Stromal Vascular Fraction (SVF) for Knee Post-Trauma Osteoarthritis (PTOA)
Stopped: Lack of Funding
United States0Started 2026-02
Plain-language summary
This is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA).
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Males and females 18 - 45 with a preceding history (\>1 and \< 20 years ago) of significant knee trauma or trauma- related knee surgery
* Post-Trauma Osteoarthritis (PTOA) as diagnosed by K-L Grade II or III OA (weight bearing X-ray) and physician review
* Subjects must present with symptomatic (injured knee) visual analog scale (VAS) pain \> 4. If bilateral disease, Knee Osteoarthritis (KOA) pain in the other knee must be less than/equal to 3 on the VAS for pain
* Subjects must have an adjusted Western Ontario and McMaster Universities Arthritis Index (WOMAC) (100-point scale) of \> 25 and \<90
* Study Subjects must have continued knee pain despite at least two conservative prescribed therapies (pain medications, physical therapy, knee injections, or weight loss), spanning a period of at least 3 months
* Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed
* Subjects will be in good health (ASA Class I-II) with a Body mass index (BMI) \< 35
* Subjects must speak, read, and understand English
* Subjects must be reasonably able to return for multiple follow-up visits, to include procedure visits
Exclusion Criteria:
* Subjects whose knee pain is caused by, (i) diffuse edema, (ii) cartilage lesion greater than 1 cm width and grade 4 depth by MRI or (iii) osteochondritis disseca…