A Research Study Looking at Specific Tissue of the Umbilical Cord

Completed

• Conditions: Varices of Umbilical Cord

• Registration Number: NCT01166776
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2016-04
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Isolation and decellularization of umbilical cord Wharton's jelly matrix	Immediately upon delivery	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

Name	Time	Method
Study the ability of the isolated and decellularized matrix to support recellularization with mesenchymal stem cells and to support their growth and differentiation	Within 24 hours	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.

Trial Locations

Locations (2)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States