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Efficiency, Safety and Portability of Neovasculgen (Neovasculgen)

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Neovasculgen (Cambiogeneplasmid)
Sponsored by
Human Stem Cell Institute, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring PAD, CLI, stage 2a-3 of Pokrovsky-Fonteine

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Russian National Surgery Center by Petrovsky
  • Ryazansky State Medical University
  • Yaroslavl State Medical Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neovasculgen

Control

Arm Description

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

Control therapy

Outcomes

Primary Outcome Measures

Pain-free walking distance.
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

Ankle-brachial index
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
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
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.

Full Information

First Posted
June 14, 2011
Last Updated
February 26, 2017
Sponsor
Human Stem Cell Institute, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT03068585
Brief Title
Efficiency, Safety and Portability of Neovasculgen
Acronym
Neovasculgen
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
June 1, 2011 (Actual)
Study Completion Date
July 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Stem Cell Institute, Russia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
PAD, CLI, stage 2a-3 of Pokrovsky-Fonteine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neovasculgen
Arm Type
Experimental
Arm Description
DNA encoding the 165-amino-acid isoform of human vascular endothelial growth factor (pCMV - VEGF165)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control therapy
Intervention Type
Drug
Intervention Name(s)
Neovasculgen (Cambiogeneplasmid)
Other Intervention Name(s)
Neovasculgen
Intervention Description
treatment
Primary Outcome Measure Information:
Title
Pain-free walking distance.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ankle-brachial index
Description
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).
Time Frame
6 months
Title
Transcutaneous oximetry
Description
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.
Time Frame
6 months
Title
quality of life
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Facility Information:
Facility Name
Russian National Surgery Center by Petrovsky
City
Moscow
State/Province
Central Russia
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Ryazansky State Medical University
City
Ryazan
State/Province
Central Russia
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Yaroslavl State Medical Academy
City
Yaroslavl
State/Province
Central Russia
ZIP/Postal Code
150000
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25770117
Citation
Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YV, Staroverov IN, Kalinin RE, Shvalb PG, Isaev AA. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):473-82. doi: 10.1177/1074248415574336. Epub 2015 Mar 13.
Results Reference
result
PubMed Identifier
29996720
Citation
Deev R, Plaksa I, Bozo I, Mzhavanadze N, Suchkov I, Chervyakov Y, Staroverov I, Kalinin R, Isaev A. Results of 5-year follow-up study in patients with peripheral artery disease treated with PL-VEGF165 for intermittent claudication. Ther Adv Cardiovasc Dis. 2018 Sep;12(9):237-246. doi: 10.1177/1753944718786926. Epub 2018 Jul 11.
Results Reference
derived

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Efficiency, Safety and Portability of Neovasculgen

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