Mesoblast -Model MPC-06-ID -Phase 3 Product for Chronic Discogenic Low Back Pain
MPC-06-ID is a Phase 3 product candidate for the treatment of chronic low back pain caused by disc degeneration (CLBP). It is being developed for patients who have exhausted conservative treatment options, may have failed epidural steroid injections and have no further treatment option other than invasive and costly surgical interventions.
Over four million patients in the United States alone suffer from CLBP1,2,3,4 , which is caused by damage to the disc as a result of aging, genetics, and injuries. This compromises the disc’s capacity to act as a fluid-filled cushion between vertebrae and to provide anatomical stability. Damage also causes an inflammatory response with ingrowth of nerves that result in chronic pain. This combination results in CLBP and functional disability.
When disc degeneration has progressed to a point that pain and loss of function can no longer be managed by conservative means e.g. medication and physiotherapy, major invasive surgery such as spinal fusion is the only remaining option.
Existing therapies treat the symptoms of the disease, but are not disease-modifying and thus do not address the underlying disease cause. As a result, we believe that the most significant unmet need is a therapy that can not only improve the patient’s pain and function, but has the ability to reverse, halt or slow disease progression.
By treating the cause of CLBP, we believe MPC-06-ID could fill an unmet treatment gap for a large population of patients.
MPC-06-ID is a tier 1 product candidate which consists of a unit dose of 6 million mesenchymal precursor cells (MPCs). It is injected by syringe directly into a targeted damaged disc in an outpatient procedure.
Extensive preclinical studies have established that MPCs have anti-inflammatory effects and secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytes in vitro and by resident cells in the nucleus and annulus in vivo. MPCs have also been shown to produce anti-inflammation factors. Together these effects offer the potential to strengthen the load bearing function of the disc by increasing its water content, improving disc anatomy and stability, while also reducing inflammation and pain.