BIOSID

A bioartificial pancreas to treat type 1 diabetes: optimization of cell survival and function in preclinical and clinical phases

 Coordinatore CENTRE EUROPEEN D'ETUDE DU DIABETE 

 Organization address address: BOULEVARD RENE LERICHE
city: STRASBOURG
postcode: 67200

contact info
Titolo: Dr.
Nome: Severine
Cognome: Sigrist
Email: send email
Telefono: +33 3 90201030

 Nazionalità Coordinatore France [FR]
 Sito del progetto http://www.biosid-eu.org
 Totale costo 7˙191˙764 €
 EC contributo 5˙469˙603 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2012-INNOVATION-1
 Funding Scheme CP-FP
 Anno di inizio 2013
 Periodo (anno-mese-giorno) 2013-01-01   -   2015-12-31

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    CENTRE EUROPEEN D'ETUDE DU DIABETE

 Organization address address: BOULEVARD RENE LERICHE
city: STRASBOURG
postcode: 67200

contact info
Titolo: Dr.
Nome: Severine
Cognome: Sigrist
Email: send email
Telefono: +33 3 90201030

FR (STRASBOURG) coordinator 812˙317.60
2    UNIVERSITE CATHOLIQUE DE LOUVAIN

 Organization address address: Place De L'Universite 1
city: LOUVAIN LA NEUVE
postcode: 1348

contact info
Titolo: Prof.
Nome: Pierre
Cognome: Gianello
Email: send email
Telefono: +32 2 7645586
Fax: +32 2 7645589

BE (LOUVAIN LA NEUVE) participant 1˙152˙398.00
3    THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

 Organization address address: University Offices, Wellington Square
city: OXFORD
postcode: OX1 2JD

contact info
Titolo: Ms.
Nome: Linda
Cognome: Pialek
Email: send email
Telefono: +44 1865 289800
Fax: +44 1865 289801

UK (OXFORD) participant 1˙114˙032.00
4    CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER

 Organization address address: Avenue du Doyen Gaston Giraud 191
city: MONTPELLIER
postcode: 34295

contact info
Titolo: Mrs.
Nome: Valérie
Cognome: Handweiler
Email: send email
Telefono: 33467339643
Fax: 33467330864

FR (MONTPELLIER) participant 735˙574.00
5    DEFYMED SAS

 Organization address address: BOULEVARD RENE LERICHE
city: STRASBOURG
postcode: 67200

contact info
Titolo: Dr.
Nome: Richard
Cognome: Bou Aoun
Email: send email
Telefono: 33390410279
Fax: 33390201219

FR (STRASBOURG) participant 606˙800.00
6    SARL ENDOCELLS

 Organization address address: Boulevard Saint Germain 216
city: Paris
postcode: 75007

contact info
Titolo: Dr.
Nome: Anne-Fabienne
Cognome: Weitsch
Email: send email
Telefono: 33610680433

FR (Paris) participant 585˙200.00
7    AvantiCell Science Ltd

 Organization address address: GIBBSYARD BUILDING
city: AYR
postcode: KA6 5HW

contact info
Titolo: Dr.
Nome: Colin
Cognome: Wilde
Email: send email
Telefono: 441293000000
Fax: 441293000000

UK (AYR) participant 463˙281.60

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

biosid    project    islets    mailpan    models    transplantation    encapsulation    safety    pre    immunosuppressive    diabetes    life    clinical    human    membranes    function    device    pancreas    macroencapsulation    mechanisms    biocompatibility    hypoxia    commercialisation    bioartificial    isolation    culture    industry    cells    cell    faster    insulin    promising    molecules    optimising    defymed    affecting    rejection    gathered    islet    glucose    prototype    therapy    survival    pancreatic    medium   

 Obiettivo del progetto (Objective)

'MAILPAN (MAcroencapsulation of PANcreatic Islets) is a prototype of bioartificial pancreas usable in the human designed to treat type 1 diabetic patients. The prototype was developed along different stages since 1996 and led to the creation of the SME called Defymed in 2011. Next step is now to bring the prototype to the pre-clinical and clinical phases necessary to the ensuing commercialization of MAILPAN whose ultimate goal is to improve the life of at least 20 million persons in the world while providing positive effects on healthcare management and expenses, the environment and the competitiveness of the biomaterials industry.

In order to reach this goal, CeeD and Defymed gathered a consortium made of seven partners from academia, clinical/public health research sector and industry/SMEs from three different European countries –Belgium, France and UK. The expertise gathered include encapsulation techniques, islet isolation, cell engineering, islet transplantation, islet preconditioning, surgical implantation, and medium formulation; items that are complementary and necessary to the implementation of the present project proposal.

The project proposal of a 36-month duration intends to bring the most modern and up to date improvements that the bioartificial pancreas still needs and can receive such as to enhance cells survival inside the device by formulating a new adapted cell culture medium, to further lower the rejection risk by studying the biocompatibility and anti-inflammatory mechanisms, to test the prototype in primates, and to validate its further use in humans. Safety, bio-compatibility and interoperability of MAILPAN device combined to the islets/pseudo-islets, will be assessed, in respect to the applied regulatory directives.'

Descrizione progetto (Article)

Diabetes management currently involves a modified diet and lifestyle as well as insulin therapy or pancreas/islets transplantation. Insulin therapy requires constant glucose monitoring, and issues with transplantation include use of immunosuppressive drugs, donor incompatibility, organ shortage and rejection.

Macroencapsulation of pancreatic islets (MAILPAN) is a prototype of a bioartificial pancreas device that uses encapsulation with artificial membranes to ensure effective immune isolation of insulin-secreting cells. Selective permeability in the membranes will obviate the need for immunosuppressive therapy.

The http://biosid-eu.org/ (BIOSID) project is optimising MAILPAN for pre-clinical and clinical testing. The goal is to facilitate rapid commercialisation of this technology after ensuring safety, biocompatibility and efficacy. For this purpose, they focused on minimising rejection of transplanted islets of Langerhans cells while maximising their function. They also worked on optimising properties of the MAILPAN membrane.

Within the first 18 months of the project period itself, BIOSID elucidated the physical-chemical conditions and mechanisms affecting islet survival and function. Major factors adversely affecting islet survival and function in MAILPAN were found to be islet cell confinement and hypoxia. Hypoxia is a condition where oxygen levels are inadequate.

Project findings paved the way for the development of a high-throughput platform to identify promising molecules and molecule combinations that can effectively counteract adverse conditions. The shortlisted molecules can then be utilised in cell culture medium to optimise cell viability and function in MAILPAN. EndoC-betaH1 are stable insulin-producing glucose-responsive cells that have successfully rescued mice with chemically induced diabetes. These cells were selected for transplantation in the device prototype.

Researchers also demonstrated the safety and biocompatibility of MAILPAN in small and large animal models. However, testing is ongoing using different cell types and cell origins for further optimisation. Such promising data should aid in obtaining approvals for human clinical trials.

Project activities were disseminated via the website, several international meetings, over 20 press media and 7 congresses.

Successful outcomes in tests on primate models will ensure faster authorisation of the optimised MAILPAN device for human clinical studies. Ultimately, faster commercialisation should improve the prognosis and quality of life for millions of diabetics.

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