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Clinical translation

Section edited by Lana Kandalaft

This section aims to allow rapid communication of innovative early phase clinical trials, where novel scientific ideas are translated to the clinic. These include clinical trials that are distinguished for their novelty in approach, design or indication, timeliness, and unique ability to translate laboratory concepts from the bench to the bedside. Manuscripts are submitted typically at the time a clinical trial has gained full regulatory approval and is being initiated. No clinical results are required. These articles review the background, rationale, clinical design and approach, translational endpoints and expected outcomes of a new clinical trial in a scholarly manner, and provide the opportunity to investigators to share their views and clinical translation efforts with a wide audience at an early stage.

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  1. Content type: Research

    Chronic myelogenous leukemia (CML) is a hematological stem cell disorder. Tyrosine kinase inhibitors (TKIs) are the standard treatments for CML, but a number of patients fail to respond effectively due to gene...

    Authors: Ying Lu, Ling-Ling Liu, Shou-Sheng Liu, Zhi-Gang Fang, Yong Zou, Xu-Bin Deng, Zi-Jie Long, Quentin Liu and Dong-Jun Lin

    Citation: Journal of Translational Medicine 2016 14:270

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  2. Content type: Research

    Treatment for acute myeloid leukemia (AML) has not significantly changed in the last decades and new therapeutic approaches are needed to achieve prolonged survival rates. Leukemia stem cells (LSC) are respons...

    Authors: María Carmen Lara-Castillo, Josep Maria Cornet-Masana, Amaia Etxabe, Antònia Banús-Mulet, Miguel Ángel Torrente, Meritxell Nomdedeu, Marina Díaz-Beyá, Jordi Esteve and Ruth M. Risueño

    Citation: Journal of Translational Medicine 2016 14:261

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  3. Content type: Research

    TRIM5 and TRIM22 are restriction factors involved in innate immune response and exhibit anti-viral activity. Single nucleotide polymorphisms (SNPs) at TRIM5 and TRIM22 genes have shown to influence several viral ...

    Authors: Luz M. Medrano, Norma Rallón, Juan Berenguer, María A. Jiménez-Sousa, Vicente Soriano, Teresa Aldámiz-Echevarria, Amanda Fernández-Rodríguez, Marcial García, Francisco Tejerina, Isidoro Martínez, José M. Benito and Salvador Resino

    Citation: Journal of Translational Medicine 2016 14:257

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  4. Content type: Research

    Myocardial fibrosis (MF) is a deleterious consequence of aortic valve stenosis (AVS). Global longitudinal strain (GLS) is a novel left ventricular (LV) functional parameter potentially useful to non-invasively...

    Authors: Iacopo Fabiani, Cristian Scatena, Chiara Maria Mazzanti, Lorenzo Conte, Nicola Riccardo Pugliese, Sara Franceschi, Francesca Lessi, Michele Menicagli, Andrea De Martino, Stefano Pratali, Uberto Bortolotti, Antonio Giuseppe Naccarato, Salvatore La Carrubba and Vitantonio Di Bello

    Citation: Journal of Translational Medicine 2016 14:248

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  5. Content type: Research

    The administration of supplemental oxygen to treat ventilatory insufficiency may lead to the formation of reactive oxygen species and subsequent tissue damage. Cytochrome P4501A1 (CYP1A1) can modulate hyperoxi...

    Authors: Jute Richter, Julio Jimenez, Taro Nagatomo, Jaan Toelen, Paul Brady, Thomas Salaets, Flore Lesage, Jeroen Vanoirbeek and Jan Deprest

    Citation: Journal of Translational Medicine 2016 14:247

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  6. Content type: Research

    Mesenchymal stromal cells are a promising option to treat knee osteoarthritis. Their safety and usefulness must be confirmed and the optimal dose established. We tested increasing doses of bone marrow mesenchy...

