Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT01242618
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2010-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-19', 'studyFirstSubmitDate': '2010-11-16', 'studyFirstSubmitQcDate': '2010-11-16', 'lastUpdatePostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety: post operative complications should not be at higher rate than gold standard operative procedure.', 'timeFrame': '12 months post reconstruction', 'description': 'Post operative complications could be: infections, bleeding, formation of scar tissue, asymmetry of the nostril to the opposite side'}], 'secondaryOutcomes': [{'measure': 'feasibility of treatment', 'timeFrame': '12 months post reconstruction', 'description': 'Functional testing of breathing Questionnaire of evaluation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nasal cartilage diseases'], 'conditions': ['Skin Carcinoma']}, 'referencesModule': {'references': [{'pmid': '23564241', 'type': 'BACKGROUND', 'citation': 'Fulco I, Largo RD, Miot S, Wixmerten A, Martin I, Schaefer DJ, Haug MD. Toward clinical application of tissue-engineered cartilage. Facial Plast Surg. 2013 Apr;29(2):99-105. doi: 10.1055/s-0033-1341589. Epub 2013 Apr 5.'}, {'pmid': '24726477', 'type': 'RESULT', 'citation': 'Fulco I, Miot S, Haug MD, Barbero A, Wixmerten A, Feliciano S, Wolf F, Jundt G, Marsano A, Farhadi J, Heberer M, Jakob M, Schaefer DJ, Martin I. Engineered autologous cartilage tissue for nasal reconstruction after tumour resection: an observational first-in-human trial. Lancet. 2014 Jul 26;384(9940):337-46. doi: 10.1016/S0140-6736(14)60544-4. Epub 2014 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft, obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane, in the alar lobule of patients after resection of a non melanoma skin cancer.', 'detailedDescription': 'Skin cancer is the most prevalent reason for surgically creating a multilayer defect, consisting of skin and cartilage, of the alar lobule of the nose. In reconstruction of these defects, a combination of local flaps and autologous cartilage, typically harvested from the nasal septum or the ear, is used to restore the stability, function and proper 3D shape of the alar lobule. Harvesting autologous cartilage from the ear has been associated with a number of complications that could be overcome by the use of engineered cartilage graft generated in vitro with autologous cells.\n\nThis study is a phase I, prospective, uncontrolled, investigator initiated clinical trial involving 5 patients, with the objective of demonstrating safety and feasibility in the use of engineered nasal cartilage grafts. The specific surgical target of the trial is the reconstruction of a two layer defect of the alar lobule using a tissue engineered nasal cartilage graft and a local flap, following resection of a non melanoma skin cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* size of defect: ≥50% of alar subunit\n* Extent of defect: 2 layer defect: skin and fibro-cartilaginous tissues\n\nExclusion Criteria:\n\n* Defect extent:3 layers defect, including mucosa\n* defect extent: 1 layer defect\n* pregnancy\n* immunodeficiency HIV\n* Hepatitis B, C\n* Allergy to porcine collagen, penicillin or streptomycin\n* Chronic treatment with steroids or growth factors (immunomodulatory drugs)'}, 'identificationModule': {'nctId': 'NCT01242618', 'briefTitle': 'Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule Following Resection of a Non Melanoma Skin Cancer- a Phase I Clinical Trial.', 'orgStudyIdInfo': {'id': 'TpP-I-2010-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'engineered nasal cartilage graft', 'description': 'Biological intervention: autologous nasal chondrocytes expanded in vitro and cultured in a collagen Type I/III scaffold', 'interventionNames': ['Biological: engineered nasal cartilage graft']}], 'interventions': [{'name': 'engineered nasal cartilage graft', 'type': 'BIOLOGICAL', 'description': 'implantation of engineered nasal cartilage grafts in the alar lobule', 'armGroupLabels': ['engineered nasal cartilage graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Ivan Martin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}