SAVE UK Trial M-2016-313
Research type
Research Study
Full title
Proof-of-Concept Trial on Selective Removal of the Antiangiogenic Factor Soluble Fms-like Tyrosine Kinase-1 (sFlt-1) in Pregnant Women with Preeclampsia via Apheresis Utilizing the Flt-1 Adsorption Column (SAVE UK Trial)
IRAS ID
202397
Contact name
Manu Vatish
Contact email
Sponsor organisation
Miltenyi Biotec GmbH
Duration of Study in the UK
3 years, 4 months, 31 days
Research summary
This is a national, multi-centre, proof of concept trial on selective removal of a protein called sFIt-1 from the blood of pregnant women with pre-eclampsia with the aid of a specific filter, the sFlt-1 antibody adsorption column, in conjunction with the LIFE 18 apheresis unit. Abnormally high levels of sFIt-1 protein can be found in the blood of women with pre-eclampsia. This impairs the function of maternal blood vessels and is a possible cause of the disorder.
Apheresis is a well-known and frequently used procedure for the purification of the blood, similar to that used in kidney dialysis. The goal of this trial is to determine the safety of the apheresis procedure using the high affinity anti-sFlt-1 antibody adsorption column in conjunction with the LIFE 18 apheresis unit in healthy volunteers (Phase 0 of the trial) and patients with pre-eclampsia (Phases A and B of the trial). The study will ultimately establish whether sFlt-1 protein levels in the blood of patients with pre-eclampsia can be safely and effectively reduced by short-term apheresis, hopefully improving the conditions of both mother and child.
The overall goal of the apheresis treatment with TheraSorb-sFlt-1 absorber, to be tested in subsequent efficacy trial(s), is to prevent the progression of pre-eclampsia and to prolong the pregnancy compared to established clinical standards.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0200
Date of REC Opinion
5 Jul 2016
REC opinion
Further Information Favourable Opinion