A Research Study Looking at Specific Tissue of the Umbilical Cord

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Kansas
Sponsor:
Collaborators:
Children's Mercy Hospital Kansas City
St. Louis Cord Blood Bank & Cellular Therapy Laboratory at SSM Cardinal Glennon Children's Medical Center
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01166776
First received: July 19, 2010
Last updated: December 30, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Kansas:

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


Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (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
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

Contacts
Contact: Omar Aljitawi, MD 913-588-6030 oaljitawi@kumc.edu
Contact: Jenny Bunch 913-945-7713 jbunch@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Omar Aljitawi, MD    913-588-6030    oaljitawi@kumc.edu   
Contact: Jenny Bunch, RN    913-945-7713    jbunch@kumc.edu   
Principal Investigator: Omar Aljitawi, MD         
Sub-Investigator: Michael Detamore, PhD         
Sub-Investigator: Rama Garimella, PhD         
Sub-Investigator: Lisa Stehno-Bittel, PhD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Sub-Investigator: Richard Hopkins, MD         
Sub-Investigator: Donna Pacicca, MD         
St. Louis Cord Blood Bank & Cellular Therapy Laboratory at SSM Cardinal Glennon Children's Medical Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: Salem Akel, PhD    314-678-5451    sakel@slcbb.org   
Sub-Investigator: Salem Akel, PhD         
Sponsors and Collaborators
University of Kansas
Children's Mercy Hospital Kansas City
St. Louis Cord Blood Bank & Cellular Therapy Laboratory at SSM Cardinal Glennon Children's Medical Center
Investigators
Principal Investigator: Omar Aljitawi, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01166776     History of Changes
Other Study ID Numbers: 12129
Study First Received: July 19, 2010
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014