Mesoblast Cell Therapy Gets RMAT Designation for Chronic Low Back Pain

The FDA has granted regenerative medicine advanced therapy (RMAT) designation for Mesoblast’s rexlemestrocel-L in the treatment of chronic low back pain associated with disc degeneration, in combination with hyaluronic acid as a delivery agent for injection into the lumbar disc.

The designation for the allogeneic cell therapy was based on data from a phase 3 trial of 404 patients showing that a single injection of rexlemestrocel-L into the lumbar disc resulted in significant reduction in pain compared with saline control at 12 and 24 months across all subjects.

Low back pain is the fifth most common reason for visiting a U.S. doctor and is one of the leading causes of disability. An effective new treatment for the condition could reduce the amount of opioids currently prescribed for it.

RMAT designations aim to expedite the development of regenerative medicine therapies intended to treat a serious condition when preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs. The designation includes eligibility for priority review on filing of a biologics license application.