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Soft tissue engineering for congenital birth defects in children: new treatment modalities for spina bifida, urogenital and abdominal wall defects

Objective

The aim of this project is to use modern tissue engineering approaches to treat children with structural disorders present at birth, such as spina bifida, urogenital defects, gastroschisis, diaphragmatic hernia and esophageal atresia. The project strives to take a translational route through in vitro and animal experiments to early clinical trials. Tailor-made 'smart' biomatrices (scaffolds) will be prepared using natural scaffold molecules (collagen, elastin) and/or men-made polymers (poly lactic/glycolic acid), and will be substituted with regulatory molecules such as growth factors and glycosaminoglycans. A variety of cells, including stem cells, fibroblasts, muscle cells and urothelial/epithelial cells will be cultured in vitro and seeded into biomatrices. Biomatrices thus prepared, will be implanted using novel animal models for major congenital birth defects, and evaluated for their capacity to regenerate the correct tissues. Biomatrices will degrade in time and be replaced by the bodies own tissues thus assuring compliance with growth which is especially important in young children. Prenatal and postnatal reconstructive procedures will improve the final outcome of reconstructive surgery. Clinical trials for diaphragmatic hernias will form the start of the patient registry and protocol development for future clinical studies. Ethical and regulatory issues will be fully addressed before final clinical application, and parents and children will have to be able to understand these new treatment options. A dialogue with society, including patient's associations, will be sought. Demonstration activities will be undertaken to increase the awareness of new treatment modalities based on tissue-engineering. Finally, surgeons will be trained to use the new operation techniques. The project combines European leaders in the field of biomatrices, cell culture, animal models, surgery, and ethical and regulatory issues.

Coordinator

STICHTING KATHOLIEKE UNIVERSITEIT, MORE PARTICULARLY THE RADBOUD UNIVERSITY NIJMEGEN MEDICAL CENTRE

Address

Geert Grooteplein 9
9101 Nijmegen

Netherlands

Administrative Contact

Wouter FEITZ (Dr)

Participants (14)

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UPPSALA UNIVERSITY

Sweden

HOSPICES CANTONAUX CHUV

Switzerland

KATHOLIEKE UNIVERSITEIT LEUVEN

Belgium

KARL STORZ GMBH & CO.KG

Germany

UNIVERSITÄT ZURICH

Switzerland

MEDIZINISCHE UNIVERSITAET GRAZ (MEDICAL UNIVERSITY OF GRAZ)

Austria

CURATRIAL SMO & RESEARCH BV

Netherlands

EUROPEAN MEDICAL CONTRACT MANUFACTURING (E.M.C.M.) B.V.

Netherlands

SYMATESE BIOMATERIAUX

France

UNIVERSITY MEDICAL CENTRE GRONINGEN

Netherlands

INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER

Spain

THE FETAL MEDICINE FOUNDATION

United Kingdom

MATRICEL GMBH

Germany

ECOLE POLYTECHNIQUE FEDERALE DE LAUSANNE

Switzerland

Project information

Grant agreement ID: 37409

  • Start date

    1 January 2007

  • End date

    31 December 2011

Funded under:

FP6-LIFESCIHEALTH

  • Overall budget:

    € 8 668 500

  • EU contribution

    € 7 828 500

Coordinated by:

STICHTING KATHOLIEKE UNIVERSITEIT, MORE PARTICULARLY THE RADBOUD UNIVERSITY NIJMEGEN MEDICAL CENTRE

Netherlands