Sicurezza/efficacia della terapia con cellule staminali mesenchimali hUC（19#iSCLife®-OA） per pazienti affetti da osteoartrite
This is a random, etichetta aperta, ed esperimento controllato in parallelo. Tutti i pazienti vengono selezionati e firmano i moduli di consenso, poi diviso in 3 gruppi. I medici raccolgono le informazioni di base del paziente. All patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 settimane, 1, 2, 3, 6, E 12 months after treatment, and do safety and efficacy evaluation.
Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, velocità di sedimentazione eritrocitaria, and tumor marker, eccetera.
Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (VAS) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (MRI) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.
