Adult stem cells: Phase II data

A U.S. and Australian Phase II trial in 100 patients with chronic moderate to severe lower back pain showed that a single intra-disc injection with 6 or 18 million MPCs each reduced mean VAS scores from baseline to 12 months vs. controls. Specifically, mean VAS scores were reduced by 37 points at the low-dose of MPCs and by 40 points at the high-dose of MPCs vs. 27 points for saline-treated controls and 27 points for hyaluronic acid (HA)-treated controls (p=0.11 and p=0.046, respectively, vs. pooled controls). A significantly greater proportion of patients receiving MPCs achieved a >50% reduction in pain score from baseline to 12 months at the low-dose (69%) and high-dose (62%) vs. saline (31%) and HA (35%) controls (p=0.009 and p=0.038, respectively, vs. pooled controls). Additionally, a significantly greater proportion of patients receiving MPCs achieved minimal residual back pain, defined as a VAS score of <20 points, at 12 months at the low-dose (52%) and high-dose (42%) vs. pooled controls (18%) (p=0.01 and p=0.05, respectively, vs. pooled controls). At 12 months, mean daily opioid use was 0.77 tablets with low-dose MPCs, 0.58 tablets with high-dose MPCs, 1 tablet with saline and 0.94 tablets with HA. ...