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U Altanerova, K Benejova, V Altanerova, S Tyciakova, B Rychly, P Szomolanyi, F Ciampor, M Cihova, V Repiska, K Ondicova, B Mravec, C Altaner
We report on a simple iron oxide (Venofer) labeling procedure of dental pulp mesenchymal stem cells (DP-MSCs) and DP-MSCs transduced with yeast cytosinedeaminase::uracilphosphoribosyltransferase (yCD::UPRT-DP-MSCs). Venofer is a drug approved for intravenous application to treat iron deficiency anemia in patients. Venofer labeling did not affect DP-MSCs or yCD::UPRT-DP-MSCs viability and growth kinetics. Electron microscopy of labeled cells showed internalized Venofer nanoparticles in endosomes. MRI relativity measurement of Venofer labeled DP-MSCs in a phantom arrangement revealed that 100 cells per 0...
2016: Neoplasma
Yu S Milovanov, N A Mukhin, L V Kozlovskaya, S Yu Milovanova, M M Markina
AIM: To investigate the impact of anemia correction with erythropoiesis stimulants on the serum level of the circulating morphogenetic protein α-Klotho in patients with Stages 3B--4 chronic kidney disease (CKD). SUBJECTS AND METHODS: 64 patients aged 42±8 years with Stages 3B--4 nondiabetic CKD were examined and divided into 2 groups: 1) 32 patients with anemia (the target hemoglobin levels could be achieved and kept with erythropoietin and iron saccharate in 20 patients (Group A) and those could not be done in 12 patients (Group 1B)...
2016: Terapevticheskiĭ Arkhiv
Mohammad Reza Abassi, Amin Safavi, Masoumeh Haghverdi, Babak Saedi
Kidney failure affects different aspects of normal life. Among different manifestations, sleep problem can be considered as a common complaint of ESRD (End Stage Renal Disease) patients. In this study, we aimed to investigate the interrelationship between sleep disorders in ESRD patients and their characteristics. Through a cross-sectional study (2010-2011), 88 ESRD patients undergoing maintenance hemodialysis thrice weekly were recruited to enter the study. We used a self-administered questionnaire into which the data were reflected...
March 2016: Acta Medica Iranica
Martha L Louzada, Cyrus C Hsia, Fatimah Al-Ani, Fiona Ralley, Anargyros Xenocostas, Janet Martin, Sarah E Connelly, Ian H Chin-Yee, Leonard Minuk, Alejandro Lazo-Langner
BACKGROUND: Intravenous iron therapy is a treatment option for iron deficient patients who are intolerant to oral iron or where oral iron is ineffective, but with possible adverse effects. Currently, prospective studies comparing different intravenous iron formulations are needed to determine safety and efficacy of these agents. METHODS: We conducted a prospective, double-blind, randomized controlled trial (RCT) to assess the feasibility of a trial comparing the safety of high molecular weight intravenous iron dextran, Infufer®, with intravenous iron sucrose, Venofer®, in non-hemodialysis adult outpatients...
2016: BMC Hematology
Nikolaos Papadimitriou, Susann Li, Helena Barreto Henriksson
For evaluation of cell therapy applications, it is of interest to be able to trace and observe cellular distribution of the transplanted cells. The aim with the study was to examine viability, traceability, and multilineage capability of iron sucrose-labeled mesenchymal stem cells (MSCs) after transplantation into lapine intervertebral discs (IVDs). MSCs were collected from three human donors, age 31-50 years, and IVDs from 12 rabbits, age 3 months. MSCs were isolated from the bone marrow and cultured using standard protocols...
October 15, 2015: Stem Cells and Development
Sunil Bhandari, Philip A Kalra, Jatin Kothari, Patrice M Ambühl, Jeppe H Christensen, Ashot M Essaian, Lars L Thomsen, Iain C Macdougall, Daniel W Coyne
BACKGROUND: Iron deficiency anaemia is common in patients with chronic kidney disease, and intravenous iron is the preferred treatment for those on haemodialysis. The aim of this trial was to compare the efficacy and safety of iron isomaltoside 1000 (Monofer®) with iron sucrose (Venofer®) in haemodialysis patients. METHODS: This was an open-label, randomized, multicentre, non-inferiority trial conducted in 351 haemodialysis subjects randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sucrose (Group B)...
September 2015: Nephrology, Dialysis, Transplantation
Nikolaos Papadimitriou, Anna Thorfve, Camilla Brantsing, Katarina Junevik, Adad Baranto, Helena Barreto Henriksson
For evaluation of cell therapy strategies using human mesenchymal stem cells (hMSCs), it is important to be able to trace transplanted cells and their distribution in tissues, for example, cartilage, over time. The aim of the study was to determine effects on cell viability, traceability, and chondrogenic differentiation of hMSCs after iron labeling with iron sucrose. hMSCs were collected (seven donors, 13-57 years) from patients undergoing spinal surgery. Two subsets of experiments were performed. (1) Iron labeling of hMSCs: 1 mg/mL of Venofer(®) (iron sucrose) was added (16 h) to cultures...
