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https://www.readbyqxmd.com/read/29678523/safety-and-efficacy-of-mesenchymal-stem-cells-for-radiation-induced-xerostomia-a-randomized-placebo-controlled-phase-1-2-trial-mesrix
#1
Christian Grønhøj, David H Jensen, Peter Vester-Glowinski, Siri Beier Jensen, Allan Bardow, Roberto S Oliveri, Lea Munthe Fog, Lena Specht, Carsten Thomsen, Sune Darkner, Michael Jensen, Vera Müller, Katalin Kiss, Tina Agander, Elo Andersen, Anne Fischer-Nielsen, Christian von Buchwald
BACKGROUND: Salivary gland hypofunction and xerostomia are major complications to head and neck radiotherapy. This trial assessed the safety and efficacy of adipose tissue-derived mesenchymal stem cell (ASC) therapy for radiation-induced xerostomia. PATIENT AND METHODS: This randomized, placebo-controlled phase 1/2 trial included 30 patients, randomized in a 1:1 ratio to receive ultrasound-guided transplantation of ASCs or placebo to the submandibular glands. Patients had previously received radiotherapy for a T1-2, N0-2A, human papillomavirus-positive, oropharyngeal squamous cell carcinoma...
March 6, 2018: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/29655662/evaluation-of-low-intensity-anti-coagulation-with-a-fully-magnetically-levitated-centrifugal-flow-circulatory-pump-the-magentum-1-study
#2
Ivan Netuka, Peter Ivák, Zuzana Tučanová, Stanislav Gregor, Ondrej Szárszoi, Poornima Sood, Daniel Crandall, Jessica Rimsans, Jean Marie Connors, Mandeep R Mehra
BACKGROUND: The HeartMate 3 left ventricular assist system is engineered to avoid pump thrombosis, yet bleeding complications persist. We investigated the safety of low-intensity anti-coagulation in patients with the HeartMate 3. METHODS: The Minimal AnticoaGulation EvaluatioNTo aUgment heMocompatibility (MAGENTUM 1) pilot study is a prospective, single-arm study of low-intensity warfarin anti-coagulation in patients implanted with the HeartMate 3 pump. After standard warfarin anti-coagulation (international normalized ratio [INR] 2...
March 27, 2018: Journal of Heart and Lung Transplantation
https://www.readbyqxmd.com/read/29650408/normothermic-ex-vivo-preservation-with-the-portable-organ-care-system-lung-device-for-bilateral-lung-transplantation-inspire-a-randomised-open-label-non-inferiority-phase-3-study
#3
Gregor Warnecke, Dirk Van Raemdonck, Michael A Smith, Gilbert Massard, Jasleen Kukreja, Federico Rea, Gabriel Loor, Fabio De Robertis, Jayan Nagendran, Kumud K Dhital, Francisco Javier Moradiellos Díez, Christoph Knosalla, Christian A Bermudez, Steven Tsui, Kenneth McCurry, I-Wen Wang, Tobias Deuse, Guy Lesèche, Pascal Thomas, Igor Tudorache, Christian Kühn, Murat Avsar, Bettina Wiegmann, Wiebke Sommer, Arne Neyrinck, Marco Schiavon, Fiorella Calebrese, Nichola Santelmo, Anne Olland, Pierre-Emanuel Falcoz, Andre R Simon, Andres Varela, Joren C Madsen, Marshall Hertz, Axel Haverich, Abbas Ardehali
BACKGROUND: Severe primary graft dysfunction (PGD) of grade 3 (PGD3) is a common serious complication following lung transplantation. We aimed to assess physiological donor lung preservation using the Organ Care System (OCS) Lung device compared with cold static storage. METHODS: In this non-inferiority, randomised, controlled, open-label, phase 3 trial (INSPIRE) recipients were aged 18 years or older and were registered as standard criteria primary double lung transplant candidates...
April 9, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29630119/intramuscular-islet-allotransplantation-in-type-1-diabetes-mellitus
#4
F Bertuzzi, G Colussi, A Lauterio, L De Carlis
OBJECTIVE: Alternative sites to the liver for islet transplantation have been studied for a long time. Intramuscular islet transplantation appears to be an alternative site to the liver because of the ease of access. First islet autotransplantations were reported in patients after total pancreatectomies. The transplanted islets showed a proper revascularization and their function was observed for up to 2 years after the implant. However, only a few cases of autotransplantation and no allotransplantation have been performed...
