Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509
NCT ID: NCT00665145
Last Updated: 2012-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2008-01-31
2009-10-31
Brief Summary
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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
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This study is intended to further evaluate the mechanism of SB-509 action.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Cohort 1
SB-509
Active drug
2
Cohort 2
SB-509
Active drug
3
Cohort 3
Placebo
Placebo
4
Cohort 4
SB-509
Active drug
Interventions
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SB-509
Active drug
SB-509
Active drug
Placebo
Placebo
SB-509
Active drug
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
18 Years
70 Years
ALL
No
Sponsors
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Sangamo Therapeutics
INDUSTRY
Responsible Party
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Sangamo BioSciences, Inc.
Locations
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La Jolla, California, United States
Walnut Creek, California, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
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Related Links
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Company website
Other Identifiers
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SB-509-0703
Identifier Type: -
Identifier Source: org_study_id