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| Sponsor: | Sangamo Biosciences |
|---|---|
| Information provided by: | Sangamo Biosciences |
| ClinicalTrials.gov Identifier: | NCT00110500 |
Purpose
The purpose of this study is to evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection to subjects with diabetic neuropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Neuropathy |
Genetic: hVEGF-A |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | A Phase I Dose-Escalation Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy |
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Primary objective:
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection. To determine the maximum tolerated dose (MTD) of a single treatment by intramuscular injection by SB-509.
Secondary objective:
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms, neurological examination, and lower extremity electrophysiological testing.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with the following are NOT eligible to participate in this study:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00110500 History of Changes |
| Other Study ID Numbers: | SB-509-0401 |
| Study First Received: | May 9, 2005 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Diabetes Neuropathy |
|
Diabetic Neuropathies Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Poisoning Substance-Related Disorders |