Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02579993
Status:
TERMINATED
Last Update Posted:
2018-03-06
First Post:
2015-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092423', 'term': 'Limbal Stem Cell Deficiency'}, {'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Preliminar results not favorable', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2015-10-11', 'studyFirstSubmitQcDate': '2015-10-17', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective clinical evaluation', 'timeFrame': '6 months', 'description': 'A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.'}, {'measure': 'Objective clinical evaluation', 'timeFrame': '12 months', 'description': 'A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.'}], 'secondaryOutcomes': [{'measure': 'Corneal cells morphology', 'timeFrame': '6 months', 'description': 'Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology'}, {'measure': 'Corneal cells morphology', 'timeFrame': '12 months', 'description': 'Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology'}, {'measure': 'Quality of life questionnaire', 'timeFrame': '6 months', 'description': 'Modified National Eye Institute Visual Function Questionnaire 25 questionnaire'}, {'measure': 'Quality of life questionnaire', 'timeFrame': '12 months', 'description': 'Modified National Eye Institute Visual Function Questionnaire 25 questionnaire'}, {'measure': 'Visual acuity', 'timeFrame': '6 months', 'description': 'Visual acuity in the Logarithm of the Minimum Angle of Resolution scale'}, {'measure': 'Visual acuity', 'timeFrame': '12 months', 'description': 'Visual acuity in the Logarithm of the Minimum Angle of Resolution scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cornea', 'Limbal stem cell'], 'conditions': ['Limbal Stem Cell Deficiency']}, 'referencesModule': {'references': [{'pmid': '32077779', 'type': 'DERIVED', 'citation': 'Serna-Ojeda JC, Garcia-Mejia M, Graue-Hernandez EO, Navas A, Garfias Y. Short-Term Results Analysis in the Allogenic Transplantation of Limbal Stem Cells Expanded on Amniotic Membrane in Patients with Bilateral Limbal Stem Cell Deficiency. J Ocul Pharmacol Ther. 2020 May;36(4):238-246. doi: 10.1089/jop.2019.0147. Epub 2020 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.', 'detailedDescription': 'There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Bilateral limbal stem cell deficiency of any etiology.\n2. Corneal impression cytology positive for goblet cells.\n3. Ocular ultrasound results within normal parameters.\n4. Agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1\\. Active immunological diseases.'}, 'identificationModule': {'nctId': 'NCT02579993', 'briefTitle': 'ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Oftalmología Fundación Conde de Valenciana'}, 'officialTitle': 'ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation Expanded in Vitro on Amniotic Membrane in Patients With Limbal Stem Cell Deficiency.', 'orgStudyIdInfo': {'id': 'CI-051-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem Cell Transplantation', 'description': 'Cultivated Limbal Stem Cell Transplantation', 'interventionNames': ['Procedure: Pannus and conjunctival dissection', 'Procedure: Human cultivated limbal stem cell transplantation']}], 'interventions': [{'name': 'Pannus and conjunctival dissection', 'type': 'PROCEDURE', 'description': 'A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.', 'armGroupLabels': ['Stem Cell Transplantation']}, {'name': 'Human cultivated limbal stem cell transplantation', 'type': 'PROCEDURE', 'description': 'The amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured.', 'armGroupLabels': ['Stem Cell Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto de Oftalmologia Conde de Valenciana', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Yonathan Garfias, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto de Oftalmologia Conde de Valenciana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Oftalmología Fundación Conde de Valenciana', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Council of Science and Technology, Mexico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}