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The Objectives

The aim of the project is to carry out the first trial of maternal growth factor therapy in pregnant women affected by severe early onset fetal growth restriction (FGR). Our previous research has shown that gene therapy with Vascular Endothelial Growth Factor (VEGF) can improve fetal growth in pregnancies affected by FGR. This will be a Phase I/IIa trial as it will be looking at the safety of the treatment and whether it works.

The project will last for 6 years.

During the first phase of the project (2.5 years):

  1. Reproductive toxicology experiments will be carried out to check for any safety issues, in particular, whether the viral vector is toxic and whether it crosses the placenta to the baby.

  2. Using gene therapy in pregnancy also raises ethical questions. To address these a bioethicist will be carrying out research into the ethical issues and public opinion around maternal gene therapy in pregnancy.

  3. At the four clinical centres data on outcome of pregnancies affected by severe early onset fetal growth restriction will be carefully collected into a prospective database so that it can be used to compare outcomes with treated pregnancies in the trial. The clinical trial protocol will also be designed.

  4. The Consortium will then apply for ethical and regulatory approval to do the trial at the four clinical centres.

  5. Women with pregnancies affected by severe early onset fetal growth restriction being managed in the four project centers will be given the opportunity to enter the phase I/IIa study.

  6. We will present the results of the study findings widely in the EU and US and begin to develop the next phase of translating this therapy into the clinic.

  7. The administrative and financial management of the project are being carried out by a company called EURAM.