Objective Fetal growth restriction (FGR) globally occurs in 8% of pregnancies, is severe and early onset in 1:500 cases, affecting 11,000 babies annually in the EU. In most cases, reduced uterine blood flow restricts substrate delivery to the fetus causing growth to slow or cease. There is no treatment. Currently the fetus is delivered very preterm before fetal death or irreversible organ damage occurs. Affected neonates suffer intracranial haemorrhage, chronic lung disease, cerebral palsy, with heart disease and diabetes as adults; mortality is high. Recent improvements in the care of premature growth restricted neonates, means that more of them survive delivery, but at great cost. Small increases in fetal growth and gestation at birth are associated with major improvements in survival and morbidity.Improving uterine blood flow is key and Vascular Endothelial Growth Factor (VEGF) is important to achieve this. In preclinical animal models we showed that local VEGF gene transfer to the uteroplacental circulation using adenovirus vectors increases uterine blood flow, attenuates constriction of uterine arteries and increases angiogenesis; these changes result in improved growth of severely growth restricted fetuses. This is the first clinically-applicable evidence based therapy that could improve perinatal outcome in severe early onset FGR in man.In collaboration with an SME experienced in gene therapy trials, our aim is to complete an agreed toxicology programme, identify specific ethical issues in stakeholders, and to perform a Phase I/II study in women with severe early onset FGR at four EU centres of excellence, using interventional radiology to deliver an adenovirus vector containing the mature processed form of human VEGF-D into the uterine artery. Data on safety, tolerability and efficacy will be analysed, and used, if successful, to inform phase II and III trials of this innovative therapy, leading to the first treatment for this intractable obstetric condition. Fields of science medical and health sciencesmedical biotechnologygenetic engineeringgene therapymedical and health sciencesclinical medicineendocrinologydiabetesmedical and health sciencesclinical medicineradiologymedical and health sciencesclinical medicineobstetricsfetal medicinemedical and health sciencesclinical medicineembryology Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2012.1.4-4 - Targeted nucleic acid delivery as an innovative therapeutic or prophylactic approach Call for proposal FP7-HEALTH-2012-INNOVATION-1 See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator UNIVERSITY COLLEGE LONDON EU contribution € 2 626 622,61 Address GOWER STREET WC1E 6BT London United Kingdom See on map Region London Inner London — West Camden and City of London Activity type Higher or Secondary Education Establishments Administrative Contact Greta Borg-Carbott (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (10) Sort alphabetically Sort by EU Contribution Expand all Collapse all TRIZELL LTD United Kingdom EU contribution € 1 383 155,16 Address SANDERUM HOUSE 38 OAKLEY ROAD 0X39 4TW CHINNOR OXFORDSHIRE See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Mark Docherty (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data QUEEN MARY UNIVERSITY OF LONDON United Kingdom EU contribution € 138 616,17 Address 327 MILE END ROAD E1 4NS London See on map Region London Inner London — East Tower Hamlets Activity type Higher or Secondary Education Establishments Administrative Contact Richard Edmund Ashcroft (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ITA-SUOMEN YLIOPISTO Finland EU contribution € 225 818,79 Address YLIOPISTONRANTA 8 70211 KUOPIO See on map Region Manner-Suomi Pohjois- ja Itä-Suomi Pohjois-Savo Activity type Higher or Secondary Education Establishments Administrative Contact Jaana Backman (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF Germany EU contribution € 244 559,94 Address Martinistrasse 52 20251 Hamburg See on map Region Hamburg Hamburg Hamburg Activity type Higher or Secondary Education Establishments Administrative Contact Kurt Hecher (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER Spain EU contribution € 357 780,40 Address CALLE ROSSELLO 149 PUERTA BJS 08036 Barcelona See on map Region Este Cataluña Barcelona Activity type Other Administrative Contact Pastora Martinez Samper (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data LUNDS UNIVERSITET Sweden EU contribution € 179 680,18 Address Paradisgatan 5c 22100 Lund See on map Region Södra Sverige Sydsverige Skåne län Activity type Higher or Secondary Education Establishments Administrative Contact Lena Gunnarsson (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data EURAM LIMITED Participation ended United Kingdom EU contribution € 259 139,85 Address LUCY TOWER STREET TOWER HOUSE LN1 1XW Lincoln See on map Region East Midlands (England) Lincolnshire Lincolnshire Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Andrew Banasik (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST United Kingdom EU contribution € 89 233,20 Address EUSTON ROAD 250 NW1 2PG London See on map Region London Inner London — West Camden and City of London Activity type Research Organisations Administrative Contact Joe Mwanza (Mr.) Links Contact the organisation Opens in new window Total cost No data MAGNUS INVENTION MANAGEMENT LTD Participation ended United Kingdom EU contribution € 413 185,70 Address GLASSLYN ROAD 39 N8 8RJ LONDON See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Gabrielle Robinson (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data INNVOTEK LTD United Kingdom EU contribution € 81 192,00 Address 43 BERKELE, SQUARE, MAYFAIR W1 5FJ LONDON See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Shahid Mughal (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data