March 2018: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/29627677/preparation-of-high-bioactivity-multilayered-bone-marrow-mesenchymal-stem-cell-sheet-for-myocardial-infarction-using-a-3d-dynamic-system
#5
Yingwei Wang, Jianhua Zhang, Zixi Qin, Zepei Fan, Cheng Lu, Baoxin Chen, Jupeng Zhao, Xiaojuan Li, Fei Xiao, Xi Lin, Zheng Wu
Cell sheet techniques offer a promising future for myocardial infarction (MI) therapy; however, insufficient nutrition supply remains the major limitation in maintaining stem cell bioactivities in vitro. In order to enhance cell sheet mechanical strength and bioactivities, a decellularized porcine pericardium (DPP) scaffold was prepared by the phospholipase A2 method, and aspartic acid was used as a spacer arm to improve the vascular endothelial growth factor crosslink efficiency on the DPP scaffold. Based on this scaffold, multilayered bone marrow mesenchymal stem cell sheets were rapidly constructed, using RAD16-I peptide hydrogel as a temporary 3D scaffold, and cell sheets were cultured in either the 3D-dynamic system (DCcs) or the traditional static condition (SCcs)...
April 5, 2018: Acta Biomaterialia
https://www.readbyqxmd.com/read/29624575/montelukast-for-bronchiolitis-obliterans-syndrome-after-lung-transplantation-a-randomized-controlled-trial
#6
David Ruttens, Stijn E Verleden, Heleen Demeyer, Dirk E Van Raemdonck, Jonas Yserbyt, Lieven J Dupont, Bart M Vanaudenaerde, Robin Vos, Geert M Verleden
Bronchiolitis obliterans syndrome (BOS) remains the major problem which precludes long-term survival after lung transplantation. Previously, an open label pilot study from our group demonstrated a possible beneficial effect of montelukast in progressive BOS patients with low airway neutrophilia (<15%), and already on azithromycin treatment, in whom the further decline in pulmonary function was attenuated. This was, however, a non-randomized and non-placebo controlled trial. The study design is a single center, prospective, interventional, randomized, double blind, placebo-controlled trial, with a two arm parallel group design and an allocation ratio of 1:1...
2018: PloS One
https://www.readbyqxmd.com/read/29609890/increasing-circulating-sphingosine-1-phosphate-attenuates-lung-injury-during-ex-vivo-lung-perfusion
#7
J Hunter Mehaffey, Eric J Charles, Adishesh K Narahari, Sarah Schubert, Victor E Laubach, Nicholas R Teman, Kevin R Lynch, Irving L Kron, Ashish K Sharma
BACKGROUND: Sphingosine-1-phosphate regulates endothelial barrier integrity and promotes cell survival and proliferation. We hypothesized that upregulation of sphingosine-1-phosphate during ex vivo lung perfusion would attenuate acute lung injury and improve graft function. METHODS: C57BL/6 mice (n = 4-8/group) were euthanized, followed by 1 hour of warm ischemia and 1 hour of cold preservation in a model of donation after cardiac death. Subsequently, mice underwent 1 hour of ex vivo lung perfusion with 1 of 4 different perfusion solutions: Steen solution (Steen, control arm), Steen with added sphingosine-1-phosphate (Steen + sphingosine-1-phosphate), Steen plus a selective sphingosine kinase 2 inhibitor (Steen + sphingosine kinase inhibitor), or Steen plus both additives (Steen + sphingosine-1-phosphate + sphingosine kinase inhibitor)...
March 11, 2018: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/29602631/a-randomized-trial-of-a-multicomponent-intervention-to-promote-medication-adherence-the-teen-adherence-in-kidney-transplant-effectiveness-of-intervention-trial-take-it
#8
Bethany J Foster, Ahna L H Pai, Nataliya Zelikovsky, Sandra Amaral, Lorraine Bell, Vikas R Dharnidharka, Diane Hebert, Crystal Holly, Baerbel Knauper, Douglas Matsell, Veronique Phan, Rachel Rogers, Jodi M Smith, Huaqing Zhao, Susan L Furth
BACKGROUND: Poor adherence to immunosuppressive medications is a major cause of premature graft loss among children and young adults. Multicomponent interventions have shown promise but have not been fully evaluated. STUDY DESIGN: Unblinded parallel-arm randomized trial to assess the efficacy of a clinic-based adherence-promoting intervention. SETTING & PARTICIPANTS: Prevalent kidney transplant recipients 11 to 24 years of age and 3 or more months posttransplantation at 8 kidney transplantation centers in Canada and the United States (February 2012 to May 2016) were included...
