Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-11 @ 4:32 PM
Study NCT ID:
NCT00978705
Status:
UNKNOWN
Last Update Posted:
2009-09-17
First Post:
2009-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-15', 'studyFirstSubmitDate': '2009-04-15', 'studyFirstSubmitQcDate': '2009-09-15', 'lastUpdatePostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'engraftment assessment', 'timeFrame': '4week'}], 'secondaryOutcomes': [{'measure': 'the vancouver burn scar scale', 'timeFrame': '8, 12, 24 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Keratinocyte Cell', 'severe burn wound'], 'conditions': ['Burn Wound']}, 'descriptionModule': {'briefSummary': 'The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : 1\\~70 years\n* More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn\n* Must provide signed informed consent prior to participation in any study-related procedures\n\nExclusion Criteria:\n\n* Have a pyogenic infection\n* Part of the facial cosmetic surgery cost\n* Hypersensitivity reactions in patients with bovine proteins\n* Hypersensitivity reactions in patients with Gentamycin\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT00978705', 'acronym': 'keratinocyte', 'briefTitle': 'Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosolution Co., Ltd.'}, 'officialTitle': 'Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood', 'orgStudyIdInfo': {'id': 'MCTT-KRH-06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Autologous cultured keratinocyte cell', 'type': 'DRUG', 'otherNames': ['Keraheal'], 'description': '3x10\\^7 cell/ vial'}]}, 'contactsLocationsModule': {'locations': [{'zip': '150-030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hangang Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Wook Chun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hangang Sacred Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosolution Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Yunyoung Kim / Senior Research Scientist', 'oldOrganization': 'Modern Cell and Tissue Technology'}}}}