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hVEGF-A

Phase 1

Diabetic Neuropathy | Gene therapy | Neurology |Sangamo Therapeutics, Inc.|Last Updated: Jun 8, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

hVEGF-A · 1 trial · 1 indication

Phase 1 1
NCT00110500Clinical Trial of SB-509-0401 in Subjects With Diabetic NeuropathyDiabetic Neuropathy
COMPLETED12 Analytics
PHASE1COMPLETED
Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy
Diabetic NeuropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
hVEGF-AGENETIC -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 mild to moderate sensori-motor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrin...

Countries:United States
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Frequently asked questions about hVEGF-A

What is hVEGF-A used for in diabetic neuropathy?

hVEGF-A is an investigational gene therapy being studied for the treatment of diabetic neuropathy. It is designed to deliver the vascular endothelial growth factor A gene to promote nerve health. The therapy is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing hVEGF-A?

hVEGF-A is being developed by Sangamo Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SGMO. The company is conducting clinical research to evaluate the safety and potential efficacy of this gene therapy for diabetic neuropathy.

What phase is hVEGF-A in?

hVEGF-A is in Phase 1 clinical development. A Phase 1 trial has been completed, involving 12 participants with diabetic neuropathy. The therapy remains investigational and is not yet approved for commercial use.

What clinical trials is hVEGF-A in?

hVEGF-A has been studied in one clinical trial, identified as NCT00110500, titled "Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy." This Phase 1 study was completed in the United States and enrolled 12 adults aged 18 years and older.

Is hVEGF-A the same as SB-509-0401?

Yes, hVEGF-A is the same as SB-509-0401. The clinical trial NCT00110500 refers to the therapy as SB-509-0401, which is the investigational name used in the study for hVEGF-A in diabetic neuropathy.