Endothelialized ePTFE Graft by Nanobiotechnology

NCT ID: NCT02002104

Last Updated: 2013-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-06-30

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.

Conditions

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.

Study Groups

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

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

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I Hui Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiac Surgical Division, Surgical Department, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipai, , Taiwan

Countries

Taiwan

Other Identifiers

201009047R

Identifier Type: -

Identifier Source: org_study_id