NCT Number: NCT01166776
A Research Study Looking at Specific Tissue of the Umbilical Cord
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
University of Kansas Medical Center, Kansas City, Kansas, United States
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
University of Kansas Medical Center
Other
Collaborators
- Children's Mercy Hospital Kansas City
Registry information
Official study title
Decellularization of Umbilical Cord Wharton's Jelly for Tissue Regenerative Applications Including Avascular Necrosis
Important dates
- Study start
- 2010
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jul 21, 2010
- Registry last updated
- Aug 22, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.