A Research Study Looking at Specific Tissue of the Umbilical Cord

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01166776

Enrollment

Registered

2010-07-21

Start date

2010-06-30

Completion date

2016-07-31

Last updated

2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varices of Umbilical Cord

Keywords

Wharton's jelly, umbilical cord, decellularization

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results