Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT01885832
Status:
WITHDRAWN
Last Update Posted:
2017-08-10
First Post:
2013-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'per sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Kellgren-Lawrence classification at 6 months', 'timeFrame': '6 months'}, {'measure': 'Change from baseline WOMAC Assessment at 6 months', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['autologous adipose stem cells', 'stromal vascular fraction', 'osteoarthritis'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity will be safe and feasible as assessed by lack of treatment associated adverse events. Improvements in joint function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) are anticipated.', 'detailedDescription': 'The proposed study is a single center, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) isolated from 500 ml of adipose tissue extracted from the infraumbilical area. The cellular product will be administered via intra-articular injection into patients with moderate to severe osteoarthritis (OA). Administration will be performed by injection into the synovial space. The dosing regimen will consist of two intraarticular injection of autologous SVF into the index knee. Total injection volume will be about 30 mL in two 15 mL aliquots via a 23 gauge needle inserted 1.5 cm. deep into the intraauricular space of the knee. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).\n\nThe purpose of this study will be to define the safety and efficacy of SVF therapy in improving joint function and the quality of life in patients with OA of the knee. We plan to enroll twenty subjects for treatment for an adequate sample size for safety analysis with signals of efficacy. The primary safety outcome will be tabulation of adverse events related to treatment. Efficacy will be quantified at 3, 6 and 12 months by the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\>18 years and ability to understand the planned treatment.\n\nIdiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification\n\nAbility and willingness to undergo liposuction\n\nExclusion Criteria:\n\nPregnant women or cognitively impaired adults.\n\nPresence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.\n\nInflammatory or postinfectious arthritis.\n\nMore than 5 degrees of varus or valgus deformity.\n\nKellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.\n\nIntraarticular corticosteroid injection within the previous 3 months.\n\nA major neurologic deficit.\n\nSerious medical illness with a life expectancy of less than 1 year.\n\nPrior admission for substance abuse\n\nBody Mass Index (BMI) of 40 kg/m2 or greater\n\nPatient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent\n\nIn the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01885832', 'briefTitle': 'Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Translational Biosciences'}, 'officialTitle': 'Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis', 'orgStudyIdInfo': {'id': 'TBS-SVF-OA-002-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'In the treatment arm, autologous stromal vascular fraction (SVF) will be injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity.', 'interventionNames': ['Biological: Autologous adipose tissue stromal vascular fraction']}], 'interventions': [{'name': 'Autologous adipose tissue stromal vascular fraction', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'country': 'Panama', 'facility': 'Stem Cell Instsitute', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Jorge Paz-Rodriguez, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stem Cell Institute Panama'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translational Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}