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Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.1.4-3 | Award Amount: 9.64M | Year: 2012

Chronic kidney disease (CKD) affects 8% of the European population and ultimately results in renal failure due to progressive fibrosis. CDK carries a high mortality risk and the number of affected people rises, increasing the demand on renal replacement therapies while the number of available donor organs stays stable. The STELLAR consortium proposes to develop an alternative to renal replacement therapy, based on the repair capacity of newly discovered kidney mesenchymal stromal cells (kMSCs). By injecting kMSC into affected kidneys, we expect to stop kidney fibrosis and induce tissue repair, ultimately leading to the restoration of normal kidney function. The STELLAR consortium will develop protocols for up scalable, high quality isolation of kMSCs and precisely characterize kMSC function in comparison to other MSCs. test kMSCs in several murine renal disease models, to study their effects on fibrosis and tissue repair. discover mechanisms of kidney repair. invest in developing the technology necessary for up scaled isolation and quality control. The STELLAR consortium combines Australian experts on kMSC isolation and characterisation with European experts on renal failure and compounds the state-of-the-art knowledge, facilities and experience needed to develop and validate this novel form of renal therapy. The inclusion of experienced SMEs, with great technical and scientific know-how about assay and protocol development, further strengthens the consortium and will ensure not only the inclusion of new technology, but also a quick translation from bench to clinical application. In conclusion, the STELLAR consortium is capable of developing and pre clinical validation of this new cellular therapy for CDK, based on a new understanding of stromal cells and fibroblast function, while also providing the technology required for rapid, large scale application of the therapy after clinical validation.

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: HEALTH-2009-2.4.5-2 | Award Amount: 15.74M | Year: 2010

Chronic kidney disease (CKD) affects up to 10% of the population. Besides eventual progression towards end stage renal disease CKD impacts the patients quality of life by causing serious comorbidities including cardiovascular complications and bone metabolism disorders. On the everyday clinical level early stage diagnosis and tailored treatment of CKD are still inadequate. In addition, CKD seems not to have reached its appropriate emplacement in an epidemiological and healthcare perspective yet, and the pathophysiology of the disease on a molecular and cellular level is not well enough understood. Our sysKID consortium was installed for precisely addressing these issues: To unravel the molecular and cellular mechanisms of chronic kidney disease development, combine this information with clinical risk factors, and on this basis delineate chronic kidney disease biomarkers. These markers will allow us to perform preclinical studies of novel therapy approaches for halting disease progression, and will provide us with the materials for development and clinical evaluation of tools for early stage diagnosis as well as prognosis and treatment monitoring. sysKID assures a successful implementation of these goals by a truly international consortium of 27 leading research groups. We combine clinical know how, provide access to a huge chronic kidney disease sample and clinical data pool, and build a Systems Biology framework for chronic kidney disease by integrating molecular and cellular biology, computational biology, statistics and epidemiology. Our expert group is further complemented by a high level advisory board covering science, product development, and the patients perspective. sysKID implementation is structured for completing pre-clinical Proof of Concept studies of novel chronic kidney disease therapy regimes, and further for completing clinical evaluation of an epidemiological screening tool as well as of early stage chronic kidney disease diagnostic kits.

Agency: Cordis | Branch: H2020 | Program: SME-1 | Phase: PHC-12-2015-1 | Award Amount: 71.43K | Year: 2015

In Europe and US about 12 million women are pregnant every year. 2 % to 8 % are affected by pre-eclampsia and intra uterine growth restriction. And more dramatically worldwide more than 50,000 mothers and babies are dying yearly due to undetected pre-eclampsia. Accuracy and prognostic performance of the current gold standard diagnosis, relying on blood pressure and urinary protein measurement, are relatively poor. Thus a reliable test for the common causes of fetal and maternal morbidity is needed. BDF previously developed an improved research-use-only test system for measuring NTproCNP for prediction of severe events in pregnancy very early before month 16. This marker is superior to all other solutions on the market, and to coming up solutions. However, before entering of NTproCNP measurement into medical routine, the marker has to be validated in a large prospective clinical study and NTproCNP measurement has to be made available in an automated and most robust way to guarantee worldwide application and distribution. Having this diagnostic tool in hand assuming 20,000 of severe cases in western countries could be prevented, saving lives and improving quality of life for women and families. Moreover, health care costs up to 1.3 billion Euro could be saved. The absolute market for the diagnostic tool is estimated to be nearly 290 million , promising as well high economic prospects and growth for BDF GmbH. In phase 1 of the project, information on potential clinical market in gynaecology as well as regulatory requirements in this segment will be collected and analysed, the clinical trial will be planned, and the elaborated business plan will be prepared.

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