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https://www.readbyqxmd.com/read/28535123/topical-otic-drugs-in-a-multi-purpose-manufacturing-facility-a-guide-on-determination-and-application-of-permitted-daily-exposure-pde
#1
Lisa Wiesner, Maarten Prause, Ester Lovsin Barle
Due to newly introduced EU GMP guideline for Medicinal Products for Human and Veterinary use (PIC/S, 2015), product specific PDE for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. EMA (2014) guidance on setting PDE limits so far focused on systemic administration routes such as IV, oral or inhalation. This manuscript wants to give guidance on setting PDE values for risk management purposes in multi-purpose facilities for Active Pharmaceutical Ingredients (APIs) applied as topical otic drugs to the outer ear canal...
May 23, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28534831/rapidly-simultaneous-determination-of-six-effective-components-in-cistanche-tubulosa-by-near-infrared-spectroscopy
#2
Xinhong Wang, Xiaoguang Wang, Yuhai Guo
Quantitative determination of multiple effective components in a given plant usually requires a very large amount of authentic natural products. In this study, we proposed a rapid and non-destructive method for the simultaneous determination of echinacoside, verbascoside, mannitol, sucrose, glucose and fructose in Cistanche tubulosa by near infrared spectroscopy (NIRS). Near infrared diffuse reflectance spectroscopy (DRS) and high performance liquid chromatography (HPLC) were conducted on 116 batches of C. tubulosa samples...
May 19, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28534085/atp-induced-ca-2-signalling-mechanisms-in-the-regulation-of-mesenchymal-stem-cell-migration
#3
REVIEW
Lin-Hua Jiang, Fatema Mousawi, Xuebin Yang, Sėbastien Roger
The ability of cells to migrate to the destined tissues or lesions is crucial for physiological processes from tissue morphogenesis, homeostasis and immune responses, and also for stem cell-based regenerative medicines. Cytosolic Ca(2+) is a primary second messenger in the control and regulation of a wide range of cell functions including cell migration. Extracellular ATP, together with the cognate receptors on the cell surface, ligand-gated ion channel P2X receptors and a subset of G-protein-coupled P2Y receptors, represents common autocrine and/or paracrine Ca(2+) signalling mechanisms...
May 22, 2017: Cellular and Molecular Life Sciences: CMLS
https://www.readbyqxmd.com/read/28534038/analysis-of-mitochondrial-transfer-in-direct-co-cultures-of-human-monocyte-derived-macrophages-mdm-and-mesenchymal-stem-cells-msc
#4
Megan V Jackson, Anna D Krasnodembskaya
Mesenchymal stem/stromal cells (MSC) are adult stem cells which have been shown to improve survival, enhance bacterial clearance and alleviate inflammation in pre-clinical models of acute respiratory distress syndrome (ARDS) and sepsis. These diseases are characterised by uncontrolled inflammation often underpinned by bacterial infection. The mechanisms of MSC immunomodulatory effects are not fully understood yet. We sought to investigate MSC cell contact-dependent communication with alveolar macrophages (AM), professional phagocytes which play an important role in the lung inflammatory responses and anti-bacterial defence...
May 5, 2017: Bio-protocol
https://www.readbyqxmd.com/read/28532900/combinatorial-screening-of-3d-biomaterial-properties-that-promote-myofibrogenesis-for-mesenchymal-stromal-cell-based-heart-valve-tissue-engineering
#5
Jenna Usprech, David A Romero, Cristina H Amon, Craig A Simmons
The physical and chemical properties of a biomaterial integrate with soluble cues in the cell microenvironment to direct cell fate and function. Predictable biomaterial-based control of integrated cell responses has been investigated with two-dimensional (2D) screening platforms, but integrated responses in 3D have largely not been explored systematically. To address this need, we developed a screening platform using polyethylene glycol norbornene (PEG-NB) as a model biomaterial with which the polymer wt% (to control elastic modulus) and adhesion peptide types (RGD, DGEA, YIGSR) and densities could be controlled independently and combinatorially in arrays of 3D hydrogels...
May 19, 2017: Acta Biomaterialia
https://www.readbyqxmd.com/read/28532058/interaction-of-nanostructured-tio2-biointerfaces-with-stem-cells-and-biofilm-forming-bacteria
#6
Mukta Kulkarni, Ita Junkar, Petr Humpolíček, Zdenka Capáková, Katarzyna Anna Radaszkiewicz, Nikola Mikušová, Jiří Pacherník, Marián Lehocký, Aleš Iglič, Markéta Hanáčková, Miran Mozetič
Nanostructured TiO2 nanotubes (NTs) of diameters from 15 to 100nm were fabricated by an electrochemical anodization process. Biofilm-positive strains of Bacillus cereus and Pseudomonas aeruginosa behaved similarly on all TiO2 NTs as well as on native titanium (Ti) foil. The adhesion and growth of mesenchymal stem cells (MSc), embryonic stem cells (ESc), and pure cardiomyocytes derived from ESc exhibited significant differences. MSc as well as ESc were, in contrast to cardiomyocytes, able to adhere, and grow on TiO2 NTs...
