Agency: Cordis | Branch: H2020 | Program: RIA | Phase: ICT-26-2014 | Award Amount: 3.39M | Year: 2015
The diagnosis and management of acute Sepsis is a critical area where fast and accurate results can translate into life changing health outcomes for individuals. The overall aim of RAIS is to develop a new point-of-care label-free microarray platform and validate it for quantifying levels of specific Sepsis biomarkers. The approach uses a novel interferometric technique ultimately capable of providing very large arrays of tests. Specific objectives and activities include: (i) an optical microarray reader based on a disruptive proprietary design combining interferometric lens-free microscopy and proximity CCD or CMOS image sensing; (ii) a microarray plate, in a proper microfluidic cartridge, consisting of a transparent slide with a novel nano-structured surface geometry to increase the detection sensitivity and covered by specific receptors to capture bio-markers; (iii) their integration in a portable and battery powered label free microarray platform potentially capable of measuring more than 1 million bio-targets simultaneously. The developed technology will be capable to detect micro-ribonucleic acids (microRNAs), interleukins and other specific proteins associated to Sepsis using a few microliters of blood or serum samples, in a concentration of a few pg/ml, within 30 minutes (sample to result) and at a cost per patient of less than 50. In this way, patients will be put on the right treatment more rapidly, potentially reducing the Sepsis mortality rate of more than 70%, with estimated cost savings of more than 10 billion per year as a consequence of shorter hospital stays, reduced use of unnecessary drugs and lower associated insurance bills. The technical approach, targeted device, application and the addressed market sector are perfectly in line with the call H2020-ICT-2014-1 - Photonics KET - Biophotonics for screening of diseases: Mobile, low-cost point-of-care screening devices for reliable, fast and non- or minimally-invasive detection of diseases.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.2.4.3-1 | Award Amount: 7.76M | Year: 2012
Diabetic retinopathy (DR), the leading cause of blindness among working-age individuals in developed countries has been classically considered to be a microcirculatory disease of the retina. However, there is growing evidence to suggest that retinal neurodegeneration is an early event in the pathogenesis of DR. For this reason, it is reasonable to hypothesize that therapeutic strategies based on neuroprotection will be effective not only in preventing or arresting retinal neurodegeneration but also in preventing the development and progression of the early stages of DR (ie. microaneurysms and/or retinal thickness). EUROCONDOR (European Consortium for the Early Treatment of Diabetic Retinopathy) is a solid and well balanced consortium (ophthalmologists, endocrinologists, basic researchers) which has been created in order to implement the first clinical trial using eye drops for treatment of the early stages of DR. The participants are top leaders in their field and central readings will be performed by the Coordinating Centre of the European Vision Institute Clinical Research Network (EVICR.Net). The main objectives of the project are the following: Primary objective: To assess whether the selected neuroprotective drugs (brimonidine and somatostatin) administered topically are able to prevent or arrest neurodegeneration, as well as the development and progression of the early stages of DR. Secondary objectives: 1) To determine the prevalence of functional abnormalities related to neurodegeneration in those patients without or with minimal microvascular damage under ophthalmoscopic examination. 2) To compare the effectiveness of the selected drugs. 3) To evaluate the local and systemic adverse effects of the selected drugs. 4) To identify those patients most prone to progressive worsening (characterization of phenotypes and circulating biomarkers). 5) To determine the molecular mechanisms by which the selected drugs exert their beneficial effects.
