Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial
The MAST-GR study is a randomized controlled interventional trial with parallel treatment arms and 1:1 allocation The primary objective of the study is to compare the safety and efficacy of a single intra-articular infiltration of Bone marrow aspirate concentrate (BMAC) with one of minimally manipulated adipose tissue (MM-AT) so as to determine the most effective cellular product in treating patients with knee osteoarthritis (OA). The secondary objective is to demonstrate whether intra-articular infiltration of BMAC or MM-AT can induce disease-modifying effects in knee OA by imaging and biological assessments on peripheral blood. The tertiary objective of the study is to identify factors that influence the clinical response to treatment (baseline characteristics of patients, biological characteristics of the treated knee, characteristics of cellular products, BMAC and MM-AT).
⁃ Patients with symptomatic unilateral knee OA with:
• Men or women aged 40 to 75 years;
• Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months;
• Radiographic signs of OA (Kellgren-Lawrence grade 1-4);
• No benefit after at least 4 months of conservative treatment;
• Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up;
• Signing of informed consent.