August 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
https://www.readbyqxmd.com/read/28529067/immunoproapoptotic-molecule-scfv-fdt-tbid-modified-mesenchymal-stem-cells-for-prostate-cancer-dual-targeted-therapy
#7
Fengqi Yan, Xia Li, Nan Li, Rui Zhang, Qinhao Wang, Yi Ru, Xiaoke Hao, Jianxin Ni, He Wang, Guojun Wu
Highly efficient target therapy is urgently needed for prostate cancer with overexpression of γ-seminoprotein (γ-SM). Recent studies indicated that mesenchymal stem cells (MSCs) are attractive candidate for cell-based, targeted therapy due to their tumor tropism. Here we designed a dual-target therapeutic system in which MSCs were engineered to produce and deliver scFv-Fdt-tBid, a novel γ-SM-targeted immunoproapoptotic molecule. Such engineered MSCs (MSC.scFv-Fdt-tBid) would home to tumor sites and release the fusion protein to induce the apoptosis of prostate cancer cells...
May 18, 2017: Cancer Letters
https://www.readbyqxmd.com/read/28529022/effect-of-microgravity-on-the-mesenchymal-stem-cell-characteristics-of-limbal-fibroblasts
#8
Shu-I Pao, Ke-Hung Chien, Hsin-Ting Lin, Ming-Cheng Tai, Jiann-Torng Chen, Chang-Min Liang
BACKGROUND: Mesenchymal stem cells (MSCs) are important for regenerative medicine. Limbal fibroblasts (LFs), present in the corneal limbus, have been shown to possess MSC characteristics, and can differentiate into other cell types. The current study sought to investigate the effect of microgravity on the proliferation and differentiation of LFs, and identify culture conditions to obtain a high proportion of LFs possessing MSC characteristics. METHODS: A rotary cell culture system was used to generate microgravity...
May 18, 2017: Journal of the Chinese Medical Association: JCMA
https://www.readbyqxmd.com/read/28528702/detailed-characterization-of-mesenchymal-stem-stromal-cells-from-a-large-cohort-of-aml-patients-demonstrates-a-definitive-link-to-treatment-outcomes
#9
Rafael Diaz de la Guardia, Belen Lopez-Millan, Jessie R Lavoie, Clara Bueno, Julio Castaño, Maite Gómez-Casares, Susana Vives, Laura Palomo, Manel Juan, Julio Delgado, Maria L Blanco, Josep Nomdedeu, Alberto Chaparro, Jose Luis Fuster, Eduardo Anguita, Michael Rosu-Myles, Pablo Menéndez
Bone marrow mesenchymal stem/stromal cells (BM-MSCs) are key components of the hematopoietic niche thought to have a direct role in leukemia pathogenesis. BM-MSCs from patients with acute myeloid leukemia (AML) have been poorly characterized due to disease heterogeneity. We report a functional, genetic, and immunological characterization of BM-MSC cultures from 46 AML patients, stratified by molecular/cytogenetics into low-risk (LR), intermediate-risk (IR), and high-risk (HR) subgroups. Stable MSC cultures were successfully established and characterized from 40 of 46 AML patients irrespective of the risk subgroup...
May 18, 2017: Stem Cell Reports
https://www.readbyqxmd.com/read/28526296/mesenchymal-stem-cells-mscs-attenuate-cutaneous-sclerodermatous-graft-versus-host-disease-scl-gvhd-through-inhibition-of-immune-cell-infiltration-in-a-mouse-model
#10
Ji-Young Lim, Da-Bin Ryu, Sung-Eun Lee, Gyeongsin Park, Chang-Ki Min
Human chronic graft-versus-host disease (CGVHD) shares clinical characteristics with a murine sclerodermatous GVHD (Scl-GVHD) model that is characterized by skin thickening and lung fibrosis. A B10.D2 → BALB/c transplant model of Scl-GVHD was used to address the therapeutic effect of mesenchymal stem cells (MSCs) on the development of CGVHD. The clinical and pathological severity of cutaneous Scl-GVHD was significantly attenuated in MSC-treated recipients relative to Scl-GVHD controls. After MSC treatment, skin collagen production was significantly reduced with consistent downregulation of TGF-β expression...