March 15, 2018: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/29595085/immunosuppressive-and-antiviral-treatment-of-hepatitis-c-virus-associated-glomerular-disease-a-long-term-follow-up
#9
Fabrizio Fabrizi, Alessio Aghemo, Pietro Lampertico, Mirella Fraquelli, Donata Cresseri, Gabriella Moroni, Patrizia Passerini, Francesca M Donato, Piergiorgio Messa
BACKGROUND: The evidence in the medical literature on the treatment of hepatitis C virus-associated glomerular disease is extremely limited. The advent of nonconventional immunosuppressive agents and direct-acting antivirals promises high efficacy and safety. AIMS: We conducted an open-label, single-arm clinical study to examine the efficacy and safety of a combined approach for hepatitis C virus-associated glomerular disease. METHODS: In the first phase of the study, patients with hepatitis C virus-associated glomerular disease received interferon-based antiviral therapy and immunosuppressive agents; since 2013, interferon-free antiviral therapy was adopted and novel immunosuppressants (including B-cell depleting agents and mycophenolate mofetil) or immunomodulators (ribavirin) were choiced...
March 1, 2018: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/29584546/nivolumab-for-relapsed-refractory-classic-hodgkin-lymphoma-after-failure-of-autologous-hematopoietic-cell-transplantation-extended-follow-up-of-the-multicohort-single-arm-phase-ii-checkmate-205-trial
#10
Philippe Armand, Andreas Engert, Anas Younes, Michelle Fanale, Armando Santoro, Pier Luigi Zinzani, John M Timmerman, Graham P Collins, Radhakrishnan Ramchandren, Jonathon B Cohen, Jan Paul De Boer, John Kuruvilla, Kerry J Savage, Marek Trneny, Margaret A Shipp, Kazunobu Kato, Anne Sumbul, Benedetto Farsaci, Stephen M Ansell
Purpose Genetic alterations causing overexpression of programmed death-1 ligands are near universal in classic Hodgkin lymphoma (cHL). Nivolumab, a programmed death-1 checkpoint inhibitor, demonstrated efficacy in relapsed/refractory cHL after autologous hematopoietic cell transplantation (auto-HCT) in initial analyses of one of three cohorts from the CheckMate 205 study of nivolumab for cHL. Here, we assess safety and efficacy after extended follow-up of all three cohorts. Methods This multicenter, single-arm, phase II study enrolled patients with relapsed/refractory cHL after auto-HCT treatment failure into cohorts by treatment history: brentuximab vedotin (BV)-naïve (cohort A), BV received after auto-HCT (cohort B), and BV received before and/or after auto-HCT (cohort C)...
March 27, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29570164/the-benefits-of-hypothermic-machine-preservation-and-short-cold-ischemia-times-in-deceased-donor-kidneys
#11
Jjhfm Kox, C Moers, D Monbaliu, A Strelniece, J Treckmann, I Jochmans, Hgd Leuvenink, Lwe Van Heurn, J Pirenne, A Paul, R J Ploeg
BACKGROUND: Hypothermic machine perfusion (HMP) of deceased donor kidneys is associated with better outcome when compared to static cold storage (CS). Nevertheless, there is little evidence whether kidneys with short cold ischemia time (CIT) also benefit from HMP and whether HMP can safely extend CIT. METHODS: We analysed prospectively collected data from the Machine Preservation Trial, an international randomized controlled trial. 752 Consecutive renal transplants were included: 1 kidney of each of the 376 donors was preserved by HMP, the contralateral organ was preserved by CS...
