Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-17 @ 11:38 AM
Study NCT ID:
NCT01677520
Status:
UNKNOWN
Last Update Posted:
2015-01-09
First Post:
2012-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Stem Cells in Human Lipoaspirate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009336', 'term': 'Necrosis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Cells from lipoaspirate maximum of 20 days'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-08', 'studyFirstSubmitDate': '2012-08-28', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent of Necrotic ADSCs', 'timeFrame': 'Day of Surgery', 'description': 'Percent of necrotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days of refrigerated storage.'}], 'primaryOutcomes': [{'measure': 'Percent of Viable ADSCs', 'timeFrame': 'Day of Surgery', 'description': 'Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times.'}], 'secondaryOutcomes': [{'measure': 'Percent of Apoptotic ADSCs', 'timeFrame': 'Day of Surgery', 'description': 'Percent of apoptotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days refrigerated storage.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adipose-derived stem cells', 'viable ADSCs', 'apoptosis', 'necrosis', 'cryopreservation'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this study is to enhance identification and isolation of ADSCs and adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts, and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used in aesthetic surgery but tend to disassemble over time. If the investigators can enhance growth and volume of fat in culture, the investigators could use fat grafts in reconstruction of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adults (18-70 yrs) who have scheduled surgical lipectomy of the hips, abdomen, or thighs are prospective subjects for this study.\n\nExclusion Criteria:\n\n* Pregnant women will be excluded to protect the unborn child.'}, 'identificationModule': {'nctId': 'NCT01677520', 'briefTitle': 'Investigation of Stem Cells in Human Lipoaspirate', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Las Vegas'}, 'officialTitle': 'Investigation of Adipose-Derived Stem Cells in Human Lipoaspirate', 'orgStudyIdInfo': {'id': '12.08.004'}}, 'armsInterventionsModule': {'armGroups': [{'label': '18-30 yrs, 31-50 yrs, 51-70 yrs', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William A Zamboni, M.D.', 'role': 'CONTACT', 'email': 'wzamboni@medicine.nevada.edu'}, {'name': 'Karen Zamboni, BSRN', 'role': 'CONTACT', 'email': 'kzamboni@medicine.nevada.edu', 'phone': '702-671-5118'}, {'name': 'William A Zamboni, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Nevada School of Medicine Patient Care Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'centralContacts': [{'name': 'William A Zamboni, M.D.', 'role': 'CONTACT', 'email': 'wzamboni@medicine.nevada.edu', 'phone': '702-671-2278'}, {'name': 'Shelley J Williams, M.S.', 'role': 'CONTACT', 'email': 'sjwilliams@medicine.nevada.edu', 'phone': '702-895-1445'}], 'overallOfficials': [{'name': 'William A Zamboni, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNSOM'}, {'name': 'Wei Z Wang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'wwang@medicine.nevada.edu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair Department of Surgery UNSOM', 'investigatorFullName': 'William A. Zamboni, M.D.', 'investigatorAffiliation': 'University of Nevada, Las Vegas'}}}}