Trial | NCT03068585  Report issue

Title

Efficiency, Safety and Portability of Neovasculgen
Phase 3 Study of Efficiency, Safety and Portability of Gene Therapy Drug Neovasculgen (DNA Encoding the 165-amino-acid Isoform of Human Vascular Endothelial Growth Factor (pCMV - VEGF165) for Peripheral Arterial Disease Complex Treatment

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V. Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165 gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The study was conducted under the control of the Russian Ministry of Health and was completed in 2011. Patients enrolled in the study were subjected to a 6-month
We conducted a phase 2b/3 multicenter randomized controlled clinical trial of the intramuscular transfer of a plasmid DNA encoding vascular endothelial growth factor (VEGF) 165 with cytomegalovirus promotor (CMV) in patients with atherosclerotic lower limb ischemia. A total of 100 patients were enrolled in the study, that is, 75 patients were randomized into the test group and received 2 intramuscular injections of 1.2 mg of pCMV- vegf165, 14 days apart together with standard pharmacological treatment. In all, 25 patients were randomized into the control group and received standard treatment only. The following end points were evaluated within the first 6 months of the study and during a 1.5-year additional follow-up period: pain-free walking distance (PWD), ankle-brachial index (ABI), and blood flow velocity (BFV).
Study Started
Feb 28
2010
Primary Completion
Jun 01
2011
Study Completion
Jul 01
2011
Last Update
Mar 03
2017

Drug Neovasculgen (Cambiogeneplasmid)

treatment

  • Other names: Neovasculgen

Neovasculgen Experimental

DNA encoding the 165-amino-acid isoform of human vascular endothelial growth factor (pCMV - VEGF165)

Control No Intervention

Control therapy

Criteria 

Inclusion Criteria:

age more than 40 years;
a history of stable claudication for at least 3 months;
stage 2 to 3 chronic ischemia according to Fontaine classification (modified by A. V. Pokrovsky);
presence of hemodynamically significant (stenosis >70% and/or occlusion) diffuse lesions of the interior and (or) posterior tibial arteries (distal lesion);
voluntary informed consent signed and dated by the patient.

Exclusion Criteria:

chronic lower limb ischemia of nonatherosclerotic genesis; stage 4 chronic ischemia according to Fontaine classification modified by A. V. Pokrovsky (ischemic ulcers and necrotic lesions);
severe concomitant pathology with life expectancy <1 year;
infectious diseases, history of cancer, or suspected malignancy;
No Results Posted