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| Name | Class |
|---|---|
| Wake Forest University | OTHER |
| Ministry of Health Nicaragua | UNKNOWN |
| Hospital Vivian Pellas, Nicaragua | UNKNOWN |
| University of California, San Francisco |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVF cells treatment | Experimental | Intra-articular injection of SVF cells in the injured knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous adipose tissue-derived stromal vascular fraction cells | Biological | SVF cells via intra-articular injection into knees |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment related adverse events | Documentation of adverse events | 6 months follow-up post intervention |
| Osteoarthritis outcome score (KOOS) | Changes in KOOS scores | Up to 10 years follow-up post SVF treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Escuela Oscar Danilo Rosales Arguello | León | Nicaragua |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28148295 | Background | 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. | |
| 32722615 | Background | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| OTHER |
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| 37678972 | Background | 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. |
| 36545894 | Background | 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. |
| 26238455 | Background | 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. |
| 39658493 | Background | 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. |
| D012216 |
| Rheumatic Diseases |