Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia (NVG-LIGHT)

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

International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease

Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open, controlled, prospective, comparative, multicentre study design. All patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. Surgical and endovascular vessel reconstruction was unsuitable for all of the patients

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 4

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
    • Altai Region
      • Barnaul, Altai Region, Russian Federation, 656038
        • "Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution
    • Amur Region
      • Blagoveshchensk, Amur Region, Russian Federation, 675028
        • State Institution of Health Amur Region "Amur Regional Clinical Hospital"
    • Bashkortastan
      • Ufa, Bashkortastan, Russian Federation, 450071
        • City Clinical Hospital # 21 Ufa
    • Buryatiya
      • Ulan-Ude, Buryatiya, Russian Federation, 670031
        • State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "
    • Chelyabinsk Region
      • Chelyabinsk, Chelyabinsk Region, Russian Federation, 454071
        • Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk
    • Irkutsk Region
      • Irkutsk, Irkutsk Region, Russian Federation, 664046
        • Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "
      • Irkutsk, Irkutsk Region, Russian Federation, 664079
        • State Institution of Health Irkutsk "Badge of Honor" Regional Hospital
    • Kemerovo Region
      • Kemerovo, Kemerovo Region, Russian Federation, 650066
        • State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"
    • Kemerovskaya
      • Kemerovo, Kemerovskaya, Russian Federation, 650002
        • Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases
    • Khabarovsk Region
      • Khabarovsk, Khabarovsk Region, Russian Federation, 680009
        • Regional State Budget Institution of Additional Professional Education "Institute of Institute for Advanced Studies of Health Professionals" of the Ministry of Health of the Khabarovsk Region
    • Khanty-Mansiysk District
      • Tyumen, Khanty-Mansiysk District, Russian Federation, 625023
        • State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"
    • Krasnodar Region
      • Krasnodar, Krasnodar Region, Russian Federation, 350086
        • Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region
    • Krasnoyarsk Region
      • Krasnoyarsk, Krasnoyarsk Region, Russian Federation, 660062
        • Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "
    • Mari El Republic
      • Yoshkar-Ola, Mari El Republic, Russian Federation, 424037
        • Republican Clinical Hospital
    • Moscow Region
      • Moscow, Moscow Region, Russian Federation, 129110
        • Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "
    • Novosibirsk Region
      • Novosibirsk, Novosibirsk Region, Russian Federation, 630047
        • State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"
      • Novosibirsk, Novosibirsk Region, Russian Federation, 630117
        • Federal State Institution "Research Institute of Clinical and Experimental Lymphology"
    • Omsk Region
      • Omsk, Omsk Region, Russian Federation, 644111
        • Budget Health Care Institution of Omsk Region "Regional Hospital"
    • Primorsky Region
      • Vladivostok, Primorsky Region, Russian Federation, 690091
        • Public Health Institution "Primorsky Regional Clinical Hospital #1",
    • Rostovskaya
      • Rostov-na-Donu, Rostovskaya, Russian Federation, 344022
        • State Educational Institution of Higher Professional Education "Rostov State Medical University"
    • Saint Petersburg Region
      • Saint Petersburg, Saint Petersburg Region, Russian Federation, 192242
        • St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze
    • Samara Region
      • Samara, Samara Region, Russian Federation, 443095
        • State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "
    • Samara Rigion
      • Togliatti, Samara Rigion, Russian Federation, 445023
        • Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin
    • Sverdlovsk Region
      • Ekaterinburg, Sverdlovsk Region, Russian Federation, 620102
        • Sverdlovsk Regional Clinical Hospital #1
    • Tatarstan
      • Kazan, Tatarstan, Russian Federation, 420064
        • Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
    • Tver Region
      • Tver, Tver Region, Russian Federation, 170020
        • Budgetary State Institution "Regional Hospital"
    • Voronezh Region
      • Voronezh, Voronezh Region, Russian Federation, 394036
        • Voronezh State Medical Academy Named After N.N Burdenko
    • Yamal-Nenets
      • Salekhard, Yamal-Nenets, Russian Federation, 629001
        • State Institution of Health "Salekhard District Hospital"
    • Yaroslavl Region
      • Yaroslavl, Yaroslavl Region, Russian Federation, 150023
        • State Institution of Health Yaroslavl Region "Clinical Hospital # 10"
    • Zabaikalskii Region
      • Chita, Zabaikalskii Region, Russian Federation, 672038
        • State Health Care Institution "Regional Clinical Hospital"

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female person aged 40 or older
  • Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)
  • Signed informed consent

Exclusion Criteria:

  • Any disease that can, in the opinion of the treating physician, affect the outcome of the study
  • Patients with addictive disorders or substance abuse
  • Pregnancy or nursing
  • All other exclusion criteria listed in the summary of product characteristics (SmPC)

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®
Single group prospective treatment
Drug: Neovasculgen®
Treatment according to routine clinical practice at the discretion of the treating physician. Patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC).
Other Names:
  • Neovasculgen
Active Comparator: standard care
Drug: Neovasculgen®
Treatment according to routine clinical practice at the discretion of the treating physician. Patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC).
Other Names:
  • Neovasculgen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the measurement of pain-free walking distance (PWD) on treadmill
Time Frame: 3 months and 6 months after the first injection of Neovasculgen®.
3 months and 6 months after the first injection of Neovasculgen®.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)
Time Frame: From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen®
From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen®
Change in the ankle-brachial index (ABI) after injection of Neovasculgen®
Time Frame: 3 months and 6 months after the first injection of Neovasculgen®
3 months and 6 months after the first injection of Neovasculgen®
Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®
Time Frame: 3 months and 6 months after the first injection of Neovasculgen®
3 months and 6 months after the first injection of Neovasculgen®
Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®
Time Frame: 3 months and 6 months after the first injection of Neovasculgen®
3 months and 6 months after the first injection of Neovasculgen®

Collaborators and Investigators

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

Sponsor

Human Stem Cell Institute, Russia

Investigators

  • Study Director: Roman V Deev, MD, +7 495 646 80 76

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

September 1, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 26, 2017

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVG-03

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.

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