    Authors: José M. Lamo-Espinosa, Gonzalo Mora, Juan F. Blanco, Froilán Granero-Moltó, Jorge M. Nuñez-Córdoba, Carmen Sánchez-Echenique, José M. Bondía, Jesús Dámaso Aquerreta, Enrique J. Andreu, Enrique Ornilla, Eva M. Villarón, Andrés Valentí-Azcárate, Fermín Sánchez-Guijo, María Consuelo del Cañizo, Juan Ramón Valentí-Nin and Felipe Prósper

    Citation: Journal of Translational Medicine 2016 14:246

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  7. Content type: Research

    Muscle wasting negatively impacts the progress of chronic diseases such as lung cancer (LC) and emphysema, which are in turn interrelated.

    Authors: Anna Salazar-Degracia, David Blanco, Mònica Vilà-Ubach, Gabriel de Biurrun, Carlos Ortiz de Solórzano, Luis M. Montuenga and Esther Barreiro

    Citation: Journal of Translational Medicine 2016 14:244

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  8. Content type: Research

    To study the safety, feasibility and skin effects of irreversible electroporation (IRE) for breast tissue and breast cancer in animal models.

    Authors: Sheng Li, Fei Chen, Lujun Shen, Qi Zeng and Peihong Wu

    Citation: Journal of Translational Medicine 2016 14:238

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  9. Content type: Research

    Ipilimumab (Ipi) improves the survival of advanced melanoma patients with an incremental long-term benefit in 10–15 % of patients. A tumor signature that correlates with this survival benefit could help optimi...

    Authors: Teofila Seremet, Alexander Koch, Yanina Jansen, Max Schreuer, Sofie Wilgenhof, Véronique Del Marmol, Danielle Liènard, Kris Thielemans, Kelly Schats, Mark Kockx, Wim Van Criekinge, Pierre G. Coulie, Tim De Meyer, Nicolas van Baren and Bart Neyns

    Citation: Journal of Translational Medicine 2016 14:232

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  10. Content type: Research

    Though outcome models have been proposed previously, it is unknown whether cutoffs in clinical pregnancy and live birth rates at all ages are able to classify in vitro fertilization (IVF) patients into good-, ...

    Authors: Norbert Gleicher, Vitaly A. Kushnir, Aritro Sen, Sarah K. Darmon, Andrea Weghofer, Yan-Guang Wu, Qi Wang, Lin Zhang, David F. Albertini and David H. Barad

    Citation: Journal of Translational Medicine 2016 14:172

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  11. Content type: Research

    The nasal mucosa plays a key role in conditioning the inhaled air and in regulating the immune response. These functions led many authors to recommend mucosal sparing techniques for the surgical management of...

    Authors: Giampiero Neri, Fiorella Cazzato, Valentina Mastronardi, Mara Pugliese, Maria Antonietta Centurione, Roberta Di Pietro and Lucia Centurione

    Citation: Journal of Translational Medicine 2016 14:164

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  12. Content type: Research

    The genome of multiple myeloma (MM) cells is extremely unstable, characterized by a complex combination of structure and numerical abnormalities. It seems that there are several “myeloma subgroups” which diffe...

    Authors: Fedor Kryukov, Pavel Nemec, Lenka Radova, Elena Kryukova, Samuel Okubote, Jiri Minarik, Zdena Stefanikova, Ludek Pour and Roman Hajek

    Citation: Journal of Translational Medicine 2016 14:150

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  13. Content type: Research

    Many HIV infected individuals with suppressed viral loads experience chronic immune activation frequently developing neurological impairment designated as HIV associated neurocognitive disorder (HAND). Adjunct...

    Authors: Jeffrey S. Barrett, Sergei Spitsin, Ganesh Moorthy, Kyle Barrett, Kate Baker, Andrew Lackner, Florin Tulic, Angela Winters, Dwight L. Evans and Steven D. Douglas

    Citation: Journal of Translational Medicine 2016 14:148

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  14. Content type: Research

    Chronic fatigue syndrome (CFS) is a common and disabling disorder, and a major threat against adolescent health. The pathophysiology is unknown, but alteration of neuroendocrine control systems might be a cent...

    Authors: Vegard Bruun Wyller, Valieria Vitelli, Dag Sulheim, Even Fagermoen, Anette Winger, Kristin Godang and Jens Bollerslev

    Citation: Journal of Translational Medicine 2016 14:121

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    The Erratum to this article has been published in Journal of Translational Medicine 2017 15:157

  15. Content type: Research

    SCLC has limited treatment options and inadequate preclinical models. Promising activity of arsenic trioxide (ASO) recorded in conventional preclinical models of SCLC supported the clinical evaluation of ASO i...

