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.

CLINICAL RELEVANCE: To the best of our knowledge, this is the first clinical study addressing the use of autologous PL as a treatment measure for knee osteoarthrosis (KOA). There are no studies published regarding the treatment of KOA by intra-articular injections of PL. The previous studies were on the use of platelet-rich plasma (PRP) treatment for KOA. Platelet-rich plasma use has been in place for several years, however, a standardized protocol has not yet been established. Platelet lysate represents a safe, economical, easy to prepare, and easy to apply source of growth factors in the treatment of KOA. A head-to-head study is needed to compare PRP with PL in KOA.