Regenerative medicine company Mesoblast Limited has reported top-line results from the phase II trial of its proprietary Mesenchymal Precursor Cells (MPCs) in subjects with type 2 diabetes. The results of the trial support the safety and tolerability of a single intravenous infusion of MPCs in type 2 diabetes. Additionally, there was an improvement in glycemic control as evidenced by reduction in hemoglobin A1c (HbA1c).
The phase II randomized, single-blind, placebo-controlled, dose escalation trial was conducted across 18 sites in the United States. The trial evaluated the effects of a single intravenous infusion of 0.3, 1.0 or 2.0 million MPCs/kg or placebo over 12 weeks in 61 patients with a mean diabetes duration of 10 years.
Key positive findings were: the MPCs were safe and well tolerated with no treatment-related adverse events, meeting the trial's primary endpoint; following a single intravenous MPC infusion, overall HbA1c levels were reduced over the 12-week study period when compared to placebo; the highest dose showed the greatest overall reduction in HbA1c, with a peak decrease of 0.4% at 8 weeks compared with placebo (p<0.05), and a decrease of 0.3% at 12 weeks; in the less well-controlled subjects, as defined by a baseline HbA1c >8.0%, a 0.6% decrease in HbA1c was seen at 8 weeks in the high dose cohort compared with placebo; in those with baseline HbA1c <8%, a target of HbA1c <7% at week 12 was achieved in 63% (5/8) of high-dose treated subjects compared with 0/7 placebo controls (p<0.05).
Mesoblast chief executive Silviu Itescu said, “We are very pleased and encouraged by these top-line results. In this phase 2 trial, a single injection of Mesoblast’s MPCs was well tolerated and showed evidence of improved glycemic control in type 2 diabetes, a chronic inflammatory disease affecting multiple organs.” “This is an important first step in developing an MPC-based immunomodulatory therapy for the treatment of type 2 diabetes and its complications.”
Mesoblast Limited is a world leader in the development of biologic products for the broad field of regenerative medicine.