START Trial: Randomized, controlled, open and parellel trial to evaluate the efficiency and safety of intra-articular infiltration of Autologous Bone Marrow Concentrate (BMC) or Mesenchymal Stem Cell (MSC) associated with Platelet Rich Plasma (PRP) in patients with primary knee osteoarthritis

INTERVENTION: Biological/vaccine Bone marrow donor Drug Other joint disorders Procedure/surgery The 256 study participants may be men or women, aged 49 to 75 years (inclusive) who have a diagnosis of knee osteoarthritis and pain. Participants will be randomly assigned to one of the following groups: Group 1 (Control): 64 individuals who will receive a single intra ‐ articular infiltration of hyaluronic acid (Synvisc One ‐ 6mL) and follow ‐ up periods of 12 months. Group 2 (Experimental ‐ PRP): 64 individuals will be collected 15 ml of blood and processed in the laboratory to form the substance called platelet‐rich plasma (PRP). This concentrate will be injected into the knee with pain, in three applications with intervals of one week between each, in addition to a follow‐up period of 12 months. Group 3 (Experimental ‐ CTM + PRP): 64 individuals will be performed collecting approximately 100 mL of cells from within the basin bone. For this procedure the doctor will do a local anesthetic. The collected material will go to a sanitary surveillance laboratory, with all the necessary quality controls for the safety of this handling process, and after about 15 days this product will be injected into your knee with pain. In this group, 15 ml of blood will also be collected and processed in the laboratory to form the substance called platelet rich plasma. In the first application, cells and platelets will be injected, followed by two more applications of platelet rich plasma, with a one‐week interval between each application, in addition to a follow‐up period of 12 months. Group 4 (Experimental ‐ CMO + PRP): 64 individuals will be performed collecting approximately 100 mL of cells from within the basin bone. For this procedure the doctor will do a local anesthetic. The collected material will go to a laboratory certified by sanitary surveillance for processing (approximately 2 hours). The next day this concentrate will be injected into your knee with pain. In this group, 15 ml of blood will also be collected and processed in the laborato CONDITION: Gonarthrosis [arthrosis of knee] Gonarthrosis [Arthrosis of knee]; Pain in joint ; Gonarthrosis [arthrosis of knee] ; Pain in joint M00‐M99 Pain in joint PRIMARY OUTCOME: Evaluate pain, stiffness, level of physical activity, development of knee osteoarthritis and the efficacy of the investigacional products in the participants of all study groups. SECONDARY OUTCOME: To assess the safety of intra‐articular use of the products under investigation by analyzing the rates of occurrence of serious and non‐serious adverse events in participants in all groups of the study. INCLUSION CRITERIA: Adults with age in between 49 and 75 years old; Clinical and radiological diagnosis of primary knee osteoarthritis with lesion of mild to moderate intensity (II and III) based on the classification criteria of the American College of Rheumatology (Altman et al., 1986) with radiological confirmation following a Kellgren and Laurence scale (1957); History of knee edema, pain, stiffness, gait alteration and loss of movement due to the degenerative joint process; Availability of follow‐up during the study period; Have provided written voluntary consent to participate in the study, confirmed by the signature of Informed Consent Form.