March 22, 2018: Transplantation
https://www.readbyqxmd.com/read/29565157/-influence-of-liver-transplantation-in-the-nutritional-profile-of-severe-cirrhotic-patients
#12
Caroline Pinho R Andrade, Mileda L T Portugal, Ellén De Sousa Paz, Paula A Freitas, Ana Filomena C S Daltro, Kaluce G S Almondes, Carla Soraya C Maia, Ariclecio Cunha de Oliveira
OBJECTIVE: The aim of this study was to analyze the influence of liver transplantation in food intake and nutritional status of severe cirrhotic patients. METHODS: The sample consisted of 23 patients who underwent liver transplantation. Three 24-hour dietary recall were applied and anthropometric measurements were collected before and three months after transplantation. The consumption of macronutrients and fat soluble vitamins were also evaluated. The anthropometric data evaluated were body mass index, abdominal circumference, percentage of adequacy of arm circumference, triceps skinfold thickness and arm muscle circumference...
January 16, 2018: Nutrición Hospitalaria: Organo Oficial de la Sociedad Española de Nutrición Parenteral y Enteral
https://www.readbyqxmd.com/read/29555246/functional-outcomes-18-months-after-total-and-midarm-transplantation-a-case-report
#13
M Iglesias, M Ramírez-Berumen, P Butrón, J Alberú-Gómez, F Salazar-Hernández, J Macias-Gallardo, R P Leal-Villalpando, J Zamudio-Bautista, V Acosta, L Jauregui, A Hernández-Campos, V Espinosa-Cruz, J Vázquez-Lamadrid, J González-Sánchez, J Cuellar-Rodriguez, J G Sierra-Madero, R Gaytan-Cervantes, S Contreras-Barbosa, A Navarro-Lara, J Guzman-Gonzalez, J Domínguez-Cherit, M Vilatoba, S Toussaint-Caire, F Vega-Boada, F J Gómez-Pérez, M Mayorquin-Ruiz
BACKGROUND: The function reported after arm transplantation is deemed beneficial relative to the marked disability that upper arm amputation causes. OBJECTIVE: We report a 51-year-old man with a Disabilities of the Arm, Shoulder and Hand (DASH) score of 75.83 who underwent bilateral arm transplantation in October 2015. PROCEDURE: The right arm was transplanted at the glenohumeral joint level, including transplantation of the humeral head, joint capsule, and rotator cuff ligaments and tendons...
March 16, 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29541460/optimization-of-an-in-house-pcr-method-for-the-detection-of-hla-b-27-alleles
#14
Noor Afshan, Mukarram Bashir, Hamid Nawaz Tipu, Mohammad Hussain
The association of spondyloarthropathies with different alleles of human leukocyte antigen (HLA) B*27 is well established. Different subtypes of HLA-B*27 may be linked with different ethnic groups, distinct clinical manifestations, specific age of onset and different prognoses. Polymerase chain reaction with sequence specific primers (PCR-SSP) is the most frequently adapted molecular method used for the recognition of HLA-B*27-specific DNA sequences. The aim of the present study was to standarise an in-house protocol of PCR-SSP for HLA-B*27 allele detection for use in the Armed Forces Institute of Pathology (AFIP), Pakistan, with consideration of its cost effectiveness...
April 2018: Biomedical Reports
https://www.readbyqxmd.com/read/29528181/disease-burden-and-conditioning-regimens-in-asct1221-a-randomized-phase-ii-trial-in-children-with-juvenile-myelomonocytic-leukemia-a-children-s-oncology-group-study
#15
Christopher C Dvorak, Prakash Satwani, Elliot Stieglitz, Mitchell S Cairo, Ha Dang, Qinglin Pei, Yun Gao, Donna Wall, Tali Mazor, Adam B Olshen, Joel S Parker, Samir Kahwash, Betsy Hirsch, Susana Raimondi, Neil Patel, Micah Skeens, Todd Cooper, Parinda A Mehta, Stephan A Grupp, Mignon L Loh
BACKGROUND: Most patients with juvenile myelomonocytic leukemia (JMML) are curable only with allogeneic hematopoietic cell transplantation (HCT). However, the current standard conditioning regimen, busulfan-cyclophosphamide-melphalan (Bu-Cy-Mel), may be associated with higher risks of morbidity and mortality. ASCT1221 was designed to test whether the potentially less-toxic myeloablative conditioning regimen containing busulfan-fludarabine (Bu-Flu) would be associated with equivalent outcomes...
