Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT07259993
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Knee Osteoarthritis With Stromal Vascular Fraction Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment related adverse events', 'timeFrame': '6 months follow-up post intervention', 'description': 'Documentation of adverse events'}, {'measure': 'Osteoarthritis outcome score (KOOS)', 'timeFrame': 'Up to 10 years follow-up post SVF treatment', 'description': 'Changes in KOOS scores'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '28148295', 'type': 'BACKGROUND', 'citation': 'Mathiessen A, Conaghan PG. Synovitis in osteoarthritis: current understanding with therapeutic implications. Arthritis Res Ther. 2017 Feb 2;19(1):18. doi: 10.1186/s13075-017-1229-9.'}, {'pmid': '32722615', 'type': 'BACKGROUND', 'citation': 'Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.'}, {'pmid': '37678972', 'type': 'BACKGROUND', 'citation': 'Gao F, Mao X, Wu X. Mesenchymal stem cells in osteoarthritis: The need for translation into clinical therapy. Prog Mol Biol Transl Sci. 2023;199:199-225. doi: 10.1016/bs.pmbts.2023.02.006. Epub 2023 Mar 16.'}, {'pmid': '36545894', 'type': 'BACKGROUND', 'citation': 'Carstens MH, Garcia N, Mandayam S, Workeneh B, Pastora I, Calderon C, Bertram KA, Correa D. Safety of Stromal Vascular Fraction Cell Therapy for Chronic Kidney Disease of Unknown Cause (Mesoamerican Nephropathy). Stem Cells Transl Med. 2023 Jan 30;12(1):7-16. doi: 10.1093/stcltm/szac080.'}, {'pmid': '26238455', 'type': 'BACKGROUND', 'citation': 'Fodor PB, Paulseth SG. Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Aesthet Surg J. 2016 Feb;36(2):229-36. doi: 10.1093/asj/sjv135. Epub 2015 Aug 3.'}, {'pmid': '39658493', 'type': 'BACKGROUND', 'citation': "Carstens M, Martinez-Cerrato J, Garcia L, Rivera B, Bertram K. Safety of adipose-derived stromal vascular fraction cells to treat Parkinson's disease. Parkinsonism Relat Disord. 2025 Mar;132:107214. doi: 10.1016/j.parkreldis.2024.107214. Epub 2024 Nov 28."}]}, 'descriptionModule': {'briefSummary': 'This is an interventional study to treat knees osteoarthritis (KOA) with adipose-derived stromal vascular fraction cell components in sixteen subjects with either unilateral or bilateral symptomatic Kellgren Lawence Grade 3 KOA by intra-articular injection of knees. Later, subjects were followed for safety out and potential benefits.', 'detailedDescription': 'A prospective, open-label interventional study was conducted to assess safety and evidence of clinical response to administration of intra-articular SVF in 16 patients with symptomatic, radiographic Kellgren Lawence grade 3 KOA. Approximately 55.5 million SVF cells were administered via intra-articular injection into each of the 29 knees; asymptomatic knees remained untreated. Subjects were followed for safety out to six months. Potential benefit was measured using the Knee Injury Osteoarthritis Outcome Scores (KOOS) at baseline (pre-treatment), at 3- and 6-months post-treatment, and then subsequently at 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiologically documented Kellgren Lawence grade 3 (moderate) KOA;\n* Knee pain rated greater than 4/10 on the linear pain scale;\n* Previous treatment history with anti-inflammatory medications or corticosteroid injections\n\nExclusion Criteria:\n\n* Corticosteroid injection within 3 months prior to SVF treatment\n* Taking anticoagulants prior to SVF treatment'}, 'identificationModule': {'nctId': 'NCT07259993', 'briefTitle': 'Knee Osteoarthritis With Stromal Vascular Fraction Cells', 'organization': {'class': 'OTHER', 'fullName': 'Michael H Carstens'}, 'officialTitle': 'Treatment of Knee Osteoarthritis With Stromal Vascular Fraction Cells: 10-Years Follow-up', 'orgStudyIdInfo': {'id': 'MS-DGRS-MABJ-7536-11-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SVF cells treatment', 'description': 'Intra-articular injection of SVF cells in the injured knee.', 'interventionNames': ['Biological: autologous adipose tissue-derived stromal vascular fraction cells']}], 'interventions': [{'name': 'autologous adipose tissue-derived stromal vascular fraction cells', 'type': 'BIOLOGICAL', 'otherNames': ['SVF'], 'description': 'SVF cells via intra-articular injection into knees', 'armGroupLabels': ['SVF cells treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'León', 'country': 'Nicaragua', 'facility': 'Hospital Escuela Oscar Danilo Rosales Arguello', 'geoPoint': {'lat': 12.43527, 'lon': -86.87862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael H Carstens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wake Forest University', 'class': 'OTHER'}, {'name': 'Ministry of Health Nicaragua', 'class': 'UNKNOWN'}, {'name': 'Hospital Vivian Pellas, Nicaragua', 'class': 'UNKNOWN'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}