Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-29 @ 8:02 PM
Study NCT ID:
NCT04896567
Status:
WITHDRAWN
Last Update Posted:
2022-08-03
First Post:
2018-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002469', 'term': 'Cell Separation'}], 'ancestors': [{'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Consecutive patients will be consented to obtain kidney biopsy material.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Superseded by a separate study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-31', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cell growth', 'timeFrame': '1 week', 'description': 'Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled.'}], 'secondaryOutcomes': [{'measure': 'Kidney disease progression', 'timeFrame': '3 years', 'description': 'Isolated cell growth will be compared to serum creatinine of patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Diseases', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.', 'detailedDescription': 'Endothelial dysfunction is central to the pathophysiology of vascular ischemia, bacterial sepsis, toxin-induced thrombotic microangiopathy, and antibody-mediated kidney transplant rejection and often manifest with renal failure. With each of these diagnoses circulating components of the complement cascade bind to endothelial cells and induce disease progression through anaphylactic cellular messaging, monocyte homing, and direct cell membrane disruption. In response to injury during embryologic development avascular metanephric blastema initiate endothelial differentiation. Although circulating hematopoietic progenitor cells have shown therapeutic promise they incorporate into renal vasculature at very low density.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only patients who have a clinical indication for kidney biopsy will be considered.\n* All subjects will be at least 18 years of age and may be of any gender.\n* Patients undergoing a native or kidney transplant biopsy will be considered.\n\nExclusion Criteria:\n\n* Patients not undergoing a kidney biopsy will be excluded.'}, 'identificationModule': {'nctId': 'NCT04896567', 'briefTitle': 'Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair', 'orgStudyIdInfo': {'id': 'awaiting IRB approval'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients will have kidney biopsy designated for cell isolation and culture.', 'interventionNames': ['Diagnostic Test: Cell isolation']}], 'interventions': [{'name': 'Cell isolation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Andrew Michael Siedlecki', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}