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Castel Guelfo di Bologna, Italy

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.2.4.1-1 | Award Amount: 7.56M | Year: 2013

Ewing Sarcomas (ES) are fatal, rare bone cancers particularly affecting young people. About 60% of patients achieve long term survival with current treatment but there has been no improvement in this proportion for 25 years. Treatment is unsuccessful because chemotherapy fails to prevent the development of, or to effectively treat established, metastases. In addition, of the 600 new cases of ES occurring in the EU each year, less than half will receive treatment appropriate to deliver the most favourable outcome. The EUROEWING Consortium (EEC) is a coalition of clinical study groups bringing together the most active clinicians and scientists in Europe dedicated to improving survival from ES. This initiative can achieve this through an integrated programme of investigator-driven, inclusive clinical trials that are rigorously designed, conducted, analysed and reported, and underpinned by complementary embedded translational research. These include i) a first line randomised study in patients of all ages with ES which defines standards of care to prevent development of metastases and serves as a backbone for implementation of new agents, and ii) a randomised study of current second line chemotherapy in patients of all ages with ES which will serve as a platform for testing of new agents. Companion studies in association with these trials will be performed investigating tumour biology, underlying causes of differential response and toxicity, and other biomarkers. The programme will be supported by new initiatives for the involvement of patients in research planning and operation. Through collaborative working, the EEC will provide ES patients with greater access to clinical trials, allow efficient acquisition of knowledge and deliver clinically meaningful results within the lifetime of the grant, thereby contributing to improved survival from ES.

Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2009.5.3 | Award Amount: 14.33M | Year: 2011

VPH-Share will develop the organisational fabric (the infostructure) and integrate the optimised services to (1) expose and share data and knowledge, (2) jointly develop multiscale models for the composition of new VPH workflows, (3) facilitate collaborations within the VPH community. Four flagship workflows (from @neurIST, euHeart, VPHOP, Virolab) provide existing data, tools and models, engage with the services developed by VPH-Share to drive the development of the infostructure, and pilot its applications. Data sources are usually clinical data from individual patients - medical images and/or biomedical signals - sometimes with population information. The operations range from secure access and storage through annotation, data inference and assimilation, to complex image processing and physics-based mathematical modelling, to data reduction and representation. The project focuses on a key bottleneck: the interface with the wealth of data from medical research infrastructures and from clinical processes. VPH-Share will provide the essential services, as well as the computational infrastructure, for the sharing of clinical and research data and tools, facilitating the construction and operation of new VPH workflows, and collaborations between the members of the VPH community. Evaluating the effectiveness and fitness-for-purpose of the infostructure and developing a thorough exploitation strategy are key activities, creating confidence in the communities. The consortium, through its optimal mix of medical, mathematical, engineering, software & hardware and industrial knowledge and expertise from the EU and internationally, will make this effort a success, delivering to European citizens clinically useful outcomes that will benefit society. The duration of the project is 4 years, its budget is 14.3M, with an EC contribution of 10.7M.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.2.4.1-1 | Award Amount: 7.88M | Year: 2011

Sarcomas are rare malignant tumors, with an overall incidence of 6/105/year. Bone and soft tissue connective tissue tumours encompass more than 50 different rare histotypes and more than 150 different molecular subtypes. The incidence of individual rare sarcomas subtypes is often less than 0.5/105/year. Given sarcoma rarity as a group, but even more as individual entities, few prospective clinical trials testing local or systemic treatments have been performed in specific subtypes of sarcomas. Clinical trials in specific histological and molecular subtypes of sarcoma can only be performed through integrated clinical networks, centres of clinical excellence, supported by translational analysis. The drive for EUROSARC comes from the fact that sarcomas should now receive treatment adapted to histological and molecular subtypes and are ideal models to develop rational oncogene-targeted therapies. Trials based on selected molecular subtypes should now represent the standard approach to delineate novel treatments in individual disease subsets. They are also potential proof of concepts for first-in-class targeted treatment. EUROSARC aims at validating 1) novel local and systemic treatment strategies in localized phase, and 2) innovative targeted therapies in advanced phase based on the scientific understanding of molecular alterations driving the tumours thereby developing paradigm changing clinical research. The consortium builds on the successful co-ordination of scientific excellence of Conticanet and EuroBoNeT FP6 NoEs, where most partners were involved. The objective will be achieved through the development and conduct of 9 (2Soft tissues \ 7Bones, 9 phase I/II and III) investigator-driven clinical trials in rare histological and molecular subtypes of sarcoma, through the establishment of an integrated consortium, gathering representatives of most European sarcoma groups, SME, all with proven track records of scientific and clinical excellence.

Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-15-2014 | Award Amount: 6.00M | Year: 2015

Osteoarthritis (OA) is an incurable disease that has evaded pharmacological interference, biologic therapy or surgical intervention to prevent disease progression. Currently, OA is designated the 11th highest contributor (of 291 diseases) of global disability. In the absence of effective treatment options, cellular therapies using mesenchymal stem/stromal cells (MSCs) have emerged as potential candidates to overcome this clinical short-coming. Autologous adipose-derived mesenchymal stromal cells (ASCs) are attractive for cellular therapy given the abundance of tissue, high frequency of MSCs and minimally invasive harvest procedure. The EU consortium ADIPOA has shown in a first in man 2-centre Phase I safety study that intraarticular injection of a single dose of autologous ASCs to the knee (18 patients, 12 month follow-up) was well-tolerated, had no adverse effects, and resulted in an improvement in pain score and functional outcome. ADIPOA2 will deliver a large-scale clinical trial in regenerative medicine for OA. The purpose of the project is to design and implement a phase IIb study to assess the safety and efficacy of autologous (patient-derived) ACSs in the treatment of advanced OA of the knee. The cells will be prepared from samples of adipose tissue harvested from patients by lipoaspiration. ADIPOA2 will comprise a multi-centre, randomized clinical trial comparing culture-expanded, autologous adult ASCs in subjects with knee OA with another widely used therapeutic approach for knee degeneration (injection of Hyaluronan). There are two large elements of the study: (1) the production of consistent batches of high-quality autologous ASCs under GMP-compliant conditions and (2) delivery of these cell doses to patients in a trial which will meet all national and European regulatory and ethical standards and which will have sufficient statistical power to provide an unambiguous and definitive assessment of safety and efficacy.

Longhi A.,Istituto Ortopedico Rizzoli
Ear, nose, & throat journal | Year: 2011

Aggressive fibromatosis (desmoid tumor) of the neck is rare. When feasible, surgery is the best treatment option. However, complete excision with negative margins is not possible in most cases because of the involvement of vascular and nervous structures. Also, surgery results in poor functional and aesthetic outcomes. Sometimes debulking surgery with positive margins is performed, but the anatomy of the neck is a challenge for oncologic surgeons, and recurrences are not uncommon. Radiotherapy is seldom employed for the same reasons. On the other hand, systemic treatment with chemotherapy, hormone therapy, and noncytotoxic agents such as nonsteroidal anti-inflammatory drugs (NSAIDs) has been used with good results. We report a case of inoperable aggressive fibromatosis of the neck that was successfully treated for about 21 months with a combination of chemotherapy and the NSAID indomethacin. As far as we know, this is the first reported use of a combination of chemotherapy and an anti-inflammatory drug in the treatment of aggressive fibromatosis of the neck. We also review the literature on cases of aggressive fibromatosis of the neck that have been reported over the past 12 years. Source

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