Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509

This study has been completed.
Sponsor:
Information provided by:
Sangamo Biosciences
ClinicalTrials.gov Identifier:
NCT00665145
First received: April 21, 2008
Last updated: October 30, 2012
Last verified: October 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Stem-Cell-Mobilization in Subjects With Diabetic Neuropathy Receiving SB-509

Resource links provided by NLM:


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 ]

Enrollment: 23
Study Start Date: January 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cohort 1
Drug: SB-509
Active drug
Experimental: 2
Cohort 2
Drug: SB-509
Active drug
Placebo Comparator: 3
Cohort 3
Drug: Placebo
Placebo
Experimental: 4
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665145

Locations
United States, California
La Jolla,, California, United States, 92037
Walnut Creek, California, United States, 94598
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Sangamo Biosciences
  More Information

Additional Information:
No publications provided

Responsible Party: Ely Benaim, M.D., Vice President, Clinical Affairs, Sangamo BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT00665145     History of Changes
Other Study ID Numbers: SB-509-0703
Study First Received: April 21, 2008
Last Updated: October 30, 2012
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetic Neuropathies
Polyneuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 22, 2014