microfluidic device may include: a plurality of valves connected to respective channels; a plurality of chambers, including a mixing chamber, a sample collection chamber, and a waste collection chamber; a binding member configured to bind biomolecules; and wherein flow of a liquid between the plurality of chambers is controlled by selectively opening and closing each valve of the plurality of valves to selectively allow air to be released from the channels connected to the respective valve.