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EF CLIF

European Foundation for the Study of Chronic Liver Failure
8 Projects, page 1 of 2
  • Funder: European Commission Project Code: 733057
    Overall Budget: 7,846,090 EURFunder Contribution: 6,478,740 EUR

    Liver disease incidence is increasing and about 170K patients die from liver failure each year in Europe. In liver failure, the accumulation of protein bound toxins and increased susceptibility to infection cause multiorgan failure and death. Liver transplantation is the only treatment known to prolong the life but is limited by availability of organs. A clinically efficacious ‘liver dialysis device’ is an unmet clinical need. The ALIVER Consortium has developed and optimised a novel ‘liver dialysis device’, DIALIVE. The DIALIVE device is protected by world-wide patents and is based upon our discovery that (i) albumin, a circulating protein involved in detoxification is reduced irreversibly in function and (ii) endotoxemia contributes to increased risk of infection in liver failure. DIALIVE incorporates albumin removal and replacement and, endotoxin removal and is a TRL5. In animal models of liver failure, DIALIVE was shown to be easy to use, safe, reduced endotoxemia and, improved albumin and immune function and, prolonged survival. The ALIVER Consortium, which is comprised of experts in liver failure, SMEs and charities proposes to perform clinical trials of DIALIVE in patients with acute on chronic liver failure (ACLF). During the grant period a CE-mark will be obtained and the device will progress to a TRL7/8. Consultation with Regulatory bodies confirms that if the trials are successful, a CE-mark is highly likely. Grifols, a large plasma proteins company is a potential licensee of the technology if the studies proposed by the ALIVER Consortium are positive. We plan to take the project through regulatory and ethics approval and perform a study to define its safety in ACLF patients in 18 European hospitals; define health economic benefits to the EU and define a reimbursement strategy. The results will be disseminated widely and results exploited to benefit patients, EU healthcare system, create new jobs and grow healthcare Industry in Europe.

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  • Funder: European Commission Project Code: 101080964
    Overall Budget: 6,530,110 EURFunder Contribution: 6,320,860 EUR

    Liver transplantation (LT) is a life-saving procedure for decompensated cirrhosis (DC) and hepato-cellular carcinoma (HCC). Its efficacy is hampered by the risk of death/drop-out on the Wait List (WL). This risk is driven by organ shortage and is mitigated by organ offering schemes. According to a sickest first policy, offering schemes prioritize LT candidates with the highest risk of dying, as assessed by predictive models. To drive allocation, Organ Sharing Organizations (OSOs) use a 20-year-old model, the MELD, predicting mortality in DC but not in HCC. Because of a dramatic increase in % of HCC candidates (40% against 10% in early 20ties), MELD schemes are increasingly inaccurate, with persisting 15 to 30% mortality in countries with low/medium donation rate. This scenario, together with advances in prognosis in DC and HCC candidates and statistics, prompts LT community to look for up-dated algorithms to refine offering schemes. To address this issue, key European LT stakeholders including OSOs, experts in LT, Statisticians, Research Labs and SME joined LEOPARD. Building on an innovative, harmonized OSOs pre-LT dataset and advances in modeling, LEOPARD propose to design and validate 1) an AI-based LEOPARD predictive algorithm outperforming current allocation models by better stratifying patients on the risk of mortality, to be proposed OSOs to drive allocation; 2) DC & HCC LEOPARD calculators available for professional for assistance in complex decision-making processes; 3) OMICs/radiomics predictive signatures integrated in a prototype 3rd-generation exploratory model. We expect to generate computational tools improving candidates’ outcomes, with more patients transplanted on time. Adoption of these tools should result in harmonization of European heterogeneous prioritization schemes, and in a signification reduction in disparities of access to LT, a major objective pointed out by EC. LEOPARD should place Europe in leading position for organ offering schemes.

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  • Funder: European Commission Project Code: 945096
    Overall Budget: 6,634,320 EURFunder Contribution: 6,000,000 EUR

