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Positive 2-Year Results Reported for Investigational Low-Back Pain Injections
Positive 24-month results from a phase II program for chronic low-back pain have been presented at the JP Morgan 33rd Annual Healthcare Conference, being held in San Francisco, California.
In a randomized, placebo-controlled, phase II study involving 100 patients with chronic low-back pain due to degenerative disc disease, a single injection of an allogeneic investigational mesenchymal precursor cell (MPC) product, MPC-06-ID (Mesoblast Limited), was well tolerated and was shown to result in substantial improvement in pain and function for at least 24 months.
Highlights of the clinical results include the following:
• A single injection of 6 million MPCs induced substantial and sustained pain relief over 24 months. At 12 and 24 months, 46% and 48% of patients treated with MPC-06-ID achieved minimal or no residual pain (Visual Analog Scale score of 20 or less) compared with 13% of saline-treated patients (P = 0.042 and P = 0.093) , respectively.
• In patients who received a single injection of 6 or 18 million MPCs, 44% and 42%, respectively, achieved the target composite endpoint of treatment success (50% reduction in pain, 15-point improvement in function, and no further treatment intervention) at both 6 and 12 months compared with 13% of saline controls (P = 0.006 and P = 0.020), respectively.
• In patients who received 6 million MPCs and achieved the target composite endpoint of treatment success at both 6 and 12 months, 86% (11 of 13) maintained treatment success at 24 months (32% vs. 11% saline controls; P = 0.001).
More than 4 million individuals in the U.S. have chronic low-back pain. The total costs of low-back pain are estimated to be between $100 billion and $200 billion annually, with two thirds of the costs attributed to patients’ decreased wages and productivity.
Source: Mesoblast Limited; January 15, 2015.