Diabetes Care recently published online before print full results from a phase 2 trial of Mesoblast’s mesenchymal precursor cell (MPC) treatment for type 2 diabetes aimed at reducing inflammation. Topline results were released at the end of 2013. The multicenter 12-week, single-blind, dose escalation trial randomized 61 type 2 diabetes patients (mean A1c of 8.3% and diabetes duration of 10 years) to receive a single intravenous infusion of 0.3, 1.0, or 2.0 million MPCs/kg or placebo. After 12 weeks, the MPC treatment produced modest, dose-dependent A1c reductions compared to placebo (0.0%, -0.1%, and -0.3% respectively for the 0.3, 1.0, and 2.0 million MPCs/kg doses). The greatest difference in A1c was seen in the highest dose group at week eight with a 0.4% reduction vs. placebo (P<0.05). At 12 weeks, five (33.3%) subjects in the highest dose group had achieved the <7% A1c target compared to none in the placebo group (P<0.05). As is commonly seen, the treatment seemed to demonstrate greater efficacy in patients with starting A1c ≥8% – a 0.4% reduction in the highest dose group compared to a 0.2% reduction in patients with a starting A1c <8%. There was no observed difference in fasting glucose levels, suggesting this treatment may be targeting postprandial effects. Crucially, the study saw no serious adverse events, serious hypoglycemia, or discontinuations over the 12-week trial period, meeting its primary endpoint. In addition, no immune responses against MPC donor antigens were identified in any subject. We are glad to see these reassuring safety results and look forward to seeing efficacy results from more robust trials in the future. Stem cell treatments are a hot topic in diabetes treatment right now, though most therapies in the pipeline are focused on type 1 diabetes (see Melton group and ViaCyte). Mesoblast is also currently in phase 2 trials investigating MPCs as a diabetic nephropathy treatment.
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