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Efficiency, Safety and Portability of Neovasculgen (Neovasculgen)

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ClinicalTrials.gov Identifier: NCT03068585
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Human Stem Cell Institute, Russia

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Neovasculgen (Cambiogeneplasmid) Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 2010
Actual Primary Completion Date : June 1, 2011
Actual Study Completion Date : July 1, 2011

Resource links provided by the National Library of Medicine


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 Name: Neovasculgen

No Intervention: Control
Control therapy



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068585


Locations
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Russian Federation
Russian National Surgery Center by Petrovsky
Moscow, Central Russia, Russian Federation, 119991
Ryazansky State Medical University
Ryazan, Central Russia, Russian Federation, 390026
Yaroslavl State Medical Academy
Yaroslavl, Central Russia, Russian Federation, 150000
Sponsors and Collaborators
Human Stem Cell Institute, Russia

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Human Stem Cell Institute, Russia
ClinicalTrials.gov Identifier: NCT03068585     History of Changes
Other Study ID Numbers: NVG-IC
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: June 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Human Stem Cell Institute, Russia:
PAD
CLI
stage 2a-3 of Pokrovsky-Fonteine
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs