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Work Package - 5

Phase I/II Clinical Study

An uncontrolled open-label, dose finding safety, tolerability and efficacy Phase I/II study in pregnancies affected by severe early onset FGR.

Objectives:

  1. To determine the safety and tolerability to mother and fetus of uterine artery catheterisation, transient (2 minute) uterine artery occlusion and injection of Ad.VEGF-D in pregnancies complicated by severe early onset FGR.

  2. To measure efficacy by 1) improved uterine blood flow 2) restoring fetal growth and increasing gestational age at delivery, and 3) reducing a composite outcome for fetal and neonatal mortality and serious morbidity from 80% to 60%, when compared to historical data from untreated pregnancies affected by severe early onset FGR.

  3. To study the mechanism of action by assessing changes in placental phenotype and myometrial arteries (VEGF expression, angiogenesis and vascular reactivity) after Ad.VEGF-D gene transfer to the uterine arteries in pregnancies affected by severe early onset FGR.

A data safety monitoring board will report on the safety and conduct of the trial.