Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:00 PM
Study NCT ID:
NCT04503161
Status:
WITHDRAWN
Last Update Posted:
2022-08-29
First Post:
2020-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002558', 'term': 'Cerebrospinal Fluid Otorrhea'}], 'ancestors': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Investigator left institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of CSF leak', 'timeFrame': '6 months active participation (date of surgery + 6 months follow up via chart review)'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '6 months active participation (date of surgery + 6 months follow up via chart review)'}, {'measure': 'Need for reoperation', 'timeFrame': '6 months active participation (date of surgery + 6 months follow up via chart review)'}, {'measure': 'Postoperative hematoma', 'timeFrame': '6 months active participation (date of surgery + 6 months follow up via chart review)'}, {'measure': 'Postoperative infection', 'timeFrame': '6 months active participation (date of surgery + 6 months follow up via chart review)'}, {'measure': 'Need for rehospitalization', 'timeFrame': '6 months active participation (date of surgery + 6 months follow up via chart review)'}, {'measure': 'Death', 'timeFrame': '6 months active participation (date of surgery + 6 months follow up via chart review)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['CSF Leak']}, 'descriptionModule': {'briefSummary': 'This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF) mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>/= 18\n* Planned for skull base surgery\n* Able to understand and willing to sign a written informed consent form\n\nExclusion Criteria:\n\n* active skull base infection\n* no plan for DuraGen repair by operating surgeon'}, 'identificationModule': {'nctId': 'NCT04503161', 'briefTitle': 'The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery', 'orgStudyIdInfo': {'id': 'IRB-52778'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrogel recipient', 'interventionNames': ['Device: Duragen with Collagen Hydrodel and ASCs']}], 'interventions': [{'name': 'Duragen with Collagen Hydrodel and ASCs', 'type': 'DEVICE', 'description': "Duragen combined with collagen hydrogel and patient's stem cells", 'armGroupLabels': ['Hydrogel recipient']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}