Efficiency, Safety and Portability of Neovasculgen

Peripheral Arterial Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068585
• Other study ID #: NVG-IC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 14, 2011
• Last updated: February 26, 2017
• Start date: February 2010
• Est. completion date: July 1, 2011

Study information

• Verified date: June 2011
• Source: Human Stem Cell Institute, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 1, 2011
• Est. primary completion date: June 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Neovasculgen (Cambiogeneplasmid)
treatment

Locations

Country	Name	City	State
Russian Federation	Russian National Surgery Center by Petrovsky	Moscow	Central Russia
Russian Federation	Ryazansky State Medical University	Ryazan	Central Russia
Russian Federation	Yaroslavl State Medical Academy	Yaroslavl	Central Russia

Sponsors (1)

Lead Sponsor	Collaborator
Human Stem Cell Institute, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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 Cardi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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).	6 months
Secondary	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.	6 months
Secondary	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.	6 months