Phase 3 Trial For Chronic Low Back Pain Completes Enrollment.
MELBOURNE, Australia, March 28, 2018 -- Mesoblast Limited (MESO) announced that enrollment is complete in its Phase 3 trial evaluating a single intra-discal injection of its proprietary allogeneic mesenchymal precursor cell (MPC) product candidate MPC-06-ID in patients with chronic low back pain due to degenerative disc disease.
MPC-06-ID is being evaluated to determine whether it can alleviate pain and improve function in patients who do not receive adequate relief from current standard of care therapies such as non-steroidal anti-inflammatory drugs, epidural steroid injections or opioids.
The 2:1 randomized, placebo-controlled Phase 3 trial (NCT02412735) enrolled 404 patients across 48 centers in the U.S. and Australia.
Following completion of the 360 patients, all additional patients still in screening at that point were allowed to enroll.
The Phase 3 trial's primary endpoint complies with written guidance from the FDA in support of product registration and specifies use of a composite measurement showing significant clinical improvement in pain and function at both 12 and 24 months.
Phase 2 results in 100 patients showed that a single intra-discal injection of MPC-06-ID alleviated pain and improved function for up to three years in patients whose symptoms were not adequately treated with current standard of care therapies.
More than 33 million people in the U.S. suffer from CLBP with approximately 22 percent caused by degenerative disc disease.
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|Title Annotation:||Clinical Trials|
|Publication:||Stem Cell Business News|
|Date:||Apr 2, 2018|
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