drugset / Trial / NCT07259993
Knee Osteoarthritis With Stromal Vascular Fraction Cells
Phase 1/2
Completed
16 enrolled
Michael H Carstens
Hospital Vivian Pellas, Nicaragua · collabMinistry of Health Nicaragua · collabUniversity of California, San Francisco · collabWake Forest University · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2013-08-27
- Primary completion
- 2025-07-26
- Completion
- 2025-10-30
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | autologous adipose tissue-derived stromal vascular fraction cells | Cell therapy | 55.5 cells | Other |