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Endothelialized ePTFE Graft by Nanobiotechnology

Primary Purpose

The Apparatus for Processing the Tubular Graft Modification Will be Designed and Evaluated., The On-site Capturing of the Endothelial (Progenitor) Cells by Peptide-mediated Selective Adhesion in Vitro and in Vivo Will Also be Elucidated., The Patency Rate of ITRI-made Artificial Blood Vessels Will be Evaluated by the Porcine Animal Model.

Status
Completed
Phase
Locations
Taiwan
Study Type
Observational
Intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for The Apparatus for Processing the Tubular Graft Modification Will be Designed and Evaluated. focused on measuring Expanded polytetrafluoroethylene( ePTFE)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers
Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation) Times - sampled 20 ~ 40ml / time, 2 to 3 times / month

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

EPCs

Modified ePTFE

Arm Description

No proliferation and no differentiation on the ePTFEs

EPCs adherence, proliferation and differentiation on the ePTFEs.

Outcomes

Primary Outcome Measures

Isolate and expand EPCs from peripheral blood
Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation)

Secondary Outcome Measures

Full Information

First Posted
October 23, 2013
Last Updated
November 29, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02002104
Brief Title
Endothelialized ePTFE Graft by Nanobiotechnology
Official Title
Endothelialized ePTFE Graft by Nanobiotechnology
Study Type
Observational

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The replacement of autologous blood vessels by artificial grafts is urgently needed in clinical applications. Expanded polytetrafluoroethylene (ePTFE) grafts are the most clinically used artificial blood vessels because of its chemical and mechanical stability. But, when used as arteriovenous (AV) grafts for haemodialysis, small diameter ePTFE grafts have a high failure rate of 40% in three years in vivo because of the functional lack of an intact endothelial cell layer. Here we developed a two-step modification including chemical etching and plasma activation to enhance the hydrophilicity of ePTFE. Peptide motifs (eg. cyclic RRE, RGD) known to bind integrins on the endothelial cells were immobilized on ePTFE grafts. Functional peptide immobilization significantly increased the adherence and growth of HUVEC cells on ePTFEs. Patch ePTFE implantation in the pig's descending aorta was used to evaluate the in vivo endothelialization of these modified ePTFE grafts. At 28 days implantation, newly formed endothelial layers on peptide-immobilized ePTFE grafts were demonstrated by SEM and histological analysis. These preliminary data showed the potential to grow an intact endothelial layer to improve the patency rate of the modified ePTFE grafts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Apparatus for Processing the Tubular Graft Modification Will be Designed and Evaluated., The On-site Capturing of the Endothelial (Progenitor) Cells by Peptide-mediated Selective Adhesion in Vitro and in Vivo Will Also be Elucidated., The Patency Rate of ITRI-made Artificial Blood Vessels Will be Evaluated by the Porcine Animal Model.
Keywords
Expanded polytetrafluoroethylene( ePTFE)

7. Study Design

Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPCs
Arm Description
No proliferation and no differentiation on the ePTFEs
Arm Title
Modified ePTFE
Arm Description
EPCs adherence, proliferation and differentiation on the ePTFEs.
Primary Outcome Measure Information:
Title
Isolate and expand EPCs from peripheral blood
Description
Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation) Times - sampled 20 ~ 40ml / time, 2 to 3 times / month
Study Population Description
Native arteriovenous fistulas are not available in up to 40 percent of patients with renal dialysis. Therefore, the replacement of autologous blood vessels by artificial grafts is urgently needed. Expanded polytetrafluoroethylene( ePTFE) grafts are the most clinically used artificial blood vessels.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I Hui Wu, PhD
Organizational Affiliation
Cardiac Surgical Division, Surgical Department, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipai
Country
Taiwan

12. IPD Sharing Statement

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Endothelialized ePTFE Graft by Nanobiotechnology

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