Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-13 @ 7:11 AM
Study NCT ID:
NCT02002104
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2013-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelialized ePTFE Graft by Nanobiotechnology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-29', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-11-29', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isolate and expand EPCs from peripheral blood', 'timeFrame': '24 weeks', 'description': 'Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Expanded polytetrafluoroethylene( ePTFE)'], '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.']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT02002104', 'briefTitle': 'Endothelialized ePTFE Graft by Nanobiotechnology', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Endothelialized ePTFE Graft by Nanobiotechnology', 'orgStudyIdInfo': {'id': '201009047R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EPCs', 'description': 'No proliferation and no differentiation on the ePTFEs'}, {'label': 'Modified ePTFE', 'description': 'EPCs adherence, proliferation and differentiation on the ePTFEs.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipai', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital'}], 'overallOfficials': [{'name': 'I Hui Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiac Surgical Division, Surgical Department, National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}