Clinical Trial: Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Multicenter, Randomized, Open-Label, Standard Treatment-Controlled Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells

Brief Summary: This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).