Condition category
Pregnancy and Childbirth
Date applied
18/09/2013
Date assigned
08/10/2013
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Irene Martini

ORCID ID

Contact details

Via Vittorio Locchi
9
Rome
00197
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial for the 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

Acronym

CORDHA

Study hypothesis

This study is designed to evaluate the impact of the DHA supplementation in pregnant women during the second (20th week of estimated gestational stage) or the third (28th week of estimated gestational stage) trimester of pregnancy, in order to increase the quantity and viability of the cells, in particular of the haematopoietic lineage, in the umbilical cord blood samples collected at birth.

Ethics approval

Ethical Committee of the FateBeneFratelli San Giovanni Calibita Hospital - Isola Tiberina, 09/07/2009, ref: 35/2009; and 09/12/2010, ref: 67/2010

Study design

Four years randomised double blind monocentric study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Increase the quantity and viability of the stem cells, in the umbilical cord blood samples in pregnant women supplemented with DHA.

Intervention

150 pregnant women will be recruited from the Gynaecological and Obstetrics Service of the 
San Giovanni Calibita FatebeneFratelli-Roma hospital, and from the SmartBank’s clients. 
Each participant receives 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.

The DHA capsules (active batch) contain 250 mg IncromegaTM DHA 250TG SR+10 mg natural VIT E (Avantgarde sigma-tau, Rome, Italy). The DHA in the capsule is extracted from fish oil by PureMaxTM technology that enables lipids to be purified and concentrated to maximum standards. This ensures that the DHA used for this study is free of contaminants (heavy metals such as mercury, arsenic, cadmium, lead; oxidant impurities, dioxins and furans, dioxin-type polychlorinated biphenyls, polycyclic aromatic hydrocarbons). The packaging of the capsules in the two groups is identical. Additionally, all participants receive a free cord blood collection kit provided by SmartBank (SmartBank 
Rome, Italy). Hospital staff assisting the birth immediately extract and collect the cord blood 
with the kit. Samples are shipped to the BioVault laboratory (BioVault technical laboratory, 
Plymouth, UK) for specific analysis: volume (ml), pH, cell viability (%), number of CD34+ cells, 
number of leukocytes, bacterial and viral tests. When possible, 2 cc of the extracted cord 
blood are sent to the Lipinutragen-CNR laboratory in Bologna to determine the DHA 
percentage in the cord blood erythrocyte membranes.

Intervention type

Drug

Phase

Not Applicable

Drug names

docosahexaenoic acid

Primary outcome measures

Measure of the viability (%) and the number of CD34+ cells collected from the umbilical cord blood at birth from the patients treated with placebo or DHA from the 20th or from the 28th week.

Secondary outcome measures

Understand which stage of the supplementation with DHA (the second or the third trimester of pregnancy) is more effective in terms of quantity and viability of the stem cells, in the umbilical cord blood samples.

Overall trial start date

01/09/2010

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Absence of: diabetes, hypertension or any other type of pathology requiring pharmacological therapy, genetic diseases, chromosome abnormalities and/or congenital malformations in the foetus and the absence of infectious disease (hepatitis B, hepatitis C, HIV and cytomegalovirus).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant exclusion criteria

1. Age <18 years
2. Presence of: diabetes, hypertension or any other type of pathology requiring pharmacological therapy, genetic diseases, chromosome abnormalities and/or congenital malformations in the foetus and the presence of infectious disease (hepatitis B, hepatitis C, HIV and cytomegalovirus).
3. Cord blood samples with a volume of less than 80 ml and/or less than 70% cell vitality are excluded from the study.

Recruitment start date

01/09/2010

Recruitment end date

01/09/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Via Vittorio Locchi, 9
Rome
00197
Italy

Sponsor information

Organisation

SmartBank (Italy)

Sponsor details

Via Vittorio Locchi
9
Rome
00197
Italy
+39 06 44243328
martini@smartbank.it

Sponsor type

Industry

Website

http://www.smartbank.it

Funders

Funder type

Industry

Funder name

Private funds from SmartBank, the stem cells bank (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

BioVault Ltd (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Avantgarde s.a.s (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24884585

Publication citations

  1. Protocol

    Martini I, Di Domenico EG, Scala R, Caruso F, Ferreri C, Ubaldi FM, Lenzi A, Valensise H, 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., Trials, 2014, 15, 164, doi: 10.1186/1745-6215-15-164.

Additional files

Editorial Notes