Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-04-13 @ 9:29 PM
Study NCT ID:
NCT03839069
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013262', 'term': 'Stevens-Johnson Syndrome'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D010390', 'term': 'Pemphigoid, Benign Mucous Membrane'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'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': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-10', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2019-02-10', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation", 'timeFrame': "the Schirmer's test will be performed every three months until 12 months after operation", 'description': "to compare the Schirmer's test between baseline and 12 months after operation. The higher Schirmer's test results, the better tear secretion function."}, {'measure': 'the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation', 'timeFrame': 'the OSDI will be monitored every three months until 12 months', 'description': 'to compare the OSDI between baseline and 12 months after operation. The higher the OSDI value, the worse of subjective ocular surface disease related symptoms.'}, {'measure': 'the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation', 'timeFrame': 'the COCS will be monitored every three months until 12 months after operation', 'description': 'to compare the COCS between baseline and 12 months after operation. The higher the COCS scores, the more ocular surface complications.'}], 'secondaryOutcomes': [{'measure': 'the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation', 'timeFrame': 'the impression cytology will be performed every three months until 12 months after operation', 'description': 'to compare the scores of conjunctival impression cytology between baseline and 12 months after operation. The higher the conjunctival impression cytology scores, the worse squamous metaplasia of the ocular surface.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cicatrizing Conjunctivitis', 'Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum', 'Sjogren Syndrome', 'Mucous Membrane Pemphigoid', 'Chronic Graft Versus Host Disease', 'Chemical Burn to Eye']}, 'descriptionModule': {'briefSummary': 'This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.', 'detailedDescription': 'Cicatrizing conjunctivitis can be the common presentation of many ocular surface diseases as Stevens-Johnson syndrome (SJS), mucous membrane pemphigoid (MMP), chemical burn, Sjogren syndrome, chronic graft-versus-host disease (GVHD) and ocular trauma. Ocular dryness in combination with symblepharon and corneal opacity in these patients could lead to the poor visual and life quality, and less favorable prognosis of ocular reconstruction.\n\nThis study aims to prospectively evaluate the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis. The investigators evaluate the saliva-tear productivity (functional outcome) and the survival of graft (anatomical outcome) every three months. The investigators would also validate whether minor salivary gland transplantation is beneficial for the participant prior to further ocular reconstruction as limbal transplantation and corneal grafting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20-85 years old\n* unilateral or bilateral cicatrizing conjunctivitis\n* severe aqueous deficiency dry eye ( Schirmer I test result of less than 2mm)\n* chronic ocular surface disease score (COCS) over 3 points\n* Oxford scheme over grade III\n\nExclusion Criteria:\n\n* active ocular infection\n* active corneal melting\n* severe xerostomia (modified Schirmer I test result of less than 25mm)'}, 'identificationModule': {'nctId': 'NCT03839069', 'briefTitle': 'Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis', 'orgStudyIdInfo': {'id': '201503027DINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minor Salivary Gland Transplantation', 'description': 'Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.', 'interventionNames': ['Procedure: minor salivary gland transplantation']}], 'interventions': [{'name': 'minor salivary gland transplantation', 'type': 'PROCEDURE', 'description': 'The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.', 'armGroupLabels': ['Minor Salivary Gland Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10002', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsiao Sang Chu, MD,MS', 'role': 'CONTACT', 'email': 'stephaniechu@ntuh.gov.tw', 'phone': '+886-2-23123456', 'phoneExt': '63804'}], 'facility': 'Department of Ophthalmology, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hsiao-Sang Chu, MD, MS', 'role': 'CONTACT', 'email': 'stephaniechu@ntuh.gov.tw', 'phone': '+886-2-23123456', 'phoneExt': '63804'}], 'overallOfficials': [{'name': 'Hsiao-Sang Chu, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, NTUH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'for research purpose only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}