Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT06998706
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in DLCO from baseline.', 'timeFrame': 'Baseline, 4 weeks post treatment, 24 weeks post treatment', 'description': 'The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.'}], 'secondaryOutcomes': [{'measure': 'Change in FVC from baseline', 'timeFrame': 'Baseline, 4 weeks post treatment, 24 weeks post treatment', 'description': 'The forced vital capacity (FVC) is a measurement of the airflow capacity.'}, {'measure': 'Incidence of adverse events and serious adverse events.', 'timeFrame': 'Through study completion, an average of 6 months'}, {'measure': 'High-resolution CT (HRCT) imaging scores', 'timeFrame': 'Baseline, 4 weeks post treatment, 24 weeks post treatment'}, {'measure': 'Quality of life (QoL) assessment via validated respiratory questionnaires', 'timeFrame': 'Baseline, 4 weeks post treatment, 24 weeks post treatment', 'description': 'Score range: 0 to 100. Higher scores indicate a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Disease (ILD)']}, 'descriptionModule': {'briefSummary': "This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 40-75 years.\n2. Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).\n3. DLCO ≥30% and \\<80% predicted.\n\nExclusion Criteria:\n\n1. Pregnancy, lactation, or plans for pregnancy within 1 year.\n2. Active malignancy or history of malignancy.\n3. Positive serology for HIV, HBV, HCV, or syphilis.'}, 'identificationModule': {'nctId': 'NCT06998706', 'briefTitle': 'REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study', 'orgStudyIdInfo': {'id': '20250515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICD patients', 'interventionNames': ['Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension']}], 'interventions': [{'name': 'REGEND001 Autologous Basal Layer Stem Cell Suspension', 'type': 'BIOLOGICAL', 'description': "REGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5/P63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments.", 'armGroupLabels': ['ICD patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jieming QU', 'investigatorAffiliation': 'Ruijin Hospital'}}}}