May 16, 2017: Journal of Investigative Dermatology
https://www.readbyqxmd.com/read/28526089/adipose-derived-mesenchymal-stem-cells-from-liposuction-and-resected-fat-are-feasible-sources-for-regenerative-medicine
#11
Sandra Schneider, Marina Unger, Martijn van Griensven, Elizabeth R Balmayor
BACKGROUND: The use of mesenchymal stem cells (MSCs) in research and in regenerative medicine has progressed. Bone marrow as a source has drawbacks because of subsequent morbidities. An easily accessible and valuable source is adipose tissue. This type of tissue contains a high number of MSCs, and obtaining higher quantities of tissue is more feasible. Fat tissue can be harvested using different methods such as liposuction and resection. First, a detailed isolation protocol with complete characterization is described...
May 19, 2017: European Journal of Medical Research
https://www.readbyqxmd.com/read/28524859/mesenchymal-stem-cells-sense-mitochondria-released-from-damaged-cells-as-danger-signals-to-activate-their-rescue-properties
#12
Meriem Mahrouf-Yorgov, Lionel Augeul, Claire Crola Da Silva, Maud Jourdan, Muriel Rigolet, Sylvie Manin, René Ferrera, Michel Ovize, Adeline Henry, Aurélie Guguin, Jean-Paul Meningaud, Jean-Luc Dubois-Randé, Roberto Motterlini, Roberta Foresti, Anne-Marie Rodriguez
Mesenchymal stem cells (MSCs) protect tissues against cell death induced by ischemia/reperfusion insults. This therapeutic effect seems to be controlled by physiological cues released by the local microenvironment following injury. Recent lines of evidence indicate that MSC can communicate with their microenvironment through bidirectional exchanges of mitochondria. In particular, in vitro and in vivo studies report that MSCs rescue injured cells through delivery of their own mitochondria. However, the role of mitochondria conveyed from somatic cells to MSC remains unknown...
May 19, 2017: Cell Death and Differentiation
https://www.readbyqxmd.com/read/28524762/exosomes-promote-restoration-after-an-experimental-animal-model-of-intracerebral-hemorrhage
#13
Laura Otero-Ortega, Mari Carmen Gómez de Frutos, Fernando Laso-García, Berta Rodríguez-Frutos, Esperanza Medina-Gutiérrez, Juan Antonio López, Jesús Vázquez, Exuperio Díez-Tejedor, María Gutiérrez-Fernández
Exosomes are gaining importance because they show great promise in therapeutic applications for several diseases. Particularly in stroke, exosomes derived from mesenchymal stem cell (MSC) therapy work as paracrine effectors responsible for promoting neurovascular remodeling and functional recovery. Adult male rats were subjected to intracerebral hemorrhage (ICH) by intrastriatal injection of collagenase type IV; 24 h after surgery, MSC-derived exosomes were administered through the tail vein. The rats were euthanized at 7 or 28 days after treatment...
January 1, 2017: Journal of Cerebral Blood Flow and Metabolism
https://www.readbyqxmd.com/read/28523512/reduced-adipogenesis-after-lung-tumor-exosomes-priming-in-human-mesenchymal-stem-cells-via-tgf%C3%AE-signaling-pathway
#14
Shihua Wang, Xiaoxia Li, Meiqian Xu, Jing Wang, Robert Chunhua Zhao
A key feature of cancer cachexia is the loss of adipose tissue, mainly due to increased lipolysis and an impairment of adipogenesis. Recent findings have shown that cancer exosomes promoted lipolysis in adipose tissue. However, effects of cancer exosomes on adipogenesis were not reported. In this study, we found that lung cancer exosomes could be internalized by human adipose tissue-derived mesenchymal stem cells (hAD-MSCs) and significantly inhibited hAD-MSC adipogenesis as demonstrated by Oil Red O staining and decreased expression of adipogenic-specific genes...
May 18, 2017: Molecular and Cellular Biochemistry
https://www.readbyqxmd.com/read/28521479/association-between-non-melanoma-and-melanoma-skin-cancer-rates-vitamin-d-and-latitude
#15
Miguel Rivas, Elisa Rojas, Gloria M Calaf, Marcela Barberán, Claudio Liberman, Marcelo De Paula Correa
Vitamin D synthesis takes place in the skin due to solar ultraviolet-B (UVB) radiation. Several studies have shown the association between low sun exposure, non-melanoma skin cancer (NMSC) and a lack of vitamin D synthesis. Since such synthesis in the body depends on the exposure of the skin to solar UVB radiation (290-320 nm), experimental measurements of this type of solar radiation are important. Tarapaca University in Arica, Chile, established a solar UV radiation laboratory in 2006 and since then this laboratory has performed systematic experimental solar UVB measurements using a calibrated biometer instrument...
