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Type 2 diabetes and its complications are considered to have an underlying immunological component associated with excessive pro-inflammatory cytokines. The immunomodulatory properties of Mesoblast’s Mesenchymal Precursor Cells (MPCs) provided the rationale for conducting the study.The study investigators concluded there was sufficient evidence to support further evaluation into the use of MPCs in type 2 diabetes and its complications, and to explore further the effects of MPCs on disease mechanisms.
Type 2 Diabetes Trial Using Mesoblast’s Proprietary Adult Stem Cells Yields Positive Results
MELBOURNE, Australia, June 18, 2014 – Results from the Phase 2 trial of Mesoblast’s proprietary adult stem cells in type 2 diabetes patients have been presented at the scientific sessions of the American Diabetes Association annual meeting.
Type 2 diabetes and its complications are considered to have an underlying immunological component associated with excessive pro-inflammatory cytokines.
The immunomodulatory properties of Mesoblast’s Mesenchymal Precursor Cells (MPCs) provided the rationale for conducting the study.
The Phase 2 randomized, single-blind, placebo-controlled, dose escalation trial was conducted across 18 U.S. sites. 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 who were inadequately controlled on metformin alone or with one other glucose-lowering agent. Mean diabetes duration was 10 years.
The key findings from the study:
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There were no safety issues and the cell infusions were well tolerated (with a maximal dose of 246 million cells).
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There was a dose-dependent improvement in glycemic control as evidenced by a decrease at all timepoints after week 1 in hemoglobin A1c (HbA1c) in MPC-treated patients compared with an increase in HbA1c in placebo treated subjects.
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A significant reduction in HbA1c was seen after 8 weeks in the 2 M/kg MPC group compared to placebo (p less than 0.05) which was sustained through 12 weeks.
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The reduction in HbA1c was most pronounced in subjects with baseline HbA1c greater or equal to 8 percent (i.e. those patients with relatively poorer glucose control).
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Fasting insulin levels were reduced in the 1M and 2M/kg groups compared to placebo (P less than 0.05).
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Reduced levels of inflammatory cytokines TNF-alpha and IL-6 were observed at 12 weeks in MPC groups compared to placebo.
The study investigators concluded there was sufficient evidence to support further evaluation into the use of MPCs in type 2 diabetes and its complications, and to explore further the effects of MPCs on disease mechanisms.