BIO-DRIM - Personalized minimization of immunosuppression after solid organ transplantation by biomarker-driven stratification of patients to improve long-term outcome and health-economic data of transplantation
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.1.4-1 | Award Amount: 7.98M | Year: 2012
Organ transplantation has emerged as the gold standard therapy for end-stage organ failure. Incomplete control of chronic allograft injury but also the adverse effects of long-term immunosuppression (IS) continue to challenge the long-term success of transplantation. The paradigm is shifting from increasing net-IS by novel drugs to the concept of minimizing long-term IS as early as possible. However, data were almost completely generated by trial-and-error observational studies. It suggests an unmet need to stratify transplant (Tx) patients regarding their immunological responsiveness to the allograft and their respective individual need of IS. The central focus of the project is the implementation of biomarker-driven strategies for personalizing IS to improve the long-term outcome and to decrease the adverse effects and costs of chronic IS. This includes 5 innovative investigator-driven biomarker clinical trials designed by the consortium with >1800 (screening) / 1000 (trial) patients. The following issues will be addressed: -targeted complete/partial weaning of standard IS in long-term stable liver and kidney Tx patients identified as operationally tolerant by recently developed biomarker panels-prevention of CNI-based standard IS in low-responder kidney Tx recipients by perioperative biomarker-based stratification-shifting high to low-responder kidney Tx patients suitable for early minimisation by the recently explored selective targeting of alloreactive effector/memory T cells -implementing new biomarker candidates supporting personalized IS within the clinical trials-analysing the health-economic impact of biomarker-guided personalized IS -studying the mechanisms behind successful weaning (regulation/effector balance) -disseminating the results and developing commercialisation by partnering with SME/industry. The project will take advantage and exploit recent research findingsIndices of Tolerance (IOT) and RISET but also of other international groups.
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.4.4-1 | Award Amount: 7.00M | Year: 2013
Fanconi anemia (FA) is a rare inherited syndrome characterized by the early development of bone marrow failure and increasing predisposition to cancer with age. Allogeneic hematopoietic cell transplantation (alloHCT) is the only curative therapy for hematopoietic manifestations of FA, although associated with complications arising from myeloablation, graft versus host disease and increased incidence of squamous cell carcinoma. The genetic correction of autologous hematopoietic stem cells (HSC) with lentiviral vectors constitutes a recent and safe alternative for the treatment of different genetic diseases affecting mature cells from different tissues and/or committed progenitors of the hematopoietic system. One of the key features of FA that make it a unique disease for gene therapy approaches rely on the characteristic proliferation defect that is already evident in the very primitive HSCs. Thus, a marked survival advantage would be expected from corrected HSCs, potentially allowing normalization of hematopoiesis in the absence or after mild conditioning. Difficulties in the collection of sufficient numbers of HSC from FA patients and the use of sub-optimal transduction protocols with gammaretroviral vectors limited the success of FA gene therapy trials conducted 10 years ago in the USA. Our innovative approach to develop for the first time an efficient and safe gene therapy of FA is based on two recent innovations: 1) Discovery of potent HSC mobilizers, such as plerixafor, and 2) Development of a new lentiviral vector by members of this Consortium, designed as Orphan Drug by the EC in December 2010. The principal objective of this Project is, therefore, the development of a multicentric Phase I/II gene therapy trial for FA-A patients, based on the genetic correction of plerixafor\G-CSF mobilized HSCs with the novel lentiviral vector, accompanied by comprehensive and groundbreaking safety and efficacy patient monitoring studies.
Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-06-2014 | Award Amount: 2.95M | Year: 2015
Chronic kidney disease (CKD) is an important public health problem worldwide, especially in older people. Indeed, population aging in industrialized countries is accompanied by an increase in the prevalence of CKD and its complications. Although its prevalence and the importance of an early diagnosis to prevent complications such as end-renal stage disease (ESRD), screening programme in Europe are highly heterogeneous, fragmented, being in most cases based on opportunistic rather than structured assessments of patients. The main objective of the SCOPE project is to evaluate a large scale screening programme for CKD in the older population (age 75\) in Europe. Specific objectives are (i) to assess existing methodologies to screen for CKD among older adults, including the use of Comprehensive Geriatric Assessments (CGA); (ii) to investigate innovative biomarkers potentially useful for CKD screening; (iii) to evaluate the cost-effectiveness of CKD screening in a population at high risk of kidney function decline and ESRD; (iv) to provide evidence for further development of European recommendations, as well as an education programme in this field. This will be achieved also thanks to the creation of a large observational database including a cohort of older people aged 75 years or more, enrolled within the framework of an observational, multinational, multicenter, prospective study with a 2-year follow up. The SCOPE database will include a CGA-based screening and a collection of biological samples at baseline and at regular intervals during the study. The SCOPE project will provide evidence for the increased use, or discontinuation of, existing screening and prevention programmes in the field of CKD, allowing informed decisions by policymakers. It will contribute to capacity building in the assessment of such screening and prevention programmes in an equitable and cost-effective manner, thus improving health outcomes in the older European population.