Expansion of Umbilical Cord Blood Using a Unique Bio-system

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01061879
First received: February 2, 2010
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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.


Condition
Pregnancy

Study Type: Observational
Official Title: Ex Vivo Expansion of Umbilical Cord Blood Using a Unique Bio-system

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • bio-system for ex-vivo expansion of umbilical cord blood stem cells [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

umbilical cord


Enrollment: 8
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

umbilical cord collection from full-term caesarian section/normal vaginal delivery patients

Criteria

Inclusion Criteria:

  • females that consent to permit researchers collect the discarded umbilical cords from the placenta and use for research purposes.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061879

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Omar Aljitawi, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01061879     History of Changes
Other Study ID Numbers: 11973
Study First Received: February 2, 2010
Last Updated: December 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
umbilical cord
umbilical cord blood collection
pregnancy

ClinicalTrials.gov processed this record on August 28, 2014