Active — Not RecruitingPhase 4

Application of Autologous Stem Cells From Adipose Tissue in the Regeneration of Knee Joint Cartilage

Serbia60 participantsStarted 2025-06-25

Plain-language summary

This randomized, controlled clinical trial will evaluate the safety and effectiveness of autologous adipose-derived stromal vascular fraction (SVF) therapy in patients with knee osteoarthritis (OA) grades II-IV, compared with standard chondroprotective (CP) treatment. The study will enroll male and female patients and follow them for 12 months, assessing pain (VAS), function (WOMAC, KOOS, SF-36), radiologic progression, and safety (adverse events). The trial aims to determine whether SVF therapy provides superior clinical outcomes and to inform evidence-based recommendations for OA management in the Serbian population.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (≥18 years). * Radiologically confirmed knee OA (grades II-IV, Kellgren-Lawrence scale). * KOOS pain score ≤ 60 points. * Symptomatic degenerative knee disease with at least 6 months of persistent pain. * No history of major knee trauma or prolonged immobilization (\>10 days) Exclusion Criteria: * Minors (\<18 years). * Asymptomatic OA (KL grade 0-I). * Severe axial deformity (varus \>10°, valgus \>10°). * Current anticoagulant or antiplatelet therapy. * Intra-articular corticosteroid injection within the past 6 months. * History of major knee trauma or surgery.

What they're measuring

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Timeframe: Baseline, 3 6 and 12 months post-treatment.

Trial details

NCT IDNCT07405840

SponsorClinical Center of Vojvodina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

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