Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Polyneuropathy
In brief
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)
Key facts
- Study ID
- NCT00665145
- Run by
- Sangamo Therapeutics
- People needed
- 23
- Starts
- 2008-01-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2012-11-01
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
Where it is running
- Study site — La Jolla, California, United States
- Study site — Walnut Creek, California, United States
- Study site — Houston, Texas, United States
- Study site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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