EVERREST Project - Clinical Trial

Scientific title: Does maternal growth factor gene therapy safely improve outcome in severe placental insufficiency?

An open label, dose-escalating phase I/II trial to determine the safety and efficacy of intra-uterine artery administration of Ad.VEGF-D^DNDC in women with pregnancies affected by severe early-onset placental insufficiency

The EVERREST Clinical Trial is currently in the set-up phase. It is a gene-therapy, first-in-man trial looking to develop an effective treatment for pregnant women diagnosed with severe early onset placental insufficiency.

The main aim of the EVERREST Clinical Trial is to see if using a replication deficient adenoviral vector expressing vascular endothelial growth factor (VEGF) can be used safely in pregnant women to treat severe early onset placental insufficiency. Some of the key secondary outcomes for trial are: increased uterine artery volume blood flow, fetal, neonatal and infant growth, andthe experience and psychological impact of trial participation.

The trial will investigate the maximum tolerated dose of the ATIMP using a 3 + 3 expansion dose escalation design. Up to 27 women will be recruited to the EVERREST Clinical Trial, the criteria to define the trial sample population is based on the data already collected as part of the EVERREST prospective study.

Funder: European Commission

Sponsor: University College London