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Normal Full-Term DeliveriesNCT00731744

Generation of Dendritic Cell Precursors From Cord Blood Stem Cells

A study testing Normal full-term deliveries in people with Normal Full-Term Deliveries, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

There is a growing interest in generating dendritic cells (DCs) for using as vaccines. Several cytokines, especially stem cell factor (SCF) and FLT3-ligand (FL), have been identified as essential to produce large numbers of myeloid precursors and even to increase DC yield obtained by the action of… Read more about this study

Who is it for?
Ages 25 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Normal Full-Term Deliveries
What is being tested?
Normal full-term deliveries
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteTaiwan
Study dates
Jan 2007to Dec 2010
Phase
Interventional
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 25 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Normal full-term deliveries

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Chien-Nan Lee, Associate Professor contact

886-2-23123456 ext. 5166

leecn@ntu.edu.tw

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    Chien-Nan Lee, ASSOCIATE PROFESSOR, 886-2-23123456 ext. 5166, leecn@ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

There is a growing interest in generating dendritic cells (DCs) for using as vaccines. Several cytokines, especially stem cell factor (SCF) and FLT3-ligand (FL), have been identified as essential to produce large numbers of myeloid precursors and even to increase DC yield obtained by the action of granulocyte-macrophage colony-stimulating factor (GM-CSF) and tumor necrosis factor alpha (TNF-α). However, there are few studies on the effect of the early-acting cytokines, commonly used to expand CD34+ progenitor cells, on DC generation.

We have established a serious of functional analysis of maturated or immaturated DCs including surface markers screening or cytokine production. Here, we design this two-year project to evaluate the possible methodology in the generation of CD14+CD1a- and CD14- CD1a+ myeloid DC precursors from CD34+ cells. In the first year of the project, we will set up the standard protocol to generate DC precursors from cord blood stem cells. In the first step, we will isolate CD34+ cells from cord blood and amplify these cells. Purity of the CD34+ cell populations obtained will be greater than 90%. In the next step, these primary cultures of CD34+ cells will treat with early-acting cytokines such as GM-CSF and IL-4 to further induction into dendritic cells. Functional analysis of dendritic cells would be performed in this stage. In the second year of the project, we will further evaluate the induction of DCs by CD34+ stem cells could be affected by combination of mesenchymal stromal cells. These results of this research with CD34+-based DCs induction provide the basis for materials to develop the DC-based vaccine against viral and fungal infections, and might be a powerful tool in anti-tumor immunotherapy.

Being tested
Normal full-term deliveries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal full-term deliveriesProcedure or surgery

    Normal full-term deliveries by standard procedures according to institutional guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. None, we isolate stem cells from cord blood.

    Measured: from CS operation to close

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2008 (estimated)
  2. Study startJan 2007
  3. Primary completionFeb 2007
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731744
Sponsor's protocol ID
200706003R
Status last verified
Aug 2008
First submitted
7 Aug 2008
Last updated
11 Aug 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Normal full-term deliveries in people with Normal Full-Term Deliveries, run by National Taiwan University Hospital at 1 site in Taiwan.

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 0 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: status not confirmed, as of the sponsor's last update on 11 Aug 2008. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chien-Nan Lee, Associate Professor (886-2-23123456 ext. 5166, leecn@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

None, we isolate stem cells from cord blood. (time frame: from CS operation to close). 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 11 Aug 2008.

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