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Sponsored by: |
Sangamo Biosciences |
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Information provided by: | Sangamo Biosciences |
ClinicalTrials.gov Identifier: | NCT00665145 |
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)
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Polyneuropathy |
Drug: SB-509 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study of Stem-Cell-Mobilization in Subjects With Diabetic Neuropathy Receiving SB-509 |
Estimated Enrollment: | 20 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cohort 1
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Drug: SB-509
Active drug
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2: Experimental
Cohort 2
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Drug: SB-509
Active drug
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3: Placebo Comparator
Cohort 3
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Drug: Placebo
Placebo
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4: Experimental
Cohort 4
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Drug: SB-509
Active drug
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects with the following are NOT eligible to participate in this study:
United States, California | |
Coordinated Clinical Research | |
La Jolla,, California, United States, 92037 | |
Diablo Clinical Research | |
Walnut Creek, California, United States, 94598 | |
United States, Texas | |
DGD Research | |
San Antonio, Texas, United States, 78229 | |
Nerve and Muscle Center of Texas | |
Houston, Texas, United States, 77030 |
Responsible Party: | Sangamo BioSciences, Inc. ( Ely Benaim, M.D., Vice President, Clinical Affairs ) |
Study ID Numbers: | SB-509-0703 |
Study First Received: | April 21, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00665145 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Polyneuropathy Stem Cells |
Metabolic Diseases Autoimmune Diseases Diabetic Neuropathies Polyneuropathies Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus Type 1 Diabetes Mellitus, Type 1 |
Neuromuscular Diseases Peripheral Nervous System Diseases Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Diabetes Complications |
Metabolic Diseases Autoimmune Diseases Diabetic Neuropathies Immune System Diseases Nervous System Diseases Diabetes Mellitus Polyneuropathies |
Endocrine System Diseases Diabetes Mellitus, Type 1 Neuromuscular Diseases Peripheral Nervous System Diseases Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Diabetes Complications |