Safety and Efficacy of Autologous Intra-articular Platelet Lysates in Early and Intermediate Knee Osteoarthrosis in Humans: A Prospective Open-Label Study

Objective: To explore the safety and benefit from intra-articular autologous platelet lysate (PL) injection in early and intermediate knee osteoarthritis. Design: Open-label prospective study. Setting: Laboratory. Patients: Adult patients, aged 35 to 70 years, with a history of chronic pain or swelling on one or both knees and imaging findings (radiograph or magnetic resonance imaging) of degenerative changes in the joint of grade I or II on the Kellgren scale were included. Interventions: Autologous PL was given in the knee joint by percutaneous intra-articular route every 3 weeks for a total of 3 injections. Main Outcome Measures: Response was evaluated by nonnormalized Knee Osteoarthritis and Disability Outcome Score (KOOS). Results:There was a significant improvement in the 5 aspects evaluated at weeks 32 and 52 compared with baseline. Symptoms score significantly improved at weeks 32 and 52 from a mean of 11.1 at baseline to 9.0 (P < 0.0001) and 8.7 (P < 0.0001). Stiffness score significantly improved at weeks 32 and 52 from 2.2 at baseline to 1.7 (P < 0.022) and 1.6 (P < 0.016). Pain score improved at 32 weeks and at 52 weeks from a baseline of 14.2 to 9.8 (P < 0.0001) and 9.2 (P < 0.0001). Daily Living score improved from 25.0 to 18.7 at 32 weeks (P < 0.0001) and to 15.6 at 52 weeks (P < 0.0001). Sport score improved from 10.7 to 8.4 at 32 weeks (P < 0.0001) and to 8.1 at 52 weeks (P < 0.0001). Conclusions:Intra-articular PL significantly improved score of all aspects evaluated by KOOS. Platelet lysate seems to be a safe product.