Working… Menu

Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00665145
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : November 1, 2012
Information provided by:
Sangamo Therapeutics

Brief 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)

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Polyneuropathy Drug: SB-509 Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Stem-Cell-Mobilization in Subjects With Diabetic Neuropathy Receiving SB-509
Study Start Date : January 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Experimental: 4
Cohort 4
Drug: SB-509
Active drug

Primary Outcome Measures :
  1. Stem cells circulating in peripheral blood [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Safety and Efficacy of SB-509 [ Time Frame: One year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00665145

Layout table for location information
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 Therapeutics
Additional Information:
Layout table for additonal information
Responsible Party: Ely Benaim, M.D., Vice President, Clinical Affairs, Sangamo BioSciences, Inc. Identifier: NCT00665145    
Other Study ID Numbers: SB-509-0703
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012
Keywords provided by Sangamo Therapeutics:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Polyneuropathy
Stem Cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Neuropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications