Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Efficiency, Safety and Portability of Neovasculgen (Neovasculgen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03068585
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Human Stem Cell Institute, Russia

Tracking Information
First Submitted Date  ICMJE June 14, 2011
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date March 3, 2017
Actual Study Start Date  ICMJE February 2010
Actual Primary Completion Date June 1, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2017)
Pain-free walking distance. [ Time Frame: 6 months ]
The PWD was determined using a treadmill test with reduced initial speed (1 km/h), as the majority of elderly patients were unable to perform Gardner test or its equivalents.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2017)
  • Ankle-brachial index [ Time Frame: 6 months ]
    The ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg is an indication of blocked arteries due to peripheral artery disease (PAD).
  • Transcutaneous oximetry [ Time Frame: 6 months ]
    Transcutaneous oximetry, tcpO2 or TCOM, is a local, non-invasive measurement reflecting the amount of O2 that has diffused from the capillaries, through the epidermis.
  • quality of life [ Time Frame: 6 months ]
    SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficiency, Safety and Portability of Neovasculgen
Official Title  ICMJE 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
Brief Summary 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
Detailed Description 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE Drug: Neovasculgen (Cambiogeneplasmid)
Other Name: Neovasculgen
Study Arms  ICMJE
  • Experimental: Neovasculgen
    DNA encoding the 165-amino-acid isoform of human vascular endothelial growth factor (pCMV - VEGF165)
    Intervention: Drug: Neovasculgen (Cambiogeneplasmid)
  • No Intervention: Control
    Control therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2017)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2011
Actual Primary Completion Date June 1, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03068585
Other Study ID Numbers  ICMJE NVG-IC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Human Stem Cell Institute, Russia
Study Sponsor  ICMJE Human Stem Cell Institute, Russia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Human Stem Cell Institute, Russia
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP