9 February 2023 - Mesoblast today announced that the US FDA's Office of Tissues and Advanced Therapies has granted regenerative medicine advanced therapy designation for rexlemestrocel-L in the treatment of chronic low back pain associated with disc degeneration, in combination with hyaluronic acid as delivery agent for injection into the lumbar disc.

Data from the completed 404 patient randomised, blinded placebo-controlled Phase 3 trial of rexlemestrocel-L combined with hyaluronic acid formed the basis for FDA’s determination that Mesoblast’s allogeneic cell therapy has the potential to address unmet medical needs for patients suffering from chronic low back pain due to disc degeneration.

Read Mesoblast press release