Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 2 Study of Stem-Cell-Mobilization in Subjects With Diabetic Neuropathy Receiving SB-509
The primary and secondary objectives of this study are:
Primary: To evaluate stem-cell-mobilization in subjects with diabetic neuropathy receiving
SB-509. Stem cell mobilization will be assessed by evaluating the presence of stem cells
circulating in peripheral blood.
Secondary: To evaluate the safety of SB-509 in subjects treated with SB-509 with diabetic
neuropathy; and to compare the effect of SB-509 versus placebo on a pre-defined
multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total
neuropathy score (TNS), evoked nerve conduction velocity (NCV) and quantitative sensory
testing (QST)
SB-509 contains the gene (DNA—a kind of biological "blueprint") for a protein. When a
researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around
the injection site and causes these cells to make a protein. This protein causes your cells
to increase production of another protein called vascular endothelial growth factor (VEGF),
which may improve the structure and function of nerves. In addition, there are changes in
the levels of 28 additional proteins in your cells. These proteins function to promote the
growth of cells, are structures in cells, help synthesize products, and affect immune cells,
and some have unknown functions. This increase in your own VEGF proteins may protect and
repair the damaged nerves caused by diabetic neuropathy.
This study is intended to further evaluate the mechanism of SB-509 action.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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