    In Europe, about 30,000 people die every year from alcohol related cirrhosis, a form of chronic, non- communicable disease. The patients that are at highest risk of death are those with superimposed alcoholic hepatitis (AH) who do not respond to therapy and develop acute on chronic liver failure (ACLF), a newly described syndrome characterised by multiorgan failure. Treatment of ACLF is an unmet need. Based upon their clinical and pre-clinical studies, the A-TANGO consortium aims to perform Phase 2 clinical trials of a novel, patented and innovative therapeutic strategy by repurposing a toll-like 4 receptor antagonist (TAK242, Technology Readiness Level (TRL) 8), which targets inflammation, and combining it with granulocyte colony-stimulating factor (G-CSF, TRL9) that improves hepatocyte proliferation (G-TAK, TRL4). A successful trial will advance G-TAK to TRL8. Additionally, A-TANGO aims to discover novel biomarkers for patient selection and defining prognosis, building health economics models and reimbursement strategies to allow maximal dissemination and exploitation. The A-TANGO Consortium includes the inventors of G-TAK (UCL, Charité, ULEI and LUMC) and will deliver the project aims through EFCLIF, which has a network of 110 European hospitals. YAQ and HPX are SME’s that own the background IP and will ensure regulatory approval, study Sponsorship and drug supply. APHP and IMAC will deliver the economic models. Concentris will manage the project and together with EASL, CHX and ELPA will engage with patients, initiate widespread dissemination activities and allow exploitation of the results. Gender balance will be maintained throughout the project duration. A-TANGO will achieve the expected impacts of producing meaningful advances in clinical practice by reducing the mortality and improving the quality of life of patients with ACLF whilst reducing disease burden of individual patients and health care systems following validation in late stage clinical trials.

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  • Funder: European Commission Project Code: 964590
    Overall Budget: 1,999,370 EURFunder Contribution: 1,999,370 EUR

    Humans are microbial, living in close functional interaction with their skin and mucosal microbiomes. Human-microbes interplay has proven essential for the maintenance of health and well-being and profiling of microbiomes will become an essential feature of the personalized preventive nutrition and medicine of tomorrow. Europe has gained a leading position in microbiome science and yet to fulfill societal expectations, an international consensus will be essential on key aspects. These include i) clinical trial design as well as analytical standards, ii) definitions of healthy microbiomes as a function of numerous factors, accounting for confounders, iii) means of demonstrating causality of altered host-microbes interactions in diseases and iv) processes for the development of clinically relevant, validated biomarkers. The International Human Microbiome Concertation and Support Action (IHMCSA) will tackle all necessary steps to open the perspective of managing nutrition and health of the microbial human. Involving key stakeholders representing the multiplicity of actors concerned, including citizens, IHMCSA will map existing material, delineate necessary steps and pathways for innovation and build consensus on priorities and means for the future of microbiome science and its translation. This will lead to recommendations, validated by an international Strategic Steering Committee as well as academies of medicine of the world, directed to the European Commission, international research programmes, funding and regulatory agencies and decision makers of health systems. To ensure sustainability of the proposed measures, IHMCSA will promote unified repositories for sharing standards, SOPs and data, and contribute to the structuration of the European Microbiome Centers Consortium with a role in gathering world microbiome networks of excellence. With IHMCSA, human-associated microbiomes will be recognized for their true value in contributing to secure the future of mankind.

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  • Funder: European Commission Project Code: 634579
    Overall Budget: 9,579,690 EURFunder Contribution: 5,913,080 EUR

    Chronic liver disease affects about 29-million Europeans accounting for about 170,000 deaths at a cost of around €15.8bn. This chronic non-communicable disease is increasing at an alarming rate due to increasing European obesity, alcohol use and ageing. The three main causes of the disease; alcohol, fatty liver and viral hepatitis are amenable to prevention and treatment. Gut-derived endotoxins and bacterial translocation are central factors implicated in the pathogenesis of fatty liver disease and, the development and progression of cirrhosis. In cirrhosis, current state-of-the-art therapy to prevent recurrent complications of advanced cirrhosis is to use poorly absorbed antibiotics but long-term antibiotic therapy has problems associated with bacterial resistance, infection with resistant organisms and the cost. Treatment of fatty liver and modulation of bacterial translocation in early cirrhosis to prevent complications is an unmet need. Our academic-industrial consortium has developed a novel, patented, safe and cheap nanoporous carbon that modulates the effects of bacterial translocation in animal models of liver disease. Our feasibility studies demonstrate that this product advances the current state-of-the-art, is a TRL 4/5 and is now ready for validation through clinical trials. We propose to investigate the safety and efficacy of this novel nanoporous carbon in patients with fatty liver disease and cirrhosis. If successful, we will be able to confirm an innovative, cost-effective and novel strategy for the management of this chronic disease in a European population. Exploitation of the results of the CARBALIVE project will support the continued development of this carbon through additional private and public sector investment. The use of this innovative therapy is expected to reduce the economic burden of the disease in Europe, allow patients to achieve enhanced quality of life, improve survival, and allow many patients to return to economic productivity.

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