    Authors: Taofeek K. Owonikoko, Guojing Zhang, Hyun S. Kim, Renea M. Stinson, Rabih Bechara, Chao Zhang, Zhengjia Chen, Nabil F. Saba, Suchita Pakkala, Rathi Pillai, Xingming Deng, Shi-Yong Sun, Michael R. Rossi, Gabriel L. Sica, Suresh S. Ramalingam and Fadlo R. Khuri

    Citation: Journal of Translational Medicine 2016 14:111

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  16. Content type: Protocol

    Compelling evidence has been accumulated to support the effectiveness of intensive lifestyle intervention in delaying progression to Type 2 diabetes even in people identified as being at high risk determined b...

    Authors: Bernardo Costa, Conxa Castell, Xavier Cos, Claustre Solé, Santiago Mestre, Marta Canela, Antoni Boquet, Joan-Josep Cabré, Francisco Barrio, Gemma Flores-Mateo, Daniel Ferrer-Vidal and Jaana Lindström

    Citation: Journal of Translational Medicine 2016 14:103

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  17. Content type: Research

    Acute appendicitis is a common cause for a visit to the emergency department and appendectomy represents the most common emergency procedure in surgery. The rate of negative appendectomy however has remained h...

    Authors: Peter C. Ambe, Daniel Gödde, Lars Bönicke, Marios Papadakis, Stephan Störkel and Hubert Zirngibl

    Citation: Journal of Translational Medicine 2016 14:107

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  18. Content type: Research

    BRAF V600 mutant circulating cell-free tumor DNA (BRAF V600mut ctDNA) could serve as a specific biomarker in patients with BRAF V600 mutant melanoma. We analyzed the value of BRAF V600...

    Authors: Max Schreuer, Geert Meersseman, Sari Van Den Herrewegen, Yanina Jansen, Ines Chevolet, Ambre Bott, Sofie Wilgenhof, Teofila Seremet, Bart Jacobs, Ronald Buyl, Geert Maertens and Bart Neyns

    Citation: Journal of Translational Medicine 2016 14:95

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  19. Content type: Research

    Osteoarthritis (OA) is characterized by progressive loss of cartilage in joints, and is a major cause of pain and disability, and imposes significant health care expense. New therapies are being developed to t...

    Authors: Mohammad Haris, Anup Singh, Sanjana Reddy, Puneet Bagga, J. Bruce Kneeland, Fotios P. Tjoumakaris, Hari Hariharan, Francesco M. Marincola and Ravinder Reddy

    Citation: Journal of Translational Medicine 2016 14:92

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  20. Content type: Research

    The mechanism of action of imatinib is known to involve the Fas-mediated apoptosis pathway. Consequently inter-individual variations in this apoptosis pathway might be associated with imatinib response or resi...

    Authors: Qiaoli Zheng, Jiang Cao, Nada Hamad, Hyeoung-Joon Kim, Joon Ho Moon, Sang Kyun Sohn, Chul Won Jung, Jeffrey H. Lipton and Dennis Dong Hwan Kim

    Citation: Journal of Translational Medicine 2016 14:82

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  21. Content type: Research

    Typhoid fever, caused by the human-restricted organism Salmonella Typhi (S. Typhi), is a major public health problem worldwide. Development of novel vaccines remains imperative, but is hampered by an incomplete u...

    Authors: Stephanie Fresnay, Monica A. McArthur, Laurence Magder, Thomas C. Darton, Claire Jones, Claire S. Waddington, Christoph J. Blohmke, Brian Angus, Myron M. Levine, Andrew J. Pollard and Marcelo B. Sztein

    Citation: Journal of Translational Medicine 2016 14:62

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  22. Content type: Review

    Kidney transplantation is the treatment of choice in patients with end stage renal disease. During kidney transplantation ischemia reperfusion injury (IRI) occurs, which is a risk factor for acute kidney injur...

