The EVERREST consortium aims to carry out the first trial of a novel maternal growth factor gene therapy for severe early-onset FGR.
Read the article: Ethics and social acceptability of a proposed clinical trial using maternal gene therapy to treat severe early-onset fetal growth restriction
Published online 10 March 2016.
Comment from author, Dr Anna David
London, UK
'The lack of evidence-based treatments for many pregnancy complications is a major problem for pregnant women and their healthcare providers. Severe early-onset fetal growth restriction (FGR) is an example of such a complication. Currently, when a fetus is found to be very small in mid-pregnancy, there is no treatment to improve fetal growth in utero. In order to develop novel maternal and fetal therapies, clinical trials must be carried out that involve pregnant women, but this raises ethical and regulatory issues.'
'The EVERREST consortium aims to carry out the first trial of a novel maternal growth factor gene therapy for severe early-onset FGR. Encouraging data from preclinical studies suggest that increasing growth factor levels in the uteroplacental circulation using gene therapy could safely improve fetal growth. As this would potentially be the first use of gene therapy during pregnancy, the team investigated the ethical and social acceptability of giving gene therapy in a clinical trial to pregnant women. This was not only an important part of EVERREST’s work program but an opportunity to understand more about issues in the development of new pregnancy therapeutics.'
'The authors interviewed women who had experienced apregnancy affected by severe early-onset FGR. Most women viewed the proposed clinical trial positively and said that they would have wanted the option of participating in a trial. In particular, the women felt that they would have been capable of reaching an autonomous decision about whether to take part in a clinical trial, even at a very difficult time in their pregnancy. Clear information, independent advice and sufficient time for decision making were highlighted as important issues by women and stakeholders. Neither the literature review nor the interviews identified any fundamental objection to the use of gene therapy in pregnancy. This is very encouraging, not just for the EVERREST clinical trial, but also for the development of maternal and fetal therapies more broadly. The study provides a clear message for the clinical and pharmaceutical communities; that women want therapies for pregnancy diseases such as FGR, for which no treatment currently exists.'