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Development of DIALIVE, a novel Liver Dialysis Device for the treatment of patients with Acute on Chronic Liver Failure (ACLF)

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.

Call for proposal

H2020-SC1-2016-2017

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Sub call

H2020-SC1-2016-RTD

Coordinator

UNIVERSITY COLLEGE LONDON
Net EU contribution
€ 1 089 621,24
Address
Gower Street
WC1E 6BT London
United Kingdom

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Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (11)

YAQRIT LIMITED
United Kingdom
Net EU contribution
€ 2 821 450,00
Address
The Elms Courtyard, Bromesberrow
HR8 1RZ Ledbury

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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)
Non-EU contribution
€ 1 059 500,00
FAKKEL BVBA
Belgium
Net EU contribution
€ 1 158 750,00
Address
Pellenstraat 7
3400 Landen

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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)
Non-EU contribution
€ 0,00
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

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Non-EU contribution
€ 0,00
ALBUTEC GMBH
Germany
Net EU contribution
€ 199 360,23
Address
Schillingallee 68
18057 Rostock

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Region
Mecklenburg-Vorpommern Mecklenburg-Vorpommern Rostock, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
EUROPEAN ASSOCIATION FOR THE STUDYOF THE LIVER
Switzerland
Net EU contribution
€ 0,00
Address
Rue Daubin 7
1203 Geneve

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Region
Schweiz/Suisse/Svizzera Région lémanique Genève
Activity type
Other
Non-EU contribution
€ 307 851,25
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
Net EU contribution
€ 46 515,30
Address
3 Avenue Victoria
75000 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
SERVICIO MADRILENO DE SALUD
Spain
Net EU contribution
€ 227 963,61
Address
Plaza Carlos Trias Bertran 7
28020 Madrid

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
UNIVERSITATSMEDIZIN ROSTOCK
Germany
Net EU contribution
€ 103 613,06
Address
Schillingallee 35
18055 Rostock

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Region
Mecklenburg-Vorpommern Mecklenburg-Vorpommern Rostock, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
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

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Research Organisations
Non-EU contribution
€ 0,00
IBM IRELAND LIMITED
Ireland
Net EU contribution
€ 261 250,00
Address
Ibm House, Shelbourne Road
Dublin 4 Ballsbridge

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Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ROYAL FREE LONDON NHS FOUNDATION TRUST
United Kingdom
Net EU contribution
€ 433 750,00
Address
Pond Street Hampstead
NW3 2QG London

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Region
London Inner London — West Camden and City of London
Activity type
Research Organisations
Non-EU contribution
€ 0,00