Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02732106
Status:
UNKNOWN
Last Update Posted:
2016-04-11
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2016-04-04', 'lastUpdatePostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adipose-Derived Regenerative Cells (ADRCs)- Cell Characterization', 'timeFrame': 'Day 1', 'description': 'Cells will be evaluated regarding cell composition by flow cytometric assays.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADRCs, cell characterization'], 'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'Human adipose tissue is now recognized as an acceptable, highly abundant source of adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and vessel-associated cells. Autologous adult regenerative cells are thought to promote healing of scarred or injured tissue. While the investigators are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. The use of ADRCs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in numerous clinical and preclinical studies around the world. While there is a considerable amount of information regarding the cellular composition of ADRCs isolated from healthy donors, basically there is no much data regarding the ADRC composition from cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia patients, that would otherwise be thrown away in waste, will be provided to researchers who will study these cells with the objective to characterize ADRCs derived from patients with a heart disease and to compare if a heart disease state does impact ADRC cell composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic heart disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients enrolled in the ATHENA clinical trial that donated their leftover material to be studied.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02732106', 'briefTitle': 'Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytori Therapeutics'}, 'officialTitle': 'Characterization of Adipose Derived Regenerative Cells (ADRCs) From Excess Tissue and Cells Designated for Discard From Patients With Chronic Heart Disease', 'orgStudyIdInfo': {'id': 'CYTX-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic - Torrey Pines, Scripps Green Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Heart Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Steven Kesten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cytori Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytori Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}