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Tissue engineering of the right heart outflow tract by a biofunctionalized bioresorbable polymeric valved tube

Objective

Approximately 42% of infants’ mortality in the world is related to congenital heart defects (prevalence: 8-12/1000 births). Over 1/3 require the reconstruction of the right ventricular outflow tract (RVOT) by surgical procedures which currently use inert materials without any growth potential. Consequently, multiple reoperations are often required, with their attendant high risk of mortality and morbidity.
The TEH-TUBE project will address these limitations by creating a novel bioabsorbable biomaterial using a polymeric valved tube either seeded with autologous adipose tissue derived stem cells (ADSC) or functionalized by a peptidic sequence triggering homing of the host cells onto the scaffold to make it a living self-populated structure. During the project we will:
• Compare a number of polymers, including but not limited to polydioxanone, polyhydroxyalkanoate, and poly-ester-urethane-ureas, processed by electrospinning to generate a competent valved tube
• Compare, in the selected polymer, different methods of functionalisation using in vitro mechanical and biological tests as well as in vivo animal experiments (primarily rats)
• Validate the ultimate combination (polymer + functionalisation technique) in a clinically relevant large animal model (in this case, the growing lamb to specifically assess the regenerative and growth potential of the composite construct)
This stepwise approach will be conducted within a tightly controlled regulatory framework to ensure that the final product meets the current ATMP requirements for phase I/II clinical studies and, if successful, ultimate commercialization.
Our TEH-TUBE project aims at developing an innovative biomaterial for the treatment of congenital heart abnormalities in children and young adults. By creating a material whose growth will keep pace with that of the patient, this product, geared to become an ATMP, should decrease the risk of reoperative surgeries, improve the quality of life and ultimately have a positive impact on healthcare costs.

Call for proposal

FP7-NMP-2013-SME-7
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Coordinator

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
Address
3 Avenue Victoria
75000 Paris
France

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Activity type
Research Organisations
Administrative Contact
Estelle Ziegler (Mrs.)
EU contribution
€ 765 880

Participants (6)

STATICE SAS
France
EU contribution
€ 794 902
Address
Rue Thomas Edison 9
25000 Besancon

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Anne Legain (Ms.)
RESCOLL
France
EU contribution
€ 676 860
Address
Allee Geoffroy Saint Hilaire 8 Cs 30021
33600 Pessac

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Konstantin Sipos (Mr.)
CELYAD
Belgium
EU contribution
€ 893 060
Address
Rue Edouard Belin 12
1435 Mont Saint Guibert

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Aymeric Seron (Mr.)
UCL Elizabeth Garrett Anderson Institute for Women’s Health
United Kingdom
EU contribution
€ 368 466
Address
Gower Street
WC1E 6BT London

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kamila Kolasinska (Ms.)
HELMHOLTZ-ZENTRUM HEREON GMBH
Germany
EU contribution
€ 748 034
Address
Max Planck Strasse 1
21502 Geesthacht

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Activity type
Research Organisations
Administrative Contact
Hans-Jörg Isemer (Dr.)
EURAM LIMITED
United Kingdom
EU contribution
€ 253 760
Address
Lucy Tower Street Tower House
LN1 1XW Lincoln

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Andrew Banasik (Mr.)