Efficiency, Safety and Portability of Neovasculgen (Neovasculgen)

February 26, 2017 updated by: Human Stem Cell Institute, Russia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Central Russia
      • Moscow, Central Russia, Russian Federation, 119991
        • Russian National Surgery Center by Petrovsky
      • Ryazan, Central Russia, Russian Federation, 390026
        • Ryazansky State Medical University
      • Yaroslavl, Central Russia, Russian Federation, 150000
        • Yaroslavl State Medical Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neovasculgen
DNA encoding the 165-amino-acid isoform of human vascular endothelial growth factor (pCMV - VEGF165)
Drug: Neovasculgen (Cambiogeneplasmid)
treatment
Other Names:
  • Neovasculgen
No Intervention: Control
Control therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Human Stem Cell Institute, Russia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

February 26, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

February 26, 2017

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVG-IC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral Arterial Disease

Clinical Trials on Neovasculgen (Cambiogeneplasmid)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe