Effects of intra‑articular injection of stromal vascular fraction and adipose‑derived mesenchymal stem cells in patients with moderate‑to‑severe knee pain.

Prospective, preliminary, observational study based on clinical data collected during standard care, aimed at evaluating the effect of Adipose Delivered Mesenchymal Stem Cells (ADMSC) and Stromal Vascular Component in patients with knee osteoarthritis. Since the introduction of the ADMSC harvesting and injection procedure in our hospital, all patients undergo the same follow-up schedule, with clinical assessments at baseline (day 0), 180 days, and 365 days. At each visit, the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire and the Numerical Rating Scale (NRS) for pain will be administered. Cartilage thickness will be measured by ultrasound at baseline and at 365 days. A total of 50 consecutive patients will be enrolled over 18 months. The study was approved by the local Ethics Committee (Regione Umbria Regional Ethics Committee, approval No. 07032025, 16 April 2025).