Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-03 @ 2:34 AM
Study NCT ID:
NCT02959333
Status:
UNKNOWN
Last Update Posted:
2016-11-09
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001983', 'term': 'Bronchial Fistula'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D016156', 'term': 'Respiratory Tract Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2016-11-03', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'median time for fistula closure', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'complication', 'timeFrame': '1 year', 'description': 'fever, coughing up blood, infection...'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bronchial Fistula']}, 'descriptionModule': {'briefSummary': 'Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.\n\nThe investigators will conduct endoscopic injection of human amniotic epithelial cells to fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the application of human amniotic epithelial cells in the treatment of bronchial fistula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with bronchial fistula by Imaging or bronchoscopic examination\n* typical symptom of bronchial fistula, such as fever, cough, purulent sputum, weight loss…\n* patients present compromised conditions, who can only accept a conservative treatment.\n\nExclusion Criteria:\n\n* absolute contraindication of bronchoscopic examination and treatment\n* with previous treatment of cell therapy, including stem cells.'}, 'identificationModule': {'nctId': 'NCT02959333', 'briefTitle': 'Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula', 'orgStudyIdInfo': {'id': 'hAEC-BF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hAEC treatment', 'description': 'hAEC: human amniotic epithelial cells 3-5\\*10\\^7 /5 ml', 'interventionNames': ['Biological: hAEC']}], 'interventions': [{'name': 'hAEC', 'type': 'BIOLOGICAL', 'description': 'hAEC: human amniotic epithelial cells', 'armGroupLabels': ['hAEC treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '362000', 'city': 'Quanzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongzhi Gao, Dr.', 'role': 'CONTACT', 'email': '1564747628@qq.com', 'phone': '0595-22766122'}], 'facility': 'The Second Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 24.91389, 'lon': 118.58583}}], 'centralContacts': [{'name': 'Yimin Zeng, Dr.', 'role': 'CONTACT', 'email': 'zeng_yi_ming@126.com', 'phone': '0595-22766122'}], 'overallOfficials': [{'name': 'Yimin Zeng, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Fujian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}