    Authors: T. C. Saat, E. K. van den Akker, J. N. M. IJzermans, F. J. M. F. Dor and R. W. F. de Bruin

    Citation: Journal of Translational Medicine 2016 14:20

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  23. Content type: Protocol

    Labour is perhaps the most hazardous time in pregnancy. As many as 20 % of cerebral palsy cases in term infants result from intrapartum events and up to 63 % of babies who develop intrapartum compromise have n...

    Authors: Liam Dunn, Vicki Flenady and Sailesh Kumar

    Citation: Journal of Translational Medicine 2016 14:15

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  24. Content type: Research

    Clinical diagnostic research relies upon the collection of tissue samples, and for those samples to be representative of the in vivo situation. Tissue collection procedures, including post-operative ischemia, ...

    Authors: Florian T. Unger, Nicole Lange, Jana Krüger, Carolyn Compton, Helen Moore, Lokesh Agrawal, Hartmut Juhl and Kerstin A. David

    Citation: Journal of Translational Medicine 2016 14:6

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  25. Content type: Commentary

    Alliance Against Cancer (ACC) was established in Rome in 2002 as a consortium of six Italian comprehensive cancer centers (Founders). The aims of ACC were to promote a network among Italian oncologic instituti...

    Authors: Paolo De Paoli, Gennaro Ciliberto, Manlio Ferrarini, PierGiuseppe Pelicci, Paolo Dellabona, Francesco De Lorenzo, Alberto Mantovani, Pellegrino Musto, Giuseppe Opocher, Piero Picci, Walter Ricciardi and Ruggero De Maria

    Citation: Journal of Translational Medicine 2015 13:360

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  26. Content type: Research

    Renal fibrosis is a main cause of end-stage renal disease. Clinically, there is no beneficial treatment that can effectively reverse the progressive loss of renal function. We recently synthesized a novel prot...

    Authors: Cheng Yang, Ye Cao, Yi Zhang, Long Li, Ming Xu, Yaqiu Long, Ruiming Rong and Tongyu Zhu

    Citation: Journal of Translational Medicine 2015 13:355

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  27. Content type: Protocol

    Atrial fibrillation is a progressive arrhythmia, the exact mechanism underlying the progressive nature of recurrent AF episodes is still unknown. Recently, it was found that key players of the protein quality ...

    Authors: Eva A. H. Lanters, Denise M. S. van Marion, Charles Kik, Herman Steen, Ad J. J. C. Bogers, Maurits A. Allessie, Bianca J. J. M. Brundel and Natasja M. S. de Groot

    Citation: Journal of Translational Medicine 2015 13:347

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  28. Content type: Editorial

    Opinion-based commentary about the complex reality of being a clinician-scientist in today’s modern biomedical environment. The essay uses the beautiful, but old, poem “If” from Rudyard Kipling to draw a paral...

    Authors: Pierre R. Smeesters

    Citation: Journal of Translational Medicine 2015 13:345

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  29. Content type: Research

    Many kidneys are rejected for transplantation due to inadequate in situ perfusion during organ retrieval because of the risk of additional ischaemic injury and microvasculature thrombosis. This study describes...

    Authors: Sarah A. Hosgood, A. D. Barlow, J. Dormer and M. L. Nicholson

    Citation: Journal of Translational Medicine 2015 13:329

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  30. Content type: Research

    There is growing evidence that variations in the gene encoding inosine triphosphate pyrophosphohydrolase (ITPase), known as inosine triphosphatase (ITPA), are related to hemolytic anemia, which is frequently obse...

    Authors: Daniel Pineda-Tenor, Mónica García-Álvarez, María A. Jiménez-Sousa, Sonia Vázquez-Morón and Salvador Resino

    Citation: Journal of Translational Medicine 2015 13:320

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  31. Content type: Research

    The strategy of using fecal microbiota transplantation (FMT) for refractory ulcerative colitis (UC) remains unclear if single FMT failed to induce remission. This study aimed to evaluate the efficacy and safet...

