Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02149732
Status:
AVAILABLE
Last Update Posted:
2016-04-20
First Post:
2014-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092423', 'term': 'Limbal Stem Cell Deficiency'}, {'id': 'D013262', 'term': 'Stevens-Johnson Syndrome'}, {'id': 'D010390', 'term': 'Pemphigoid, Benign Mucous Membrane'}, {'id': 'D002057', 'term': 'Burns, Chemical'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003875', 'term': 'Drug Eruptions'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004892', 'term': 'Erythema Multiforme'}, {'id': 'D004890', 'term': 'Erythema'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D002056', 'term': 'Burns'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'AVAILABLE', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2014-05-14', 'studyFirstSubmitQcDate': '2014-05-25', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Limbal stem cell deficiency', 'Cultivated oral mucosal cell sheet transplantation', 'Ocular surface reconstruction'], 'conditions': ['Limbal Stem Cell Deficiency', 'Stevens-johnson Syndrome', 'Ocular Cicatricial Pemphigoid', 'Chemical Burn']}, 'referencesModule': {'references': [{'pmid': '15371576', 'type': 'BACKGROUND', 'citation': 'Nishida K, Yamato M, Hayashida Y, Watanabe K, Yamamoto K, Adachi E, Nagai S, Kikuchi A, Maeda N, Watanabe H, Okano T, Tano Y. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004 Sep 16;351(12):1187-96. doi: 10.1056/NEJMoa040455.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.', 'detailedDescription': 'Interventional study for treatment of patients with cicatricial change of ocular surface.\n\nSingle Group: (Limbal stem cell deficiency group)\n\nTreatment: After cultivating autologous Oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients\n\nInclusion criteria\n\n1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea\n2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment\n3. patient who agree this clinical trial\n4. patient with the eyes in which best corrected visual acuity is less than counting finger\n5. patient who is older than sixteen year old\n\nExclusion criteria\n\n1. patient who has relevant corneal transparency\n2. patient who is on the pregnancy or has a plan of pregnancy within 1 year\n3. patient who has corneal infection\n4. patient who has diagnosis of HBV, HCV, HIV, syphilis\n5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease\n6. patient who has malignancy\n7. patient who shows hypersensitivity to bovine protein.\n\nPrimary outcome Epithelization of corneal surface (6 months after cell sheet transplantation)\n\nSecondary outcome Visual acuity (6 months after cell sheet transplantation)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea\n2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment\n3. patient who agree this clinical trial\n4. patient with the eyes in which best corrected visual acuity is less than counting finger\n5. patient who is older than sixteen year old\n\nExclusion Criteria:\n\n1. patient who has relevant corneal transparency\n2. patient who is on the pregnancy or has a plan of pregnancy within 1 year\n3. patient who has corneal infection\n4. patient who has diagnosis of HBV, HCV, HIV, syphilis\n5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease\n6. patient who has malignancy\n7. patient who shows hypersensitivity to bovine protein.'}, 'identificationModule': {'nctId': 'NCT02149732', 'briefTitle': 'Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients', 'orgStudyIdInfo': {'id': 'COMET trial'}, 'secondaryIdInfos': [{'id': 'MKKim', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health & Welfare, Republic of Korea (HI11C1590)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cultivated oral mucosal epithelial sheet transplantation', 'type': 'BIOLOGICAL', 'description': 'Autologous cultivated oral mucosal epithelial cell sheet transplantation using oral mucosal adult stem cells in the patients with intractable corneal limbal deficiency'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'status': 'AVAILABLE', 'country': 'South Korea', 'contacts': [{'name': 'Mee Kum Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kmk9@snu.ac.kr', 'phone': '82-10-6277-0798'}, {'name': 'Dong Hyun Kim, MD', 'role': 'CONTACT', 'email': 'amidfree@gmail.com', 'phone': '82-10-3737-0975'}, {'name': 'Mee Kum Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'status': 'AVAILABLE', 'country': 'South Korea', 'contacts': [{'name': 'Mee Kum Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kmk9@snu.ac.kr', 'phone': '82-10-6277-0798'}], 'facility': 'Seoul National Unversity Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Mee Kum Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kmk9@snu.ac.kr', 'phone': '82-10-6277-0798'}, {'name': 'Yu Jeong Kim, MD', 'role': 'CONTACT', 'email': '21cnasa@naver.com', 'phone': '82-10-2559-1377'}], 'overallOfficials': [{'name': 'Mee Kum Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Welfare, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}