The FDA Office of Tissues and Advanced Therapies granted Regenerative Medicine Advanced Therapy (RMAT) Designation to rexlemestrocel-L (Mesoblast Ltd.) for the treatment of chronic low back pain (LBP) associated with disk degeneration, in combination with hyaluronic acid (HA) as a delivery agent for injection into the lumbar disk.
“There is a significant need for a safe, effective, and durable opioid-sparing treatment in patients with chronic LBP associated with degenerative disc