    Authors: Bota Cui, Pan Li, Lijuan Xu, Youquan Zhao, Huiquan Wang, Zhaoyuan Peng, Hai’e Xu, Jie Xiang, Zhi He, Ting Zhang, Yongzhan Nie, Kaichun Wu, Daiming Fan, Guozhong Ji and Faming Zhang

    Citation: Journal of Translational Medicine 2015 13:298

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  32. Content type: Research

    NK cells can destroy tumor cells without prior sensitization or immunization. Tumors often lose expression of MHC molecules and/or antigens. However, NK cells can lyse tumor cells in a non-MHC-restricted manne...

    Authors: Naoyuki Sakamoto, Takeshi Ishikawa, Satoshi Kokura, Tetsuya Okayama, Kaname Oka, Mitsuko Ideno, Fumiyo Sakai, Akiko Kato, Masashige Tanabe, Tatsuji Enoki, Junichi Mineno, Yuji Naito, Yoshito Itoh and Toshikazu Yoshikawa

    Citation: Journal of Translational Medicine 2015 13:277

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  33. Content type: Review

    The latest high-throughput sequencing technologies show that there are more than 1000 types of microbiota in the human gut. These microbes are not only important to maintain human health, but also closely rela...

    Authors: Weilin Wang, Shaoyan Xu, Zhigang Ren, Jianwen Jiang and Shusen Zheng

    Citation: Journal of Translational Medicine 2015 13:275

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  34. Content type: Review

    In human medicine clinical trials are legally required for drug development and approval. In contrast, clinical trials in small animal cancer patients are less common and legally perceived as animal experiment...

    Authors: Irene Fürdös, Judit Fazekas, Josef Singer and Erika Jensen-Jarolim

    Citation: Journal of Translational Medicine 2015 13:265

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  35. Content type: Research

    The American College of Obstetrics and Gynecology (ACOG) and Maternal Fetal Medicine (MFM) Societies recommended that abnormal cfDNA fetal results should be confirmed by amniocentesis and karyotyping. Our results...

    Authors: Roger V Lebo, Robert W Novak, Katherine Wolfe, Melonie Michelson, Haynes Robinson and Melissa S Mancuso

    Citation: Journal of Translational Medicine 2015 13:260

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  36. Content type: Research

    In clinic settings, rel apsed leukemic patients are found to be more fragile to chemotherapy due to delayed or incomplete hematopoietic recovery, and hematopoiesis of these patients seem to be impaired.

    Authors: Chuanhe Jiang, Xiaoxia Hu, Libing Wang, Hui Cheng, Yan Lin, Yakun Pang, Weiping Yuan, Tao Cheng and Jianmin Wang

    Citation: Journal of Translational Medicine 2015 13:234

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  37. Content type: Research

    The failure in standard triple therapy has recently increased to high levels in China, primarily because of insufficient patient compliance, antimicrobial resistance, and high costs. Effective prevention and e...

    Authors: Dailun Hu, Feng Zhang, Jikun Zhou, Baohong Xu, Hongying Zhang, Huiqin Qiang, Shuguang Ren, Baoen Shan, Changfu Yin, Zhitao Zhang, Xian Wang, Chuan Zhao and Zhongli Shi

    Citation: Journal of Translational Medicine 2015 13:205

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  38. Content type: Research

    Corticosteroids are preferred to treat patients with active IgA nephropathy (IgAN), and beneficial effects from the short-term use of corticosteroids have been confirmed. However, a large number of patients wi...

    Authors: Yanhong Yuan, Qin Wang, Zhaohui Ni, Xiajing Che, Liou Cao, Xinghua Shao, Minfang Zhang, Yuanyuan Xie, Chaojun Qi, Wenyan Zhou, Lei Tian and Shan Mou

    Citation: Journal of Translational Medicine 2015 13:186

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  39. Content type: Research

    Influenza H5N1 is one subtype of the influenza A virus which can infect human bodies and lead to death. Timely diagnosis before its breakout is vital to the human health. The current clinical biochemical diagn...

    Authors: Min Zhu, Xue Gong, Yonghong Hu, Weijun Ou and Yakun Wan

    Citation: Journal of Translational Medicine 2014 12:352

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  40. Content type: Protocol

    Although the efficacy of zoledronic acid in postmenopausal women with breast cancer has been suggested, the underlying mechanism has not been fully clarified. Therefore, which patients may benefit from zoledro...

