Identification and characterisation of circulating foetal cells
Research type
Research Study
Full title
Development and optimisation of a protocol that can identify and characterise circulating foetal cells from maternal blood using a microfluidic cell separation system
IRAS ID
170127
Contact name
Kyra Archibald
Contact email
Sponsor organisation
ANGLE plc
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The most common techniques to obtain foetal tissue for prenatal diagnosis of genetic abnormalities and other health indicators are amniocentesis and chorionic villus sampling. These are invasive techniques in which a sample of amniotic fluid or placenta tissue containing foetal cells is biopsied using a fine needle. These procedures involve an increased risk of miscarriage estimated to be around 1 in 100. Consequently, these tests are only offered to high risks patients after a first trimester screening test.
Parsortix Limited (part of the Angle plc group of companies) is developing an alternative; that of of capturing and analysing foetal cells that circulate in the mother’s blood stream. This would be achieved through a small blood sample without compromising the health of mother and baby. We will use the Parsorter cell separation system, an instrument the company has developed to enable isolation of rare cells from blood samples. The system is able to capture foetal cells enabling a range of analysis techniques, namely immunostaining, fluorescence in situ hybridisation and DNA and RNA analysis. This method would not only be useful as a diagnostic test for Down’s syndrome and other trisomies but could provide insight into additional biomarkers of foetal health.
The aim of this study is to optimise the cell separation process and establish the procedures for cell analysis. We will require the participation of a maximum of 100 healthy pregnant volunteers to donate small blood samples (up to 20 ml). Additionally, we will recruit up to 100 healthy non-pregnant donors for control purposes. Blood samples will be anonymised and the volunteers will not have further interaction with the research project after the sample is collected. All personal data will be kept confidential. Blood, cells and DNA will only be used for this specific study. The project is expected to last 3 years.REC name
East of Scotland Research Ethics Service REC 2
REC reference
15/ES/0024
Date of REC Opinion
24 Feb 2015
REC opinion
Further Information Favourable Opinion