November 1, 2014: Stem Cells and Development
Anila Thomas, Leif E Peterson
BACKGROUND: Ferric citrate is a novel phosphate binder which has the potential to reduce usage of erythropoietin-stimulating agents (ESAs) and intravenous (IV) iron used for anemia management during hemodialysis (HD) among patients with end-stage renal disease (ESRD). Currently, the potential health care cost savings on a national scale due to the use of ferric citrate in ESRD are undetermined. METHODS: Per-patient-per-year costs of ESAs (Epogen(®) and Aranesp(®) [Amgen Inc...
2014: International Journal of Nephrology and Renovascular Disease
Iain C Macdougall, William E Strauss, Justin McLaughlin, Zhu Li, Frank Dellanna, Joachim Hertel
BACKGROUND AND OBJECTIVES: Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia. This study compared the efficacy and safety of two intravenous iron products (ferumoxytol [Feraheme injection] and iron sucrose [Venofer]) in patients with CKD and iron deficiency anemia. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this phase II, randomized, open-label, active-controlled, multicenter clinical trial, patients were randomized 1:1 to either 1...
April 2014: Clinical Journal of the American Society of Nephrology: CJASN
Monika Praschberger, Carolin Cornelius, Markus Schitegg, Hans Goldenberg, Barbara Scheiber-Mojdehkar, Brigitte Sturm
CONTEXT: Severe iron deficiency requires intravenous iron supplementation to replenish iron stores. Intravenous iron sucrose has been used for decades for the treatment of anemia. New generic iron sucrose products are now marketed for the use in several countries and there is an ongoing discussion about the safety and efficacy of iron sucrose similars. OBJECTIVE: In this study, we compared the iron sucrose originator Venofer® and the generic iron sucrose AZAD (ISA) regarding bioavailability, toxicity and stability in human THP-1 cells and HepG2 cells...
March 2015: Pharmaceutical Development and Technology
S Fütterer, I Andrusenko, U Kolb, W Hofmeister, P Langguth
Drug products containing iron oxide and hydroxide nanoparticles (INPs) are important for the treatment of iron deficiency anaemia. Pharmaceuticals prepared by the complexation of different kinds of INPs and carbohydrates have different physicochemical and biopharmaceutic characteristics. The increasing number of parenteral non-biological complex drugs (NBCD) containing iron requires physicochemical methods for characterization and enabling of cross comparisons. In this context the structure and the level of crystallinity of the iron phases may be connected to the in vitro and in vivo dissolution rates, which etiologically determine the therapeutic and toxic effects...
December 2013: Journal of Pharmaceutical and Biomedical Analysis
Bhavesh S Barot, Punit B Parejiya, Dharmik M Mehta, Pragna K Shelat, Gaurang B Shah
Intravenous polynuclear iron formulations are vital components in the treatment of iron deficiency anemia associated with chronic kidney disease as well as other diseases associated with gastro-intestinal and cardio-vascular system. Intravenous iron preparations consist of iron-carbohydrate nanoparticles with iron-oxyhydroxide as a core covered by carbohydrate shell. These preparations should be very well characterized in terms of their physicochemical properties and pharmacological profile in order to establish safety and efficacy...
August 2014: Pharmaceutical Development and Technology
Peter Elford, Johanne Bouchard, Léonore Jaillet, Nick Pearson, Alexandra Rogue, Caroline Sabadie, Roy Forster
INTRODUCTION: We have examined iron biodistribution and hepatic gene expression in rats following administration of the generic Iron Sucrose Azad (ISA) or the reference iron sucrose drug Venofer®. METHODS: ISA and Venofer® were administered intravenously to normal, non-anemic, male rats at 15 mg/kg (a supra-therapeutic dose-level). To evaluate biodistribution, tissue iron levels were determined over 28 days for plasma, liver, spleen, bone marrow, heart, kidney, lung and stomach using a validated ICP-MS method...
November 2013: Journal of Pharmacological and Toxicological Methods
Reza Karimi Shervedani, Zakyeh Akrami
Deferrioxamine, a bacterial hydroxamic siderophore having high binding affinity for Fe(III), is used in its immobilized form, as self-assembled monolayer on Au, for accumulation and recognition of Fe(III) from the solution phase. The accumulated Fe(III) is detected via both active mode based on faradaic reduction current of Fe(III), and inactive mode based on impedimetric effect of accumulated Fe(III) against redox reaction of a suitable probe. Appropriate electrochemical techniques, square wave voltammetry and electrochemical impedance spectroscopy, are used for the transduction of analytical signals obtained by this sensor...
