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Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509
This study is ongoing, but not recruiting participants.
Sponsored by: Sangamo Biosciences
Information provided by: Sangamo Biosciences
ClinicalTrials.gov Identifier: NCT00665145
  Purpose

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
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Polyneuropathy
Drug: SB-509
Drug: Placebo
Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetic Nerve Problems
U.S. FDA Resources
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

Further study details as provided by Sangamo Biosciences:

Primary Outcome Measures:
  • Stem cells circulating in peripheral blood [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Efficacy of SB-509 [ Time Frame: One year ] [ Designated as safety issue: Yes ]

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
1: Experimental
Cohort 1
Drug: SB-509
Active drug
2: Experimental
Cohort 2
Drug: SB-509
Active drug
3: Placebo Comparator
Cohort 3
Drug: Placebo
Placebo
4: Experimental
Cohort 4
Drug: SB-509
Active drug

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Key Inclusion Criteria:

  • Have a clinical diagnosis of diabetes mellitus type I or II for at least 12 months prior to the study.
  • Have received a diagnosis of sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes).
  • Have reduced nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy
  • If female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
  • Have blood pressure < 140/90 mm Hg
  • Body mass index (BMI) < 38 kg/m2

Key Exclusion Criteria:

Subjects with the following are NOT eligible to participate in this study:

  • Have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) within the previous 6 months.
  • Have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity.
  • Have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
  • Have colon polyps. If patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.
  • Require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.
  • Have a known disorder that affects patients' immune systems (such as HIV/AIDS, hepatitis B virus [HBV], hepatitis C virus [HCV], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665145

Locations
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
Sponsors and Collaborators
Sangamo Biosciences
  More Information

Company website  This link exits the ClinicalTrials.gov site

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  
Health Authority: United States: Food and Drug Administration

Keywords provided by Sangamo Biosciences:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Polyneuropathy
Stem Cells

Study placed in the following topic categories:
Metabolic Diseases
Autoimmune Diseases
Diabetic Neuropathies
Polyneuropathies
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus, Type 1
Neuromuscular Diseases
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Diabetes Complications

Additional relevant MeSH terms:
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009