Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT01562002
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2012-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2012-03-22', 'lastUpdatePostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viability and safety of mesenchymal stem cell transplant', 'timeFrame': '1 Year', 'description': 'Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy'}], 'secondaryOutcomes': [{'measure': 'Absence of complications in pre and peri surgical implantation', 'timeFrame': '1 Week', 'description': 'Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification.'}, {'measure': 'Improvement of 2 lines in Best Corrected Visual Acuity', 'timeFrame': '12 month', 'description': 'Improvement in visual acuity compared to baseline values before transplant'}]}, 'conditionsModule': {'keywords': ['limbus', 'cornea', 'insufficiency syndrome', 'stem cell transplant'], 'conditions': ['Limbus Corneae Insufficiency Syndrome']}, 'referencesModule': {'references': [{'pmid': '37773479', 'type': 'DERIVED', 'citation': 'Perez I, Galindo S, Lopez-Miguel A, Nieto-Miguel T, de la Mata A, Lopez-Paniagua M, Alberca M, Herreras JM, Calonge M. In Vivo Confocal Microscopy in Limbal Stem Cell Deficiency After Mesenchymal Stem Cell Transplantation: A Sub-analysis from a Phase I-II Clinical Trial. Ophthalmol Ther. 2023 Dec;12(6):3251-3262. doi: 10.1007/s40123-023-00809-7. Epub 2023 Sep 29.'}, {'pmid': '30578758', 'type': 'DERIVED', 'citation': 'Calonge M, Perez I, Galindo S, Nieto-Miguel T, Lopez-Paniagua M, Fernandez I, Alberca M, Garcia-Sancho J, Sanchez A, Herreras JM. A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency. Transl Res. 2019 Apr;206:18-40. doi: 10.1016/j.trsl.2018.11.003. Epub 2018 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female older than 18 years.\n* Signed Informed consent\n* Negative pregnancy test at inclusion for any potential childbearing female.\n* Compromise of contraceptive method during all trial for any potential childbearing female.\n* Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology.\n* Availability for all the scheduled visits during the study\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis.\n* Active ocular infection in any eye. If the infection can be cured, inclusion can be considered after 30 days of inactive infection since its end.\n* Alterations in lid statics / dynamics or any other pathology (e.g. severe dry eye syndrome) except the one that originated the Limbus Insufficience that under medical opinion might alter the results. Any of these must be corrected 3 months prior to patient inclusion, before reconsidering rescreening.\n* Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available.\n* No availability for all scheduled visits during the study.\n* Any other circumstance under investigator´s opinion that prevents patient inclusion even though normal inclusion and exclusion criteria are met.'}, 'identificationModule': {'nctId': 'NCT01562002', 'briefTitle': 'Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA'}, 'officialTitle': 'Advanced Therapy for Ocular Surface Reconstruction. Allogenic Limbus Epithelial Stem-cell Transplant vs Bone Marrow Mesenchymal Stem-cell Transplant in Limbus Insufficiency Syndrome. Double-masked Randomized Trial', 'orgStudyIdInfo': {'id': 'IOBA-05-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone Marrow mesenchymal stem cell', 'description': 'Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant', 'interventionNames': ['Procedure: Stem Cell with Amniotic Membrane Transplant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allogenic limbal stem cell Transplant', 'description': 'Stem Cell with Amniotic Membrane Transplant', 'interventionNames': ['Procedure: Stem Cell with Amniotic Membrane Transplant']}], 'interventions': [{'name': 'Stem Cell with Amniotic Membrane Transplant', 'type': 'PROCEDURE', 'description': 'Single stem cell expansion in amniotic membrane transplant', 'armGroupLabels': ['Allogenic limbal stem cell Transplant', 'Bone Marrow mesenchymal stem cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47011', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'IOBA', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Margarita Calonge, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valladolid', 'class': 'OTHER'}, {'name': 'Centro en Red de Medicina Regenerativa de Castilla y Leon', 'class': 'OTHER'}, {'name': 'Red de Terapia Celular', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}