    Authors: Eriko Sumi, Tomoharu Sugie, Kenichi Yoshimura, Harue Tada, Takafumi Ikeda, Eiji Suzuki, Yoshimasa Tanaka, Satoshi Teramukai, Akira Shimizu, Masakazu Toi and Nagahiro Minato

    Citation: Journal of Translational Medicine 2014 12:310

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  41. Content type: Research

    Hereditary hearing loss is genetically heterogeneous, and hundreds of mutations in than 60 genes are involved in this disease. Therefore, it is difficult to identify the causative gene mutations involved. In t...

    Authors: Qinjun Wei, Hongmei Zhu, Xuli Qian, Zhibin Chen, Jun Yao, Yajie Lu, Xin Cao and Guangqian Xing

    Citation: Journal of Translational Medicine 2014 12:311

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  42. Content type: Protocol

    Tumor cells killed by radiation therapy (RT) are a potentially good source of antigens for dendritic cell (DC) uptake and presentation to T-cells. RT upregulates cell death receptors such as Fas/CD95 and MHC-I...

    Authors: Laura Ridolfi, Francesco de Rosa, Ruggero Ridolfi, Giorgia Gentili, Linda Valmorri, Emanuela Scarpi, Elisabetta Parisi, Antonino Romeo and Massimo Guidoboni

    Citation: Journal of Translational Medicine 2014 12:262

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  43. Content type: Research

    Umbilical cord mesenchymal stem cells (UCMSCs) have a considerable advantage and potential in treating for central nervous system diseases and have become a novel alternative treatment for spinal cord injury. ...

    Authors: Hongbin Cheng, Xuebin Liu, Rongrong Hua, Guanghui Dai, Xiaodong Wang, Jianhua Gao and Yihua An

    Citation: Journal of Translational Medicine 2014 12:253

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  44. Content type: Research

    Accurate estimation of a burned area is crucial to decisions about fluid resuscitation, surgical options, nutritional support, and prognosis. Widely used clinical methods to estimate a burn area are two-dimens...

    Authors: Wen-bo Sheng, Ding Zeng, Yan Wan, Li Yao, Hong-tai Tang and Zhao-fan Xia

    Citation: Journal of Translational Medicine 2014 12:242

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  45. Content type: Research

    Human placenta releases specific nanovesicles (i.e. exosomes) into the maternal circulation during pregnancy, however, the presence of placenta-derived exosomes in maternal blood during early pregnancy remains to...

    Authors: Suchismita Sarker, Katherin Scholz-Romero, Alejandra Perez, Sebastian E Illanes, Murray D Mitchell, Gregory E Rice and Carlos Salomon

    Citation: Journal of Translational Medicine 2014 12:204

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  46. Content type: Protocol

    Vaccination with dendritic cells (DC) loaded with tumor antigens elicits tumor-specific immune responses capable of killing cancer cells without inducing meaningful side-effects. Patients with advanced melanom...

    Authors: Francesco de Rosa, Laura Ridolfi, Ruggero Ridolfi, Giorgia Gentili, Linda Valmorri, Oriana Nanni, Massimiliano Petrini, Laura Fiammenghi, Anna Maria Granato, Valentina Ancarani, Elena Pancisi, Valentina Soldati, Serena Cassan, Angela Riccobon, Elisabetta Parisi, Antonino Romeo…

    Citation: Journal of Translational Medicine 2014 12:209

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  47. Content type: Methodology

    Rapidly determining the complex genetic basis of Hypertrophic cardiomyopathy (HCM) is vital to better understanding and optimally managing this common polygenetic cardiovascular disease.

    Authors: Zongzhe Li, Jin Huang, Jinzhao Zhao, Chen Chen, Hong Wang, Hu Ding, Dao Wu Wang and Dao Wen Wang

    Citation: Journal of Translational Medicine 2014 12:173

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  48. Content type: Research

    Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a multi-system illness characterized, in part, by increased fatigue following minimal exertion, cognitive impairment, poor recovery to physical an...

    Authors: Betsy A Keller, John Luke Pryor and Ludovic Giloteaux

    Citation: Journal of Translational Medicine 2014 12:104

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