Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-11 @ 6:35 PM
Study NCT ID:
NCT07239895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical symptoms', 'timeFrame': '12 and 24 weeks after treatment', 'description': 'Cough, wheezing, respiratory rate are included in clinical symptomes. Both status and frequency would be evaluated.'}, {'measure': 'Changes in oxygen therapy', 'timeFrame': '24 weeks after treatment', 'description': 'Oxygen saturation (SpO₂), oxygen therapy settings, and daily duration of oxygen therapy would be evaluated.'}], 'secondaryOutcomes': [{'measure': 'Changes in general condition', 'timeFrame': '24 weeks after treatment', 'description': 'Rate of weight gain, time of independent activity are evaluated as general condition.'}, {'measure': 'Change in lung diffusing capacity for carbon monoxide (DLCO) from baseline', 'timeFrame': '12 and 24 weeks after treatment', 'description': 'DLCO is a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.'}, {'measure': 'Change in forced expiratory volume in one second (FEV1) from baseline', 'timeFrame': '12 and 24 weeks after treatment', 'description': 'FEV1 is the volume of breath exhaled with effort in one second.'}, {'measure': 'Change in forced vital capacity (FVC) from baseline', 'timeFrame': '12 and 24 weeks after treatment', 'description': 'FVC is the full amount of air that can be exhaled with effort in a complete breath'}, {'measure': 'Change in high resolution computed tomography (HRCT) from baseline', 'timeFrame': '24 weeks after treatment', 'description': 'HRCT scan is a type of CT scan that shows detailed pictures of lungs'}, {'measure': 'Bronchiolitis Obliterans (BO) exacerbation', 'timeFrame': '24 weeks after treatment', 'description': 'Frequency and severity of events will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airway Basal Stem Cells', 'Bronchiolitis obliterans', 'Bronchiolar Epithelium', 'Pedatric Bronchiolitis Obliterans'], 'conditions': ['Pediatric Bronchiolitis Obliterans']}, 'descriptionModule': {'briefSummary': 'Bronchiolitis obliterans (BO) is a chronic lung disease which was initiated with injury of the bronchiolar epithelium and resulted in nonuniform luminal obliteration or narrowing. Among children, the most common form of BO is post-infectious BO with a lack of treatment guidelines or standard therapy. In this study, an open, single-armed study is performed to preliminarily evaluate the safety and efficacy of airway basal stem cells on treatment of pediatric BO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females, aged between 28 days and 18 years;\n* Diagnosed with bronchiolitis obliterans according to the guidelines;\n* Meeting at least one of the following: FEV1 \\< 55% of predicted value; requiring continuous assisted mechanical ventilation or oxygen therapy;\n* None of acute infections within the past four weeks;\n* Tolerating bronchoscopy;\n* The child and/or parent(s) provide informed consent, and are able to understand and adhere to scheduled visits, treatments, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Subjects with bronchiolitis obliterans syndrome (BOS) who are on a current cGVHD treatment regimen at screening.\n* At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test. Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well.\n* Subject who is assessed to have major lung diseases other than BO by investigators at screening or who has other severe systemic diseases within 6 months prior to screening and is considered to be unsuitable for this study by investigators.\n* Presence of severe coagulation dysfunction at screening and may compromise the safety of bronchoscopy in the investigator's judgment.\n* Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet aggregation therapy, and for whom, in the investigator's assessment, the medication cannot be discontinued within a week prior to cell collection and infusion.\n* Subjects with suicide risk or a history of psychiatric disorders at screening.\n* Participation in another interventional clinical study within 3 months prior to screening.\n* Poor compliance, making him or her difficult to complete the study.\n* Subjects who is considered to be unsuitable for this study in in the opinion of the investigator."}, 'identificationModule': {'nctId': 'NCT07239895', 'briefTitle': 'Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regend Therapeutics'}, 'officialTitle': 'Exploratory Study of Airway Basal Stem Cells on Treatment of Pediatric Bronchiolitis Obliterans', 'orgStudyIdInfo': {'id': 'BO-V1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Airway Basal Stem Cells', 'interventionNames': ['Biological: Airway Basal Stem Cells']}], 'interventions': [{'name': 'Airway Basal Stem Cells', 'type': 'BIOLOGICAL', 'description': 'Airway Basal Stem Cells', 'armGroupLabels': ['Airway Basal Stem Cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'He', 'role': 'CONTACT', 'email': 'hl@shchildren.com.cn', 'phone': '086-021-52976581'}], 'facility': "Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Liling Qian, Professor and Chief Physician', 'role': 'CONTACT', 'email': 'qianliling@shchildren.com.cn', 'phone': '086-021-62474880'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regend Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Shanghai Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}