BMAC for Osteoarthritis (BMAC Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: University of California, San Diego

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.

Eligibility Criteria

This trial is for men and women aged 45-75 with moderate to severe knee osteoarthritis, who have persistent pain despite standard treatments like acetaminophen, NSAIDs, physical therapy, or injections. They should need a total knee arthroscopy as determined by their primary care provider or orthopedist.

Treatment Details

The study is testing the safety and effectiveness of Bone Marrow Aspirate Concentrate (BMAC) using the Angel System to treat knee osteoarthritis. BMAC contains stem cells that may help preserve or improve joint structure.

1Treatment groups

Experimental Treatment

Group I: Bone marrow aspiration concentrate using the Angel SystemExperimental Treatment2 Interventions

Bone marrow aspirate concentrate (BMAC) will be administered via injection to the knee of interest on day 14 of the study. Bone marrow aspiration will be concentrated using the Angel System.