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https://www.readbyqxmd.com/read/28544662/tracheal-replacement-therapy-with-a-stem-cell-seeded-graft-lessons-from-compassionate-use-application-of-a-gmp-compliant-tissue-engineered-medicine
#1
Martin J Elliott, Colin R Butler, Aikaterini Varanou-Jenkins, Leanne Partington, Carla Carvalho, Edward Samuel, Claire Crowley, Peggy Lange, Nicholas J Hamilton, Robert E Hynds, Tahera Ansari, Paul Sibbons, Anja Fierens, Claire McLaren, Derek Roebuck, Colin Wallis, Nagarajan Muthialu, Richard Hewitt, David Crabbe, Sam M Janes, Paolo De Coppi, Mark W Lowdell, Martin A Birchall
Tracheal replacement for the treatment of end-stage airway disease remains an elusive goal. The use of tissue-engineered tracheae in compassionate use cases suggests that such an approach is a viable option. Here, a stem cell-seeded, decellularized tissue-engineered tracheal graft was used on a compassionate basis for a girl with critical tracheal stenosis after conventional reconstructive techniques failed. The graft represents the first cell-seeded tracheal graft manufactured to full good manufacturing practice (GMP) standards...
June 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28535421/differentiation-of-crataegus-spp-guided-by-nuclear-magnetic-resonance-spectrometry-with-chemometric-analyses
#2
Jensen A Lund, Paula N Brown, Paul R Shipley
For compliance with US Current Good Manufacturing Practice regulations for dietary supplements, manufacturers must provide identity of source plant material. Despite the popularity of hawthorn as a dietary supplement, relatively little is known about the comparative phytochemistry of different hawthorn species, and in particular North American hawthorns. The combination of NMR spectrometry with chemometric analyses offers an innovative approach to differentiating hawthorn species and exploring the phytochemistry...
May 20, 2017: Phytochemistry
https://www.readbyqxmd.com/read/28533935/a-review-of-the-emerging-potential-therapy-for-neurological-disorders-human-embryonic-stem-cell-therapy
#3
REVIEW
Geeta Shroff, Jyoti Dhanda Titus, Rhea Shroff
The first human embryonic stem cell (hESC) line was developed in the late nineties. hESCs are capable of proliferating indefinitely and differentiate into all the three embryonic germ layers. Further, the differentiation of hESC lines into neural precursor cells and neurons, astrocytes and oligodendrocytes showed their potential in treating several incurable neurological disorders such as spinal cord injury (SCI), cerebral palsy (CP), Parkinson's disease (PD). In this review, we will discuss the global scenario of research and therapeutic use of hESCs in the treatment of neurological disorders...
2017: American Journal of Stem Cells
https://www.readbyqxmd.com/read/28532461/national-post-market-surveillance-assessment-of-veterinary-medicines-in-korea-during-the-past-decade
#4
JeongWoo Kang, Hae-Chul Park, Yang Ho Jang, Md Akil Hossain, Kyunghun Jeong, Mi Young Jeong, Seon-Jong Yun, Sung-Won Park, Dae Gyun Kim, Kwang-Jick Lee
BACKGROUND: Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine...
May 22, 2017: BMC Veterinary Research
https://www.readbyqxmd.com/read/28527516/a-feasible-economical-and-accurate-analytical-method-for-simultaneous-determination-of-six-alkaloid-markers-in-aconiti-lateralis-radix-praeparata-from-different-manufacturing-sources-and-processing-ways
#5
Yi-Bei Zhang, Juan DA, Jing-Xian Zhang, Shang-Rong Li, Xin Chen, Hua-Li Long, Qiu-Rong Wang, Lu-Ying Cai, Shuai Yao, Jin-Jun Hou, Wan-Ying Wu, De-An Guo
Aconiti Lateralis Radix Praeparata (Fuzi) is a commonly used traditional Chinese medicine in clinic for its potency in restoring yang and rescuing from collapse. Aconiti alkaloids, mainly including monoester-diterpenoidaconitines (MDAs) and diester-diterpenoidaconitines (DDAs), are considered to act as both bioactive and toxic constituents. In the present study, a feasible, economical, and accurate HPLC method for simultaneous determination of six alkaloid markers using the Single Standard for Determination of Multi-Components (SSDMC) method was developed and fully validated...
April 2017: Chinese Journal of Natural Medicines
https://www.readbyqxmd.com/read/28524929/xeno-free-cultivation-of-mesenchymal-stem-cells-from-the-corneal-stroma
#6
Steffi Matthyssen, Sorcha Ní Dhubhghaill, Veerle Van Gerwen, Nadia Zakaria
Purpose: The human cornea has recently been described as a source of corneal stroma-derived mesenchymal stem cells (hMSCs). In vitro expansion of these cells involves basal medium supplemented with fetal bovine serum (FBS). As animal-derived serum can confer a risk of disease transmission and can be subject to considerable lot-to-lot variability, it does not comply with newer Good Manufacturing Practice (GMP)-required animal component-free culture protocols for clinical translation. Methods: This study investigated animal-free alternatives to FBS for cultivation of human corneal stromal MSCs...
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28506532/accreditation-of-biosafe-clinical-grade-human-embryonic-stem-cells-according-to-chinese-regulations
#7
Qi Gu, Juan Wang, Lei Wang, Zheng-Xin Liu, Wan-Wan Zhu, Yuan-Qing Tan, Wei-Fang Han, Jun Wu, Chun-Jing Feng, Jin-Hui Fang, Lei Liu, Liu Wang, Wei Li, Xiao-Yang Zhao, Bao-Yang Hu, Jie Hao, Qi Zhou
Human embryonic stem cells (hESCs) are promising in regenerative medicine. Although several hESC-based clinical trials are under way, a widely accepted standard of clinical-grade cells remains obscure. To attain a completely xeno-free clinical-grade cell line, the system must be free of xenogenic components, the cells must have a comprehensive set of functions, and good manufacturing practice conditions must be used. In this study, following these criteria, we successfully derived two hESC lines, which were thereby considered "clinical-grade embryonic stem cells"...
May 11, 2017: Stem Cell Reports
https://www.readbyqxmd.com/read/28506275/global-survey-of-malaria-rapid-diagnostic-test-rdt-sales-procurement-and-lot-verification-practices-assessing-the-use-of-the-who-find-malaria-rdt-evaluation-programme-2011-2014
#8
Sandra Incardona, Elisa Serra-Casas, Nora Champouillon, Christian Nsanzabana, Jane Cunningham, Iveth J González
BACKGROUND: Malaria rapid diagnostic tests (RDTs) play a critical role in malaria case management, and assurance of quality is a key factor to promote good adherence to test results. Since 2007, the World Health Organization (WHO) and the Foundation for Innovative New Diagnostics (FIND) have coordinated a Malaria RDT Evaluation Programme, comprising a pre-purchase performance evaluation (product testing, PT) and a pre-distribution quality control of lots (lot testing, LT), the former being the basis of WHO recommendations for RDT procurement...
May 15, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28505028/cytomegalovirus-disease-in-hematopoietic-stem-cell-transplant-patients-current-and-future-therapeutic-options
#9
Shigeo Fuji, Hermann Einsele, Markus Kapp
PURPOSE OF REVIEW: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) has become one of the standard treatment for hematological diseases. Although the clinical outcome has improved significantly during the last decades, the morbidity and mortality after allo-HSCT are still obstacles to cure. Out of major morbidities, opportunistic virus infections such as cytomegalovirus (CMV) infection are important complications, in particular in patients who received human leukocyte antigen-mismatched HSCT...
May 12, 2017: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/28497074/efficient-production-of-papillomavirus-gene-delivery-vectors-in-defined-in%C3%A2-vitro-reactions
#10
Carla Cerqueira, Cynthia D Thompson, Patricia M Day, Yuk-Ying S Pang, Douglas R Lowy, John T Schiller
Papillomavirus capsids can package a wide variety of nonviral DNA plasmids and deliver the packaged genetic material to cells, making them attractive candidates for targeted gene delivery vehicles. However, the papillomavirus vectors generated by current methods are unlikely to be suitable for clinical applications. We have developed a chemically defined, cell-free, papillomavirus-based vector production system that allows the incorporation of purified plasmid DNA (pseudogenome) into high-titer papillomavirus L1/L2 capsids...
