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Endothelialized ePTFE Graft by Nanobiotechnology

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ClinicalTrials.gov Identifier: NCT02002104
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : December 5, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 6 participants
Official Title: Endothelialized ePTFE Graft by Nanobiotechnology
Study Start Date : September 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : June 2011

Group/Cohort
EPCs
No proliferation and no differentiation on the ePTFEs
Modified ePTFE
EPCs adherence, proliferation and differentiation on the ePTFEs.



Primary Outcome Measures :
  1. Isolate and expand EPCs from peripheral blood [ Time Frame: 24 weeks ]
    Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002104


Locations
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Taiwan
National Taiwan University Hospital
Taipai, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: I Hui Wu, PhD Cardiac Surgical Division, Surgical Department, National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02002104    
Other Study ID Numbers: 201009047R
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: November 2013
Keywords provided by National Taiwan University Hospital:
Expanded polytetrafluoroethylene( ePTFE)
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes