Status:
COMPLETED
Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509
Lead Sponsor:
Sangamo Therapeutics
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 e...
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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).
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00665145
Start Date
January 1 2008
End Date
October 1 2009
Last Update
November 1 2012
Active Locations (4)
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1
La Jolla, California, United States, 92037
2
Walnut Creek, California, United States, 94598
3
Houston, Texas, United States, 77030
4
San Antonio, Texas, United States, 78229