Study of Bone Marrow Aspirate Concentrate BMAC Treatment Using the Angel System for Moderate to Severe Knee Osteoarthritis in Adults Aged 45 to 75

What this Trial Is About

This research aims to study the safety and potential effectiveness of bone marrow aspirate concentrate BMAC for patients with moderate to severe osteoarthritis of the knee. BMAC is a stem cell-based therapy that provides a rich source of mesenchymal stem cells MSCs and may help preserve or improve joint structure. The study uses the Angel System device to concentrate bone marrow and collect plasma-rich platelets before surgery. Patients who need total knee replacement will have bone marrow taken from their pelvic region several weeks before surgery. This marrow is concentrated using the Arthrex Angel Concentrated Platelet Rich Plasma cPRP System and then injected arthroscopically into the affected knee. This is a pilot, open-label, non-randomized study conducted at a single institution. Blood and tissue samples will be collected for detailed analysis, and adverse events will be monitored. Participants will undergo physical exams and complete standardized health questionnaires to assess healing and health status. The primary outcome measures include monitoring for severe adverse events over 12 months. Secondary outcomes involve measuring structural knee changes using pain and function scales such as the Visual Analog Scale VAS and American College of RheumatologyKnee Osteoarthritis Assessment Scale ACRKOAS, along with self-reported health surveys. The total study duration for each participant is 12 months.

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis