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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
23
Unnamed facility
La Jolla, California, United States
Unnamed facility
Walnut Creek, California, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
San Antonio, Texas, United States
Stem cells circulating in peripheral blood
Time frame: One year
Safety and Efficacy of SB-509
Time frame: One year
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