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Endothelialized ePTFE Graft by Nanobiotechnology

NCT ID: NCT02002104

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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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

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Expanded polytetrafluoroethylene( ePTFE)

Study Groups

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EPCs

No proliferation and no differentiation on the ePTFEs

No interventions assigned to this group

Modified ePTFE

EPCs adherence, proliferation and differentiation on the ePTFEs.

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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I Hui Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiac Surgical Division, Surgical Department, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipai, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201009047R

Identifier Type: -

Identifier Source: org_study_id