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Open Access Study protocol

Optimization of the viability of stem cells derived from umbilical cord blood after maternal supplementation with DHA during the second or third trimester of pregnancy: study protocol for a randomized controlled trial

Irene Martini1*, Enea Gino Di Domenico12, Roberta Scala3, Francesca Caruso1, Carla Ferreri4, Filippo M Ubaldi5, Andrea Lenzi6 and Herbert Valensise3

Author Affiliations

1 SmartBank, the stem cells bank, Rome, Italy

2 Istituto Pasteur-Fondazione Cenci Bolognetti, Department of Biology and Biotechnology “Charles Darwin”, Sapienza University of Rome, Rome, Italy

3 Department of Obstetrics and Gynaecology, Fatebenefratelli Isola Tiberina Hospital, Rome, Italy

4 ISOF, National Research Council, Bologna, Italy

5 GENERA, Centre for Reproductive Medicine, Clinica Valle Giulia, Rome, Italy

6 Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy

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Trials 2014, 15:164  doi:10.1186/1745-6215-15-164

Published: 10 May 2014

Abstract

Background

Umbilical cord blood (UCB) is an important source of hematopoietic stem cells (HSCs). However, the concentration of cells in cord blood units is limited and this may represent the main restriction to their therapeutic clinical use. The percentage of metabolically active stem cells provides a measure of the viability of cells in an UCB sample. It follows that an active cellular metabolism causes a proliferation in stem cells, offering an opportunity to increase the cellular concentration. A high cell dose is essential when transplanting cord stem cells, guaranteeing, in the receiving patient, a successful outcome.

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 UCB samples.

Methods/design

The metabolic demand of DHA increases in the course of pregnancy and reaches maximum absorption during the third trimester of pregnancy. According to these observations, this trial will be divided into two different experimental groups: in the first group, participants will be enrolled from the 20th week of estimated stage of gestation, before the maximum absorption of DHA; while in the second group, enrolment will start from the 28th week of estimated stage of gestation, when the DHA request is higher. Participants in the trial will be divided and randomly assigned to the placebo group or to the experimental group. Each participant will receive a complete set of capsules of either placebo (250 mg of olive oil) or DHA (250 mg), to take one a day from the 20th or from the 28th week, up to the 40th week of estimated gestational age. Samples of venous blood will be taken from all participants before taking placebo or DHA, at the 20th or at the 28th week, and at the 37th to 38th week of pregnancy to monitor the level of DHA. Cell number and cellular viability will be evaluated by flow cytometry within 48 hours of the UCB sample collection.

Trial registration

International Standard Randomised Controlled Trial Number Register: ISRCTN58396079. Registration date: 8 October 2013.