LONDON, March 10 (UPI) -- Researchers found pregnant women are willing to participate in a trial for maternal gene therapy to treat early-onset fetal growth restriction, according to a study.
The researchers interviewed women and examined previous studies to inform ethical and legal concerns about EVERREST, a trial the researchers are considering mounting in Europe.
Fetal growth restriction is an incurable condition characterized by unnaturally slow growth of a fetus, caused by reduced blood flow typical of placental insufficiency. The condition affects about 8 percent of all pregnancies.
If EVERREST is approved, the researchers plan to treat pregnant women with the condition using a genetic drug causing increased production of vascular endothelial growth factor, or VEGF. The treatment has been shown in animals to improve fetal growth, according to a summary of the trial.
"Our study concluded that there were no ethical or legal objections to a trial of maternal gene therapy in pregnancy," said Dr. Richard Ashcroft, a professor of bioethics at Queen Mary University London, in a press release. "Women who had experienced pregnancies affected by fetal growth restriction were generally interested in participating in clinical trials which might potentially benefit their unborn child. The findings of our study are a major boost for the team's work on developing a treatment for fetal growth restriction which could save thousands of lives."
The researchers contacted 55 stakeholder groups, including midwifery and medical groups, parental support groups and others, 34 of which participated, and interviewed 24 women whose pregnancies were affected by the condition.
The stakeholders that responded also had a generally positive view, saying it is ethical to treat a pregnant woman for the benefit of the fetus but raised concerns about the psychological burden of the treatment, as well as the decision to participate. Nearly all the women interviewed viewed the trial positively, saying they were willing to accept the risk to themselves if a treatment could benefit their child.
Although researchers still need formal ethical and regulatory approval from the participating universities and the European Union, they hope to start the trial in early 2017 at facilities in England, Germany and Sweden.
"We hope that the therapy will reduce stillbirths and neonatal deaths, and improve neonatal and long term outcomes for affected babies," said Dr. Anna David, a researcher at University College London. "As this is potentially the first clinical use of gene therapy during pregnancy we were keen to establish responses to important ethical questions raised by the proposed trial."