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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-RTD
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Coordinator

UNIVERSITY COLLEGE LONDON
Address
Gower Street
WC1E 6BT London
United Kingdom
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 089 621,24

Participants (10)

YAQRIT LIMITED
United Kingdom
EU contribution
€ 2 821 450
Address
The Network Building 97 Tottenham Court Road
W1T 4TP London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
FAKKEL BVBA
Belgium
EU contribution
€ 1 158 750
Address
Pellenstraat 7
3400 Landen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF)
Spain
EU contribution
€ 120 500
Address
Travessera De Gracia 11, 7Th Floor
08021 Barcelona
Activity type
Research Organisations
ALBUTEC GMBH
Germany
EU contribution
€ 199 360,23
Address
Schillingallee 68
18057 Rostock
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUROPEAN ASSOCIATION FOR THE STUDYOF THE LIVER
Switzerland
EU contribution
€ 0
Address
Rue Daubin 7
1203 Geneve
Activity type
Other
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 46 515,30
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 227 963,61
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
UNIVERSITATSMEDIZIN ROSTOCK
Germany
EU contribution
€ 119 577,12
Address
Schillingallee 35
18055 Rostock
Activity type
Higher or Secondary Education Establishments
IBM IRELAND LIMITED
Ireland
EU contribution
€ 261 250
Address
Ibm House, Shelbourne Road
Dublin 4 Ballsbridge
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ROYAL FREE LONDON NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 433 750
Address
Pond Street Hampstead
NW3 2QG London
Activity type
Research Organisations