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A Research Study Looking at Specific Tissue of the Umbilical Cord

This study has been completed.
Sponsor:
Collaborator:
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT01166776
First received: July 19, 2010
Last updated: August 19, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to isolate Umbilical cord Wharton's jelly matrix to be used as a scaffold for tissue regenerative applications, including avascular necrosis.

Condition
Varices of Umbilical Cord

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Decellularization of Umbilical Cord Wharton's Jelly for Tissue Regenerative Applications Including Avascular Necrosis

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Isolation and decellularization of umbilical cord Wharton's jelly matrix [ Time Frame: Immediately upon delivery ] [ Designated as safety issue: No ]
    Use the Wharton's Jelly matrix as a scaffold, we should be able to remove the cellular components of Wharton's Jelly. This decellularization process will help decrease antigenicity and accordingly avoid allosensitization. Additionally, the matrix should be able to provide a 3 dimensional (3D) environment needed for biologic and geometric recellularization.


Secondary Outcome Measures:
  • Study the ability of the isolated and decellularized matrix to support recellularization with mesenchymal stem cells and to support their growth and differentiation [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]
    Use the decellularized matrix for tissue regeneration purposes, it should be able to support recellularization with undifferentiated mesenchymal stem cells and help support their differentiation into different tissues, including bone or cartilage.


Biospecimen Retention:   Samples With DNA
umbilical cord tissue

Enrollment: 64
Study Start Date: June 2010
Study Completion Date: July 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Umbilical cord
To isolate Umbilical cord Wharton's jelly matrix to be used as a scaffold for tissue regenerative applications, including avascular necrosis.

Detailed Description:
Our working hypothesis is that umbilical cord blood Wharton's Jelly matrix has all the biochemical and biomechanical characteristics needed in an ideal scaffold for tissue engineering. Accordingly, we expect matrix to support the growth and differentiation of transplanted mesenchymal stem cells. The first step in this effort is to isolate Wharton's Jelly matrix by decellularization. The second step will be to test the ability of this matrix to support the growth and differentiation of transplanted mesenchymal stem cells. The third step will be to pursue preliminary animal testing to study the ability of this matrix to support bone tissue regeneration in vivo.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women at time of delivery
Criteria

Inclusion Criteria:

  • Pregnant Women
  • 18 years of age or older
  • willing to donate umbilical cord units

Exclusion Criteria:

  • less than 18 years of age
  • Has Hepatitis or HIV
  • Considered High Risk
  • Scheduled for C-Section due to complications during current pregnancy
  • Delivered prior to Full Term
  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: NCT01166776

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Kansas Medical Center
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Omar Aljitawi, MD University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01166776     History of Changes
Other Study ID Numbers: 12129 
Study First Received: July 19, 2010
Last Updated: August 19, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
Wharton's jelly
umbilical cord
decellularization

ClinicalTrials.gov processed this record on December 08, 2016