January 15, 2013: Biosensors & Bioelectronics
Vassilis Fragoulakis, Georgia Kourlaba, Dimitris Goumenos, Manousos Konstantoulakis, Nikolaos Maniadakis
PURPOSE: To conduct an economic evaluation comparing Ferinject(®) (ferric carboxymaltose [FCM]) with Venofer(®) (iron sucrose [IS]) and CosmoFer(®) (low-molecular-weight iron dextran [LMWID]) in the management of iron deficiency anemia in Greece. PATIENTS AND METHODS: A cost-minimization analysis was conducted since there are no clear data indicating that one of these regimens is superior to the others in terms of efficacy. Main data inputs were based on bibliography and validated by clinicians...
2012: ClinicoEconomics and Outcomes Research: CEOR
Markus R Jahn, Hans B Andreasen, Sören Fütterer, Thomas Nawroth, Volker Schünemann, Ute Kolb, Wolfgang Hofmeister, Manuel Muñoz, Klaus Bock, Morten Meldal, Peter Langguth
The treatment of iron deficiency anemia with polynuclear iron formulations is an established therapy in patients with chronic kidney disease but also in other disease areas like gastroenterology, cardiology, oncology, pre/post operatively and obstetrics' and gynecology. Parenteral iron formulations represent colloidal systems in the lower nanometer size range which have traditionally been shown to consist of an iron core surrounded by a carbohydrate shell. In this publication, we for the first time describe the novel matrix structure of iron isomaltoside 1000 which differs from the traditional picture of an iron core surrounded by a carbohydrate...
August 2011: European Journal of Pharmaceutics and Biopharmaceutics
Palle Bager, Jens F Dahlerup
BACKGROUND AND AIM: Anemia is common in IBD patients and intravenous iron treatment is preferred. The drug cost of intravenous iron carboxymaltose is approximately twice the cost of intravenous iron sucrose. The aim was to evaluate the health care costs of intravenous iron sucrose (Venofer®, Vifor) and intravenous iron carboxymaltose (Ferinject®, Vifor) treatment to IBD patients in an outpatient setting. METHODS: Based on data from 111 IBD patients treated with intravenous iron in an outpatient setting health care costs were evaluated by means of Budget Impact Analysis, Cost Effective Analysis and Cost Benefit Analysis...
October 2010: Journal of Crohn's & Colitis
Diane K Wysowski, Lynette Swartz, B Vicky Borders-Hemphill, Margie R Goulding, Catherine Dormitzer
Controversy exists about the safety of the parenteral iron dextran products, Dexferrum and INFeD, which have been associated with rare, serious anaphylactic-type reactions. In the United States, their product labels carry boxed warnings of this adverse event; some have called for the withdrawal from marketing of the higher molecular weight Dexferrum. Between 2002 and 2007, sales of Dexferrum, INFeD, and iron gluconate Ferrlecit declined 32.5%, 21%, and 4.8%, respectively, while sales of iron sucrose Venofer increased 160%...
September 2010: American Journal of Hematology
G Birgegård, K Schneider, J Ulfberg
BACKGROUND AND OBJECTIVES: Iron depletion is common in regular blood donors. The objective of the study was to investigate the frequency and severity of iron depletion in regular blood donors and whether IV iron is more effective than oral to avoid iron depletion and symptoms thereof, especially restless legs syndrome (RLS). METHOD: One hundred and twenty blood donors with at least five previous whole blood donations were randomized to receive either IV iron sucrose (Venofer(®), RenaPharma/Vifor, Uppsala, Sweden), 200 mg, or to 20×100 mg of oral iron sulphate (Duroferon(®), GlaxoSmithKline, Stockholm, Sweden), after each blood donation during 1 year...
November 2010: Vox Sanguinis
Lynda A Szczech, David B Bregman, Robert A Harrington, David Morris, Angelia Butcher, Todd A Koch, Lawrence T Goodnough, Myles Wolf, Jane E Onken
BACKGROUND: Patients with iron deficiency anaemia (IDA) in the setting of non-dialysis-dependent chronic kidney disease (NDD-CKD) may benefit from treatment with intravenous (IV) iron. Ferric carboxymaltose (FCM) is a novel IV iron formulation designed to permit larger infusions compared to currently available IV standards such as Venofer(R) (iron sucrose). METHODS: The primary objective of REPAIR-IDA is to estimate the cardiovascular safety and efficacy of FCM (two doses at 15 mg/kg to a maximum of 750 mg per dose) compared to Venofer(R) (1000 mg administered as five infusions of 200 mg) in subjects who have IDA and NDD-CKD...
July 2010: Nephrology, Dialysis, Transplantation
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