A Research Study Looking at Specific Tissue of the Umbilical Cord

August 19, 2016 updated by: University of Kansas Medical Center

Decellularization of Umbilical Cord Wharton's Jelly for Tissue Regenerative Applications Including Avascular Necrosis

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women at time of delivery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Umbilical cord
To isolate Umbilical cord Wharton's jelly matrix to be used as a scaffold for tissue regenerative applications, including avascular necrosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isolation and decellularization of umbilical cord Wharton's jelly matrix
Time Frame: 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.
Immediately upon delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (ESTIMATE)

July 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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