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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-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
Address
Rue Leblanc 25
75015 Paris 15
France
Activity type
Research Organisations
EU contribution
€ 1 988 570

Participants (8)

UNIVERSITE CATHOLIQUE DE LOUVAIN
Belgium
EU contribution
€ 1 364 915
Address
Place De L Universite 1
1348 Louvain La Neuve
Activity type
Higher or Secondary Education Establishments
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 1 194 291,25
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
FMC BIOPOLYMER AS
Norway
EU contribution
€ 236 861,25
Address
Industriveien 33
1337 Sandvika
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
NANOIMMUNOTECH SL
Spain
EU contribution
€ 853 225
Address
Edificio Citexvi C Fonte Das Abelle Sn Campus Universitario De Vigo
36310 Vigo Pontevedra
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITE GRENOBLE ALPES
France
EU contribution
€ 783 878,75
Address
621 Avenue Centrale
38058 Grenoble
Activity type
Higher or Secondary Education Establishments
ETABLISSEMENT FRANCAIS DU SANG
France
EU contribution
€ 652 940
Address
Avenue Du Stade De France 20
93210 La Plaine Saint Denis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
EUROPEAN RESEARCH SERVICES GMBH
Germany
EU contribution
€ 159 275
Address
Roentgenstrasse 19
48149 Muenster
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
WAKE FOREST UNIVERSITY HEALTH SCIENCES
United States
EU contribution
€ 764 918,75
Address
Medical Center Boulevard
27157 Winston Salem Nc
Activity type
Higher or Secondary Education Establishments