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BIOactive implantable CApsule for PANcreatic islets immunosuppression free therapy

Objective

The key therapeutic issue in diabetes mellitus type I and II is glycaemic control. Reductions of constant self-control, of insulin injections, and of long-term complications would have tremendous benefit for quality of life. The best therapy option is the transplantation of allogeneic islet cells, but the current state of the art limits the applicability of this approach. Implanting unprotected grafts requires lifelong administration of immunosuppressants, and protecting the cells against adverse immune reactions by current encapsulation strategies reduces their functionality and survival to an extend that makes frequent ‘refresher’ implantations necessary. Currently, a maximum of 2 years glycaemia regulation has been shown for the encapsulated approach.

In BIOCAPAN, bringing experts from different fields all together, we aim at developing an innovative treatment, based on the implantation of allogeneic islet cells that are embedded in a complex microcapsule. We will design a GMP-grade bioactive microcapsule that will maximize the long-term functionality and survival of pancreatic islets by prevention of pericapsular fibrotic overgrowth, in situ oxygenation, innovative extracellular matrix microenvironment reconstruction and immune-system modulation. We will establish a GMP-grade microfluidic microencapsulation platform to protect freshly harvested islets quickly in a standardized and reproducible way.

We aim for full preclinical validation and we will establish a complete protocol in accordance with the provisions of the Advanced Therapy Medicinal Products Regulation, in order to start clinical trials within one year after the end of the project. We aim for 5-years insulin injection free treatment, without immunosuppressants, which would tremendously benefit diabetes mellitus patients who require insulin (all Type I and about one in six Type II Diabetes Mellitus patients).

Call for proposal

H2020-NMP-2014-2015

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Sub call

H2020-NMP-2014-two-stage

Coordinator

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
Net EU contribution
€ 1 988 570,00
Address
Rue Leblanc 25
75015 Paris 15
France

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 0,00

Participants (9)

UNIVERSITE CATHOLIQUE DE LOUVAIN
Belgium
Net EU contribution
€ 1 364 915,00
Address
Place De L Universite 1
1348 Louvain La Neuve

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Region
Région wallonne Prov. Brabant Wallon Arr. Nivelles
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
Net EU contribution
€ 1 194 291,25
Address
Chariteplatz 1
10117 Berlin

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Region
Berlin Berlin Berlin
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
FMC BIOPOLYMER AS
Norway
Net EU contribution
€ 236 861,25
Address
Industriveien 33
1337 Sandvika

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Region
Norge Oslo og Viken Viken
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
NANOIMMUNOTECH SL
Spain
Net EU contribution
€ 853 225,00
Address
Edificio Citexvi C Fonte Das Abelle Sn Campus Universitario De Vigo
36310 Vigo Pontevedra

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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
Noroeste Galicia Pontevedra
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
UNIVERSITE GRENOBLE ALPES
France
Net EU contribution
€ 721 378,75
Address
621 Avenue Centrale
38058 Grenoble

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Region
Auvergne-Rhône-Alpes Rhône-Alpes Isère
Activity type
Higher or Secondary Education Establishments
Other funding
€ 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.

CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE
France
Net EU contribution
€ 62 500,00
Address
Boulevard De La Chantourne
38700 La Tronche

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Region
Auvergne-Rhône-Alpes Rhône-Alpes Isère
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
ETABLISSEMENT FRANCAIS DU SANG
France
Net EU contribution
€ 652 940,00
Address
Avenue Du Stade De France 20
93210 La Plaine Saint Denis

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Region
Ile-de-France Ile-de-France Seine-Saint-Denis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
EUROPEAN RESEARCH SERVICES GMBH
Germany
Net EU contribution
€ 159 275,00
Address
Huefferstr. 5
48149 Muenster

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Region
Nordrhein-Westfalen Münster Münster, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
WAKE FOREST UNIVERSITY HEALTH SCIENCES
United States
Net EU contribution
€ 764 918,75
Address
Medical Center Boulevard
27157 Winston Salem Nc

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Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00