EVERREST - Does vascular endothelial growth factor gene therapy safely improve outcome in severe early-onset fetal growth restriction?

Fetal Growth Restriction (FGR) is an important condition which affects 8 out of 100 pregnancies and means that the baby does not grow in the womb as well as it should. At the moment there is no treatment. There is also no way to predict and prevent fetal growth restriction from occurring. Sadly some babies die in the womb and others have to be delivered prematurely. Babies who are small and premature can have serious health problems immediately after birth and as they grow; some babies may even die after birth.

The EVERREST project is aiming to develop a treatment for fetal growth restriction. The most common cause is a lack of sufficient blood flowing to the womb via the mother’s circulation. This results in a lack of nutrients and oxygen to the developing baby. Our previous research has shown that increasing blood flow to the womb using localized maternal VEGF gene therapy can improve fetal growth. The aim of the project is to carry out the first trial of this therapy in pregnant women whose babies are most severely affected by fetal growth restriction to test out its safety and efficacy. Potential benefits from the research could include reduced stillbirths and neonatal deaths, and improved neonatal and long term outcomes in pregnancies affected by severe early onset fetal growth restriction.

Main Goals:

Objectives:The EVERREST project is testing out a new treatment to improve the growth of babies with fetal growth restriction in the womb. An injection will be given into the two mother’s arteries which supply the womb with blood. This injection will contain a form of gene therapy to make the mother’s arteries produce more of a protein called VEGF. This protein will increase the blood supply to the womb and placenta and improve growth of the baby in the womb.
This would mean that affected babies could be delivered later and would weigh more, giving them a better chance of survival after birth and improving their outcome. What is most promising is that relatively small increases in growth of the baby and gestational age at delivery are associated with major improvements in survival and morbidity. For example, as each day of pregnancy advances between 24 and 27 weeks of gestation, there is a 2% improvement in survival after birth. Between 23 and 26 weeks of gestation, an increase in birthweight of 100g reduces the risk of dying by 40%.

Work Packages:

Page 13-34 Technical Annex 1

List of participants:

Participant no.Participant legal name (short name)Country
1 (Co-ordinator)University College London (UCL)UK
2Ark Therapeutics Group Plc, London (ARK)UK
3Queen Mary and Westfield College, University of London (QMUL)UK
4Itä-Suomenyliopisto (UEF)FI
5Universitätsklinikum Hamburg – Eppendorf (UKE)DE
6Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS)ES
7Lunds Universitet (ULUND)SE
8Euram Limited (EURAM)UK

Webpage: http://everrest-fp7.eu
Official project number:CE_FP7_HEALTH_IN1_12_305823
Funding agency: European Commission

Start Date: 01/01/2013
End Date: 31/12/2018

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Last update: 20-Nov-2019 3:42 pm