PregnancyNCT01061879
Expansion of Umbilical Cord Blood Using a Unique Bio-system
An observational study of Pregnancy, run by University of Kansas at 1 site in United States.
Trial summary
By doing this study, researchers hope to develop a special technique and laboratory conditions to help support umbilical stem cell growth and multiplication. In this project, researchers propose a three dimensional (3D) microenvironment that mimics the bone marrow stem cell microenvironment, with its supporting cells… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: umbilical cord collection from full-term caesarian section/normal vaginal delivery patients
Who may be able to join
- females that consent to permit researchers collect the discarded umbilical cords from the placenta and use for research purposes.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Ex Vivo Expansion of Umbilical Cord Blood Using a Unique Bio-system
By doing this study, researchers hope to develop a special technique and laboratory conditions to help support umbilical stem cell growth and multiplication.
In this project, researchers propose a three dimensional (3D) microenvironment that mimics the bone marrow stem cell microenvironment, with its supporting cells of osteoblasts and stromal cells. In theory, this will result in better expansion of cord blood stem cells ex vivo.
Read the detailed description
To successfully expand umbilical cord blood stem cells ex vivo, a microenvironment that resembles the stem cell microenvironment, or stem cell 'niche' should be created. In designing this bio-system, we make use of several observations. First, bone osteoblasts are important in promoting hematopoietic stem cell expansion, accordingly, this bio-system will ensure the physical proximity of the cord blood stem cells to a 3D bone tissue derived from mesenchymal stem cells (MSCs). These MSCs will be isolated from Wharton's jelly, and by using an osteogenic medium and special scaffolds, these MSCs will differentiate into osteogenic progenitors creating a 3D bone structure. The other observation is that, co-culture of cord blood stem cells with mesenchymal stem cells is superior to liquid cultures in terms of ex vivo expansion , accordingly, in this experiment, undifferentiated MSCs will be co-cultured with cord blood stem cells in this created 3D bone structure. This is a unique design that has the potential to expand cord blood stem cells more efficiently.
- Conditions
- Pregnancy
- Keywords
- umbilical cord, umbilical cord blood collection, pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
bio-system for ex-vivo expansion of umbilical cord blood stem cells
To successfully expand the umbilical cord blood stem cells, a microenvironment that resembles the stem cell microenvironment, or stem cell 'niche' should be created. In designing this bio-system, we make use of several observations. Firstly, bone osteoblasts are important in promoting hematopoietic stem cell expansion , accordingly, this bio-system will ensure the physical proximity of the cord blood stem cells to a 3D bone tissue derived from mesenchymal stem cells (MSCs). These MSCs will be isolated from Wharton's jelly, and by using an osteogenic medium and special scaffolds, these MSCs will differentiate into osteogenic progenitors creating a 3D bone structure . The other observation is that, co-culture of cord blood stem cells with mesenchymal stem cells is superior to liquid cultures in terms of ex vivo expansion , accordingly, in this experiment, undifferentiated MSCs will be co-cultured with cord blood stem cells in the created 3D bone structure.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Aljitawi, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061879
- Sponsor's protocol ID
- 11973
- Status last verified
- Dec 2012
- First submitted
- 2 Feb 2010
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Expansion of Umbilical Cord Blood Using a Unique Bio-system
- ClinicalTrials.gov ID
- NCT01061879
- Acronym / sponsor ID
- 11973
- Conditions
- Pregnancy
- Keywords
- umbilical cord, umbilical cord blood collection, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By doing this study, researchers hope to develop a special technique and laboratory conditions to help support umbilical stem cell growth and multiplication.
In this project, researchers propose a three dimensional (3D) microenvironment that mimics the bone marrow stem cell microenvironment, with its supporting cells of osteoblasts and stromal cells. In theory, this will result in better expansion of cord blood stem cells ex vivo.
Detailed description
To successfully expand umbilical cord blood stem cells ex vivo, a microenvironment that resembles the stem cell microenvironment, or stem cell 'niche' should be created. In designing this bio-system, we make use of several observations. First, bone osteoblasts are important in promoting hematopoietic stem cell expansion, accordingly, this bio-system will ensure the physical proximity of the cord blood stem cells to a 3D bone tissue derived from mesenchymal stem cells (MSCs). These MSCs will be isolated from Wharton's jelly, and by using an osteogenic medium and special scaffolds, these MSCs will differentiate into osteogenic progenitors creating a 3D bone structure. The other observation is that, co-culture of cord blood stem cells with mesenchymal stem cells is superior to liquid cultures in terms of ex vivo expansion , accordingly, in this experiment, undifferentiated MSCs will be co-cultured with cord blood stem cells in this created 3D bone structure. This is a unique design that has the potential to expand cord blood stem cells more efficiently.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- umbilical cord collection from full-term caesarian section/normal vaginal delivery patients
Key inclusion criteria (1 listed)
- females that consent to permit researchers collect the discarded umbilical cords from the placenta and use for research purposes.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
bio-system for ex-vivo expansion of umbilical cord blood stem cells
Time frame: one year
To successfully expand the umbilical cord blood stem cells, a microenvironment that resembles the stem cell microenvironment, or stem cell 'niche' should be created. In designing this bio-system, we make use of several observations. Firstly, bone osteoblasts are important in promoting hematopoietic stem cell expansion , accordingly, this bio-system will ensure the physical proximity of the cord blood stem cells to a 3D bone tissue derived from mesenchymal stem cells (MSCs). These MSCs will be isolated from Wharton's jelly, and by using an osteogenic medium and special scaffolds, these MSCs will differentiate into osteogenic progenitors creating a 3D bone structure . The other observation is that, co-culture of cord blood stem cells with mesenchymal stem cells is superior to liquid cultures in terms of ex vivo expansion , accordingly, in this experiment, undifferentiated MSCs will be co-cultured with cord blood stem cells in the created 3D bone structure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Aljitawi, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bio-system for ex-vivo expansion of umbilical cord blood stem cells (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.