Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis
brief summary
The goal of this Phase II/III, double-blinded, multicenter clinical trial is to assess the clinical efficacy of autologous peripheral blood mononuclear cells (PBMCs) in the management of knee osteoarthritis (KOA). The main questions it aims to answer are: 1. To determine the safety of the PCP-PBMCs injection 2. To compare the long-term efficacy between PCP-PBMCs and methylprednisolone on pain relief and motor function restoration 3. To analyze improving quality of life after the PCP-PBMCs treatment.
detailed description
240 patients from both genders diagnosed with knee osteoarthritis, will be enrolled according to inclusion and exclusion criteria. These patients will be randomly injected with 100-200 million PBMCs, 20-60 million PBMCs or methylpredinisolone. They are then followed by clinical assessment, laboratory investigations as well as X-ray imaging of the injected knee.
official title
Peripheral-blood Cell Purification for PBMCs (PCP-PBMCs) Injection for Knee Osteoarthritis (PCP-PBMCs-KOA)