NCT00665145

Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509

A Phase 2 Study of Stem-Cell-Mobilization in Subjects With Diabetic Neuropathy Receiving SB-509

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sangamo Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DRUG	SB-509	Active drug
DRUG	SB-509	Active drug
DRUG	Placebo	Placebo
DRUG	SB-509	Active drug

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-04-23
• Last updated: 2012-11-01

Locations

4 sites across 1 country: United States