Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-30 @ 9:37 AM
Study NCT ID:
NCT05234658
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of autologous bioengineered skin', 'timeFrame': 'Through study completion, an average of 2 year', 'description': 'Incidence of adverse events related to investigational medicinal products'}, {'measure': 'Efficacy of autologous bioengineered skin', 'timeFrame': 'Through study completion, an average of 2 year', 'description': 'Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Basal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients that give their informed consent for study participation.\n2. Adult (18 years of age or older), of any sex and racial origin.\n3. Clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps. Namely, indication for Mohs surgery.\n4. Women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy.\n\nExclusion Criteria:\n\n1. Locally advanced basal cell carcinoma with evidence of tissue infiltration.\n2. Lesions in the face.\n3. Injuries requiring urgent surgical intervention.\n4. Infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.\n5. Injuries that have received treatment with radiotherapy.\n6. Contraindication for Mohs surgery.\n7. Known allergies to Biobrane dressing.\n8. Pregnant or breastfeeding women.\n9. Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.\n10. Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies."}, 'identificationModule': {'nctId': 'NCT05234658', 'briefTitle': 'Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Andalusian Network for Design and Translation of Advanced Therapies'}, 'officialTitle': 'Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'NanoGSkin-CB-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PHIT', 'description': 'Human artificial skin created by tissue engineering, composed of a sheet of autologous adult differentiated skin keratinocytes and fibroblasts expanded in a biological fibrin-agarose matrix (PHIT).', 'interventionNames': ['Biological: PHIT']}, {'type': 'EXPERIMENTAL', 'label': 'PHITAH', 'description': 'Human artificial skin created by tissue engineering, composed of a sheet of keratinocytes and differentiated autologous adult skin fibroblasts expanded in a biological fibrin-hyaluronic matrix (PHITAH).', 'interventionNames': ['Biological: PHITAH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Skin Autograft', 'description': 'Skin autograft.', 'interventionNames': ['Biological: Skin Autograft']}], 'interventions': [{'name': 'PHITAH', 'type': 'BIOLOGICAL', 'description': 'Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid', 'armGroupLabels': ['PHITAH']}, {'name': 'PHIT', 'type': 'BIOLOGICAL', 'description': 'Human artificial skin created by tissue engineering: fibrin-agarose', 'armGroupLabels': ['PHIT']}, {'name': 'Skin Autograft', 'type': 'BIOLOGICAL', 'description': 'Skin Autograft', 'armGroupLabels': ['Skin Autograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Magdalena Troya', 'role': 'CONTACT'}], 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '18014', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Salvador Arias', 'role': 'CONTACT'}], 'facility': 'Hospital U. Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ricardo Bosch', 'role': 'CONTACT'}], 'facility': 'Hospital U. Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '4109', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'David Moreno', 'role': 'CONTACT'}], 'facility': 'Hospital U. Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Macarena Guijo Molero', 'role': 'CONTACT', 'email': 'macarena.guijo@juntadeandalucia.es', 'phone': '671 537 264', 'phoneExt': '0034'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andalusian Network for Design and Translation of Advanced Therapies', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}