May 2017: Oncology Letters
https://www.readbyqxmd.com/read/28521114/msc-ecm-cellular-complexes-induce-periodontal-tissue-regeneration
#16
M Takewaki, M Kajiya, K Takeda, S Sasaki, S Motoike, N Komatsu, S Matsuda, K Ouhara, N Mizuno, T Fujita, H Kurihara
Transplantation of mesenchymal stem cells (MSCs), which possess self-renewing properties and multipotency, into a periodontal defect is thought to be a useful option for periodontal tissue regeneration. However, developing more reliable and predictable implantation techniques is still needed. Recently, we generated clumps of an MSC/extracellular matrix (ECM) complex (C-MSC), which consisted of cells and self-produced ECM. C-MSCs can regulate their cellular functions in vitro and can be grafted into a defect site, without any artificial scaffold, to induce bone regeneration...
May 1, 2017: Journal of Dental Research
https://www.readbyqxmd.com/read/28520516/mesenchymal-stem-cell-migration-and-proliferation-are-mediated-by-hypoxia-inducible-factor-1%C3%AE-upstream-of-notch-and-sumo-pathways
#17
María Ciria, Nahuel A García, Imelda Ontoria-Oviedo, Hernán González-King, Rubén Carrero, José Luis De La Pompa, José Anastasio Montero, Pilar Sepúlveda
Mesenchymal stem cells (MSCs) are effective in treating several pathologies. We and others have demonstrated that hypoxia or hypoxia-inducible factor 1 alpha (HIF-1α) stabilization improves several MSC functions, including cell adhesion, migration, and proliferation, thereby increasing their therapeutic potential. To further explore the mechanisms induced by HIF-1α in MSCs, we studied its relationship with Notch signaling and observed that overexpression of HIF-1α in MSCs increased protein levels of the Notch ligands Jagged 1-2 and Delta-like (Dll)1, Dll3, and Dll4 and potentiated Notch signaling only when this pathway was activated...
May 18, 2017: Stem Cells and Development
https://www.readbyqxmd.com/read/28520232/human-ipsc-msc-derived-xenografts-modulate-immune-responses-by-inhibiting-the-cleavage-of-caspases
#18
Cheng-Lin Li, Yun Leng, Bin Zhao, Chang Gao, Fei-Fei Du, Ning Jin, Qi-Zhou Lian, Shuang-Yue Xu, Guo-Liang Yan, Jun-Jie Xia, Guo-Hong Zhuang, Qing-Ling Fu, Zhong-Quan Qi
Mesenchymal stem cells (MSCs) negatively modulate immune properties. Induced pluripotent stem cells (iPSCs)-derived MSCs are alternative source of MSCs. However, the effects of iPSC-MSCs on T cells phenotypes in vivo remain unclear. We established an iPSC-MSC-transplanted host versus graft reaction mouse model using subcapsular kidney injection. Th1, Th2, regulatory T cells (Treg), and Th17 phenotypes and their cytokines were investigated in vivo and in vitro. The role of caspases and the soluble factors involved in the effects of MSCs were examined...
May 18, 2017: Stem Cells
https://www.readbyqxmd.com/read/28515792/mesenchymal-stem-cell-therapy-in-type-2-diabetes-mellitus
#19
REVIEW
Li Zang, Haojie Hao, Jiejie Liu, Yijun Li, Weidong Han, Yiming Mu
Type 2 diabetes mellitus (T2DM), which is characterized by the combination of relative insulin deficiency and insulin resistance, cannot be reversed with existing therapeutic strategies. Transplantation of insulin-producing cells (IPCs) was once thought to be the most promising strategy for treating diabetes, but the pace from the laboratory to clinical application has been obstructed due to its drawbacks. Mesenchymal stem cells (MSCs) harbor differentiation potential, immunosuppressive properties, and anti-inflammatory effects, and they are considered an ideal candidate cell type for treatment of DM...
2017: Diabetology & Metabolic Syndrome
https://www.readbyqxmd.com/read/28515335/in-situ-bone-tissue-engineering-via-ultrasound-mediated-gene-delivery-to-endogenous-progenitor-cells-in-mini-pigs
#20
Maxim Bez, Dmitriy Sheyn, Wafa Tawackoli, Pablo Avalos, Galina Shapiro, Joseph C Giaconi, Xiaoyu Da, Shiran Ben David, Jayne Gavrity, Hani A Awad, Hyun W Bae, Eric J Ley, Thomas J Kremen, Zulma Gazit, Katherine W Ferrara, Gadi Pelled, Dan Gazit
More than 2 million bone-grafting procedures are performed each year using autografts or allografts. However, both options carry disadvantages, and there remains a clear medical need for the development of new therapies for massive bone loss and fracture nonunions. We hypothesized that localized ultrasound-mediated, microbubble-enhanced therapeutic gene delivery to endogenous stem cells would induce efficient bone regeneration and fracture repair. To test this hypothesis, we surgically created a critical-sized bone fracture in the tibiae of Yucatán mini-pigs, a clinically relevant large animal model...
May 17, 2017: Science Translational Medicine
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