June 16, 2017: Molecular Therapy. Methods & Clinical Development
https://www.readbyqxmd.com/read/28488960/towards-pathogen-inactivation-of-red-blood-cells-and-whole-blood-targeting-viral-dna-rna-design-technologies-and-future-prospects-for-developing-countries
#11
REVIEW
Victor J Drew, Lassina Barro, Jerard Seghatchian, Thierry Burnouf
Over 110 million units of blood are collected yearly. The need for blood products is greater in developing countries, but so is the risk of contracting a transfusion-transmitted infection. Without efficient donor screening/viral testing and validated pathogen inactivation technology, the risk of transfusion-transmitted infections correlates with the infection rate of the donor population. The World Health Organization has published guidelines on good manufacturing practices in an effort to ensure a strong global standard of transfusion and blood product safety...
April 13, 2017: Blood Transfusion, Trasfusione del Sangue
https://www.readbyqxmd.com/read/28488944/a-scalable-and-accurate-method-for-quantifying-vector-genomes-of-recombinant-adeno-associated-viruses-in-crude-lysate
#12
Jianzhong Ai, Raed Ibraheim, Phillip W L Tai, Guangping Gao
Increasing interest and application of recombinant adeno-associated viruses (rAAVs) in basic and clinical research have urged efforts to improve rAAV production quality and yield. Standard vector production workflows call for genome titration of purified vectors at the endpoint of production to assess yield. Unfortunately, quality control measures for preparations during mid-production steps and economical means to assess the fidelity of multiple batches of rAAV preparations are lacking. Here we describe a scalable and accurate method for the direct quantitative polymerase chain reaction (qPCR) titration of rAAV genomes in crude lysate...
April 13, 2017: Human Gene Therapy Methods
https://www.readbyqxmd.com/read/28479180/accelerated-and-long-term-stability-study-of-pfs25-epa-conjugates-adjuvanted-with-alhydrogel%C3%A2
#13
Daming Zhu, Yimin Wu, Holly McClellan, Weili Dai, Kelly Rausch, Dominique Jones, Joan Aebig, Emma Barnafo, Brandi Butler, Lynn Lambert, David L Narum, Patrick E Duffy
Pfs25, a Plasmodium falciparum surface protein expressed during zygote and ookinete stages in infected mosquitoes, is a lead transmission-blocking vaccine candidate against falciparum malaria. To enhance immunogenicity, recombinant Pfs25 was chemically conjugated to recombinant nontoxic Pseudomonas aeruginosa ExoProtein A (rEPA) in conformance with current good manufacturing practices (cGMP), and formulated with the alum adjuvant Alhydrogel. In order to meet the regulatory requirements for a phase 1 human clinical trial, the vaccine product was extensively evaluated for stability at an initial time point and through the clinical trial period annually...
May 31, 2017: Vaccine
https://www.readbyqxmd.com/read/28465692/safety-of-cultivated-limbal-epithelial-stem-cell-transplantation-for-human-corneal-regeneration
#14
REVIEW
J Behaegel, S Ní Dhubhghaill, C Koppen, N Zakaria
Ex vivo cultivated limbal stem cell transplantation is a promising technique for the treatment of limbal stem cell deficiency. While the results of the clinical trials have been extensively reported since the introduction of the technique in 1997, little has been reported regarding the potential health risks associated with production processes and transplantation techniques. Culture procedures require the use of animal and/or human-derived products, which carry the potential of introducing toxic or infectious agents through contamination with known or unknown additives...
2017: Stem Cells International
https://www.readbyqxmd.com/read/28461437/why-on-earth-did-i-buy-that-a-study-of-regretted-appliance-purchases
#15
T Roberts, A Hope, A Skelton
If targets to reduce greenhouse gas emissions and thereby tackle climate change are to be achieved, it will be necessary to reduce both embodied energy costs (e.g. in terms of producing and manufacturing the products and services that society consumes) and operational energy costs. Reducing the number of purchases that people regret could be a first step in changing the overall dynamic of consumption patterns. This research looks at some potentially adverse effects of consumption on well-being (e.g. negative emotions), applying social practice theory to give insights into why people make purchases that they feel negatively about...
