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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).
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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 (9)

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UNIVERSITE CATHOLIQUE DE LOUVAIN

Belgium

EU Contribution

€ 1 364 915

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany

EU Contribution

€ 1 194 291,25

FMC BIOPOLYMER AS

Norway

EU Contribution

€ 236 861,25

NANOIMMUNOTECH SL

Spain

EU Contribution

€ 853 225

UNIVERSITE GRENOBLE ALPES

France

EU Contribution

€ 783 878,75

UNIVERSITE JOSEPH FOURIER GRENOBLE 1

France

ETABLISSEMENT FRANCAIS DU SANG

France

EU Contribution

€ 652 940

EUROPEAN RESEARCH SERVICES GMBH

Germany

EU Contribution

€ 159 275

WAKE FOREST UNIVERSITY HEALTH SCIENCES

United States

EU Contribution

€ 764 918,75

Project information

Grant agreement ID: 646272

Status

Ongoing project

  • Start date

    1 June 2015

  • End date

    30 September 2019

Funded under:

H2020-EU.2.1.3.1.

  • Overall budget:

    € 7 998 875

  • EU contribution

    € 7 998 875

Coordinated by:

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

France