First maternal gene therapy trial to start at UCLH 

11/03/2016 00:00 
A pioneering trial of what is thought to be the first clinical use of gene therapy during pregnancy could be undertaken at UCLH, with the potential to save thousands of lives.

The trial took a step closer following the results of a study into the questions raised by gene therapy. The gene therapy would be given to mothers whose placenta is not providing sufficient nutrients and oxygen for their baby to grow.

This condition, called fetal growth restriction, is the most common cause of stillbirth. The study by the EVERREST consortium, a group including University College London and other institutions, found that there were no ethical or legal objections to maternal gene therapy.

Dr Anna David, UCLH consultant in obstetrics and maternal and fetal medicine, who is leading the consortium said: “The aim is to carry out the first trial of this therapy in pregnant women whose babies are most severely affected by fetal growth restriction (FGR) to test out its safety and efficacy.

“We hope the therapy will reduce stillbirths and neonatal deaths and improve neonatal and long term outcomes for affected babies.”

The consortium has been working since 2013 to develop a therapy for FGR which affects up to eight per cent of all pregnancies. Currently no treatment is available.
Once fetal growth restriction is identified in mid pregnancy, parents face a difficult  choice - delivering their baby very prematurely knowing that it might die, or allowing the pregnancy to continue with the strong likelihood that the baby will die in the womb.

Following the study results, Dr David said: “Almost all women viewed the proposed trial positively, and most felt that they would have wanted to participate. The views expressed by the women in our study echo the findings of other studies exploring women’s experiences of obstetric research. We must strive to develop therapies for pregnancy diseases such as fetal growth restriction, where no treatments currently exist.”

The research was funded by the European Commission and supported by the UCLH/UCL National Institute for Health Research Biomedical Research Centre.

If the trial is approved, it will start in early 2017 at University College Hospital and then be rolled out to other European centres.

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