Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000058673
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
20/01/2014
Date last updated
20/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative Study Between Three Methods of Stem Cell Separation From Umbilical Cord Blood
Scientific title
A study comparing the effectiveness of the density gradient separation using ficoll hypaque, automated processing and harvesting system using AXP Autoxpress- Thermogenesis and magnetic bead separation system using MACS Columns and MACS Separators methods for stem cell separation from umbilical cord blood
Secondary ID [1] 283779 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stem Cells 290755 0
Stem cell separation from umbilical cord blood 290878 0
Condition category
Condition code
Inflammatory and Immune System 291116 291116 0 0
Other inflammatory or immune system disorders
Blood 291117 291117 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be carried out on 30 samples of umbilical cord blood. Each sample of cord blood will be collected from the placenta using a special collection bag containing anticoagulant (citrate phosphate dextrose adinine).

The samples will be divided into three groups:

1. 10 samples of the cord blood from which stem cells will be separated by density gradient separation using ficoll hypaque. This method is performed by centrifugation of a suspension of the cord blood mixed with ficoll-paque followed by isolation of mononuclear cells.

2. 10 samples of the cord blood from which stem cells will be separated by automated processing and harvesting system using AXP autoexpress - Thermogenesis. Cord blood is transferred into the processing bagset which is placed in the AXP device and then centrifuged. During centrifugation, component stratification and separation occurs.

3. 10 samples of the cord blood from which stem cells will be separated by magnetic bead separation system using MACS Columns and MACS Separators. That depends on labeling CD34+ cells with CD34 microbeads then, the cell suspension is loaded onto a MACS Column which is placed in the magnetic field of a MACS Separator. After removing the column from the magnetic field, the magnetically retained CD34+ cells can be eluted as the positively selected cell fraction.
Intervention code [1] 288466 0
Treatment: Other
Comparator / control treatment
Data from the 30 samples will be plotted to compare the three stem cell separation methods from umbilical cord blood to each other.
Control group
Active

Outcomes
Primary outcome [1] 291100 0
After sample stem cell separation, it will be followed by calculation of the harvested stem cells to define the stem cell separation method with the best outcome of highest stem cell count.
Timepoint [1] 291100 0
The primary outcome (stem cell count) is assessed in the same day of sample collection from the umbilical cord and stem cell separation from it using each method separately.
Secondary outcome [1] 306002 0
None
Timepoint [1] 306002 0
None

Eligibility
Key inclusion criteria
1. Mothers must have consented for cord blood collection at delivery
2. cord blood must be available for extraction of stem cells.
3. >30 weeks gestation
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Mothers who would not consent to participate in the study.
2. Chromosomal Abnormalities.
3. Congenital Anomalies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5680 0
Egypt
State/province [1] 5680 0
Alexandria

Funding & Sponsors
Funding source category [1] 288439 0
Self funded/Unfunded
Name [1] 288439 0
Country [1] 288439 0
Primary sponsor type
University
Name
Faculty of Medicine - Alexandria University
Address
Alexandria Faculty of Medicine, Champollion St.
Azarita Postcode: 21131
Alexandria
Egypt
Country
Egypt
Secondary sponsor category [1] 287141 0
None
Name [1] 287141 0
Address [1] 287141 0
Country [1] 287141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290402 0
Alexandria Faculty of Medicine Ethical Committee
Ethics committee address [1] 290402 0
Alexandria Faculty of Medicine, Champollion St.
Azarita PO box: 21131
Alexandria
Ethics committee country [1] 290402 0
Egypt
Date submitted for ethics approval [1] 290402 0
Approval date [1] 290402 0
01/12/2013
Ethics approval number [1] 290402 0

Summary
Brief summary
The aim of the work is to compare three different methods of stem cell separation from umbilical cord blood to define the stem cell separation method with the highest outcome of stem cell count
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45030 0
A/Prof Yasser Ibrahim Orief
Address 45030 0
Dr. Yasser Orief, El Mosheer Ahmed Ismail St., Panorama El shark Building Sidi gaber Elsheikh tram station above HSBC bank. Postcode: 21615
Alexandria, Egypt

Affiliation: Assistant Professor of Obstetrics and Gynecology - Faculty of Medicine - Alexandria University
Country 45030 0
Egypt
Phone 45030 0
+20 100 8233 121
Fax 45030 0
+20 3 544 22 64 (extension 102)
Email 45030 0
yaserorief@yahoo.com
Contact person for public queries
Name 45031 0
A/Prof Yasser Ibrahim Orief
Address 45031 0
Dr. Yasser Orief, El Mosheer Ahmed Ismail St., Panorama El shark Building Sidi gaber Elsheikh tram station above HSBC bank. Postcode box: 21615
Alexandria, Egypt

Affiliation: Assistant Professor of Obstetrics and Gynecology - Faculty of Medicine - Alexandria University
Country 45031 0
Egypt
Phone 45031 0
+20 100 8233 121
Fax 45031 0
+20 3 544 22 64 (extension 102)
Email 45031 0
yaserorief@yahoo.com
Contact person for scientific queries
Name 45032 0
A/Prof Yasser Ibrahim Orief
Address 45032 0
Dr. Yasser Orief, El Mosheer Ahmed Ismail St., Panorama El shark Building Sidi gaber Elsheikh tram station above HSBC bank. Postcode box: 21615
Alexandria, Egypt

Affiliation: Assistant Professor of Obstetrics and Gynecology - Faculty of Medicine - Alexandria University
Country 45032 0
Egypt
Phone 45032 0
+20 100 8233 121
Fax 45032 0
+20 3 544 22 64 (extension 102)
Email 45032 0
yaserorief@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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