Project description DEENESFRITPL A novel liver dialysis device Liver failure leads to the accumulation of toxins and increases the patient's vulnerability to infection, ultimately resulting in multi-organ failure and premature death. While liver transplantation is the only method to extend life, its effectiveness is hindered by organ scarcity and high healthcare costs. To address this unmet clinical need, scientists of the EU-funded ALIVER project have developed a novel liver dialysis device called DIALIVE. Preclinical testing of the device shows promising results with improved albumin function and reduced endotoxins. The ALIVER project will conduct clinical trials of DIALIVE in patients with acute or chronic liver failure towards obtaining CE marking for future clinical use. Show the project objective Hide the project objective Objective 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. Fields of science natural sciencesbiological sciencesbiochemistrybiomoleculesproteinsmedical and health sciencesclinical medicinehepatologymedical and health sciencesclinical medicinetransplantation Keywords liver failure liver dialysis liver transplantation hepatic encephalopathy hepatorenal syndrome extracorporeal assist Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SC1-PM-09-2016 - New therapies for chronic diseases Call for proposal H2020-SC1-2016-2017 See other projects for this call Sub call H2020-SC1-2016-RTD Funding Scheme RIA - Research and Innovation action Coordinator UNIVERSITY COLLEGE LONDON Net EU contribution € 1 089 621,24 Address GOWER STREET WC1E 6BT London United Kingdom See on map Region London Inner London — West Camden and City of London Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 089 621,24 Participants (11) Sort alphabetically Sort by Net EU contribution Expand all Collapse all YAQRIT LIMITED United Kingdom Net EU contribution € 2 821 450,00 Address THE ELMS COURTYARD, BROMESBERROW HR8 1RZ Ledbury See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Gloucestershire Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 3 880 950,00 FAKKEL BVBA Belgium Net EU contribution € 1 158 750,00 Address PELLENSTRAAT 7 3400 Landen See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 158 750,00 EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF) Spain Net EU contribution € 120 500,00 Address TRAVESSERA DE GRACIA 11, 7TH FLOOR 08021 Barcelona See on map Region Este Cataluña Barcelona Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 120 500,00 ALBUTEC GMBH Germany Net EU contribution € 199 360,23 Address SCHILLINGALLEE 68 18057 Rostock See on map Region Mecklenburg-Vorpommern Mecklenburg-Vorpommern Rostock, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 199 360,23 EUROPEAN ASSOCIATION FOR THE STUDYOF THE LIVER Switzerland Net EU contribution € 0,00 Address RUE DAUBIN 7 1203 Geneve See on map Region Schweiz/Suisse/Svizzera Région lémanique Genève Activity type Other Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 307 851,25 ASSISTANCE PUBLIQUE HOPITAUX DE PARIS France Net EU contribution € 46 515,30 Address 55 BOULEVARD DIDEROT 75012 Paris See on map Region Ile-de-France Ile-de-France Val-de-Marne Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 46 515,30 SERVICIO MADRILENO DE SALUD Spain Net EU contribution € 227 963,61 Address Paseo De la Castellana, 280 28046 MADRID See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 227 963,61 UNIVERSITATSMEDIZIN ROSTOCK Germany Net EU contribution € 103 613,06 Address SCHILLINGALLEE 35 18055 Rostock See on map Region Mecklenburg-Vorpommern Mecklenburg-Vorpommern Rostock, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 119 577,12 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV Germany Net EU contribution € 15 964,06 Address HANSASTRASSE 27C 80686 Munchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 15 964,06 IBM IRELAND LIMITED Ireland Net EU contribution € 261 250,00 Address BD 2 IBM TECHNOLOGY CAMPUS DAMASTOWN INDUSTRIAL PA MULHUDDART D15 HN66 DUBLIN See on map Region Ireland Eastern and Midland Dublin Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 261 250,00 ROYAL FREE LONDON NHS FOUNDATION TRUST United Kingdom Net EU contribution € 433 750,00 Address POND STREET HAMPSTEAD NW3 2QG London See on map Region London Inner London — West Camden and City of London Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 433 750,00