June 13, 2017: Philosophical Transactions. Series A, Mathematical, Physical, and Engineering Sciences
https://www.readbyqxmd.com/read/28460522/nanobody-based-immunoassay-for-human-soluble-epoxide-hydrolase-detection-using-polymeric-horseradish-peroxidase-polyhrp-for-signal-enhancement-the-rediscovery-of-polyhrp
#16
Dongyang Li, Yongliang Cui, Christophe Morisseau, Shirley J Gee, Candace S Bever, Xiangjiang Liu, Jian Wu, Bruce D Hammock, Yibin Ying
Soluble epoxide hydrolase (sEH) is a potential pharmacological target for treating hypertension, vascular inflammation, cancer, pain, and multiple cardiovascular related diseases. A variable domain of the heavy chain antibody (termed single domain antibody (sdAb), nanobody, or VHH) possesses the advantages of small size, high stability, ease of genetic manipulation, and ability for continuous manufacture, making such nanobody a superior choice as an immunoreagent. In this work, we developed an ultrasensitive nanobody based immunoassay for human sEH detection using polymeric horseradish peroxidase (PolyHRP) for signal enhancement...
May 10, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28459743/the-use-of-gmp-produced-bone-marrow-derived-stem-cells-in-combination-with-extracorporeal-membrane-oxygenation-in-ards-an-animal-model
#17
Ergin Kocyildirim, Nayra Cárdenes, Antony Ting, Eder Cáceres, Christian BermUdez, Mauricio Rojas
Acute respiratory distress syndrome (ARDS) is the result of a wide variety of disorders, which can be associated with different clinical disorders or systemic diseases directly affecting the lungs. Currently, the only existing therapy is limited to supportive care. In a 6 hour pilot study, we analyzed the use of the combination of both stem cell and extracorporeal membrane oxygenation (ECMO) strategies to prevent or treat severe lung injury. A total of 11 sheep were used. Five sheep received Escherichia coli endotoxin as a control group (group 1)...
May 2017: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
https://www.readbyqxmd.com/read/28450146/alternatives-to-eye-bank-native-tissue-for-corneal-stromal-replacement
#18
REVIEW
Isabelle Brunette, Cynthia J Roberts, François Vidal, Mona Harissi-Dagher, Jean Lachaine, Heather Sheardown, Georges M Durr, Stéphanie Proulx, May Griffith
Corneal blindness is a major cause of blindness in the world and corneal transplantation is the only widely accepted treatment to restore sight in these eyes. However, it is becoming increasingly difficult for eye banks to meet the increasing demand for transplantable tissue, which is in part due to population aging. Donor tissue shortage is therefore a growing concern globally and there is a need for alternatives to human donor corneas. Biosynthetic corneal substitutes offer several significant advantages over native corneas: Large-scale production offers a powerful potential solution to the severe shortage of human donor corneas worldwide; Good manufacturing practices ensure sterility and quality control; Acellular corneal substitutes circumvent immune rejection induced by allogeneic cells; Optical and biomechanical properties of the implants can be adapted to the clinical need; and finally these corneal substitutes could benefit from new advances in biomaterials science, such as surface coating, functionalization and nanoparticles...
April 24, 2017: Progress in Retinal and Eye Research
https://www.readbyqxmd.com/read/28450071/good-cell-culture-practices-in-vitro-toxicology
#19
Chantra Eskes, Ann-Charlotte Boström, Gerhard Bowe, Sandra Coecke, Thomas Hartung, Giel Hendriks, David Pamies, Alain Piton, Costanza Rovida
Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance documents on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes...
April 24, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/28447618/manufacturing-differences-affect-human-bone-marrow-stromal-cell-characteristics-and-function-comparison-of-production-methods-and-products-from-multiple-centers
#20
Shutong Liu, Luis F de Castro, Ping Jin, Sara Civini, Jiaqiang Ren, Jo-Anna Reems, Jose Cancelas, Ramesh Nayak, Georgina Shaw, Timothy O'Brien, David H McKenna, Myriam Armant, Leslie Silberstein, Adrian P Gee, Derek J Hei, Peiman Hematti, Sergei A Kuznetsov, Pamela G Robey, David F Stroncek
Human bone marrow stromal cells (BMSCs, also known as bone marrow-derived mesenchymal stem cells) are manufactured using many different methods, but little is known about the spectrum of manufacturing methods used and their effects on BMSC characteristics and function. Seven centers using, and one developing, Good Manufacturing Practices (GMP) processes were surveyed as to their production methods. Among the seven centers, all used marrow aspirates as the starting material, but no two centers used the same manufacturing methods...
April 27, 2017: Scientific Reports
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