March 12, 2018: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/29527263/homologous-recombination-mediates-stable-fah-gene-integration-and-phenotypic-correction-in-tyrosinaemia-mouse-model
#16
Norman Junge, Qinggong Yuan, Thu Huong Vu, Simon Krooss, Christien Bednarski, Asha Balakrishnan, Toni Cathomen, Michael P Manns, Ulrich Baumann, Amar Deep Sharma, Michael Ott
AIM: To stably correct tyrosinaemia in proliferating livers of fumarylacetoacetate-hydrolase knockout ( Fah -/-) mice by homologous-recombination-mediated targeted addition of the Fah gene. METHODS: C57BL/6 Fah∆exon5 mice served as an animal model for human tyrosinaemia type 1 in our study. The vector was created by amplifying human Fah cDNA including the TTR promoter from a lentivirus plasmid as described. The Fah expression cassette was flanked by homologous arms (620 bp and 749 bp long) of the Rosa26 gene locus...
February 27, 2018: World Journal of Hepatology
https://www.readbyqxmd.com/read/29526920/-current-status-of-development-for-regenerative-cell-therapy-sb623
#17
Takehiko Kaneko
SanBio Co., Ltd. is developing regenerative medicine, SB623. SB623 secretes neurotrophic and growth factors, and can possibly show benefit in repair of the damaged brain after stroke. An open-label, single-arm phase I/IIa clinical study was conducted with 18 chronic ischemic stroke patients in the United States to evaluate the safety and clinical outcomes of surgical transplantation of SB623. Clinical evaluation for a one year follow-up period showed significant improvements with all mean scores on the European Stroke Scale, the National Institute of Health Stroke Scale, and on the basis of fugl-Meyer Assessment...
2018: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
https://www.readbyqxmd.com/read/29519780/robotic-versus-open-renal-transplantation-in-obese-patients-protocol-for-a-cost-benefit-markov-model-analysis
#18
Michele Molinari, Chethan Puttarajappa, Martin Wijkstrom, Armando Ganoza, Roberto Lopez, Amit Tevar
BACKGROUND: Recent studies have reported a significant decrease in wound problems and hospital stay in obese patients undergoing renal transplantation by robotic-assisted minimally invasive techniques with no difference in graft function. OBJECTIVE: Due to the lack of cost-benefit studies on the use of robotic-assisted renal transplantation versus open surgical procedure, the primary aim of our study is to develop a Markov model to analyze the cost-benefit of robotic surgery versus open traditional surgery in obese patients in need of a renal transplant...
March 8, 2018: JMIR Research Protocols
https://www.readbyqxmd.com/read/29518094/a-randomized-controlled-trial-based-algorithm-for-insulin-pump-therapy-in-hyperglycemic-patients-early-after-kidney-transplantation
#19
Johannes M Werzowa, Marcus D Säemann, Alexander Mohl, Michael Bergmann, Christopher C Kaltenecker, Wolfgang Brozek, Andreas Thomas, Michael Haidinger, Marlies Antlanger, Johannes J Kovarik, Chantal Kopecky, Peter X K Song, Klemens Budde, Julio Pascual, Manfred Hecking
Treating hyperglycemia in previously non-diabetic individuals with exogenous insulin immediately after kidney transplantation reduced the odds of developing Posttransplantation Diabetes Mellitus (PTDM) in our previous proof-of-concept clinical trial. We hypothesized that insulin-pump therapy with maximal insulin dosage during the afternoon would improve glycemic control compared to basal insulin and standard-of-care. In a multi-center, randomized, controlled trial testing insulin isophane for PTDM prevention, we added a third study arm applying continuous subcutaneous insulin lispro infusion (CSII) treatment...
2018: PloS One
https://www.readbyqxmd.com/read/29513901/do-arteriovenous-fistulas-increase-cardiac-risk
#20
Randall Faull, Nitesh Rao, Matthew Worthley
An effectively functioning arteriovenous fistula is the life line for patients on long-term hemodialysis, and for most an upper limb, native vessel fistula has significant short- and long-term advantages. There are, however, situations where a fistula has deleterious effects, including the relatively uncommon problem of severe heart failure exacerbated in particular by high-flow fistulas. There is also increasing evidence that a fistula can add to the already high burden of cardiovascular risk in patients with advanced kidney disease, including by promoting water and salt retention, and by inducing or worsening left ventricular hypertrophy...
March 7, 2018: Seminars in Dialysis
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