A randomised controlled trial for the optimization of the viability of stem cells derived from umbilical CORd blood after maternal ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2010-2014

ABSTRACT

Background and study aims The umbilical cord blood is an important source of hematopoietic stem cells (the blood cells that give rise to all the other blood cells). However, the amount of cells in the cord blood units is limited and this may restrict their clinical use. The cell viability (ability of the cell to survive) of an umbilical cord blood sample measures the percentage of the metabolic active stem cells. It follows that an active cellular metabolism causes increased production of stem cells, offering an opportunity to increase the number of cells. A high cell dose is essential when transplanting cord stem cells, guaranteeing a successful outcome in the receiving person. This study is designed to evaluate the impact of docosahexaenoic acid (DHA) supplementation in pregnant women, in order to increase the quantity and viability of the cells in the umbilical cord blood samples. Who can participate? Women aged >18 years and absence of: diabetes, high blood pressure (hypertension) or any other type of health problems requiring intake of medicines, genetic diseases, chromosome abnormalities and/or congenital malformations in the foetus and the absence of infectious disease (hepatitis B, hepatitis C, HIV and cytomegalovirus). What does the study involve? Participants are randomly allocated to receive either placebo (dummy) or DHA (250 mg) one a day from the 20th week or DHA (250 mg) one a day from the 28th week up to the 40th week. Cell number and cellular viability are evaluated within 48 hours of the collection of the umbilical cord blood sample. What are the possible benefits and risks of participating? Participants receiving DHA may benefit from an increased amount of stem cells being collected in the umbilical cord blood samples at birth. At the moment there are no risks related to the use of DHA during pregnancy. Where is the study run from? The study has been set up by the SmartBank in collaboration with San Giovanni Calibita FatebeneFratelli-Roma hospital. 62 pregnant women will be recruited from those using the Gynaecological and Obstetrics Service of the San Giovanni Calibita FatebeneFratelli-Roma hospital, and 88 will be selected from the SmartBank’s clients. When is the study starting and how long is it expected to run for? The recruitment started in 2010 and participants will be enrolled on the study for a period of four years. Who is funding the study? This study is supported by SmartBank s.r.l., BioVault Ltd and Avantgarde s.a.s Who is the main contact? Dr Irene Martini Dr Enea Gino Di Domenico, enea.didomenico@uniroma1.it More... »

URL

http://www.isrctn.com/ISRCTN58396079

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