VEGF Gene Transfer for Diabetic Neuropathy

Diabetic Neuropathy Clinical Trial

Official title:

p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056290
• Other study ID #: BB-IND 11572
• Secondary ID: NIH #0104-467
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 10, 2003
• Last updated: November 10, 2010
• Start date: December 2002
• Est. completion date: April 2008

Study information

• Verified date: November 2010
• Source: Losordo, Douglas, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic material that is injected into the muscles of the leg. Once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion criteria:

To be eligible to enroll and remain in the study, patients must meet the following criteria:

• Be at least 21 years old.

• Have type I or type II diabetes mellitus and require oral anti-hyperglycemic agents or insulin.

• Have peripheral neuropathy related to diabetes.

Exclusion criteria

Patients are to be excluded from the trial if any of the following conditions are met:

• Have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.

• Be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

Biological:
• VEGF
3 sets of injections, at 2 week intervals
• VEGF
3 sets of injections, at 2 week intervals

Locations

Country	Name	City	State
United States	Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC	Boston	Massachusetts
United States	Columbia University Neuropathy Research Center, Neurological Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Losordo, Douglas, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		6 months	Yes

External Links

•   Caritas St. Elizabeth's Medical Center of Boston