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Trial record 32 of 75 for:    stem cell peripheral arterial disease AND Arterial Disease

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

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ClinicalTrials.gov Identifier: NCT02369809
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Human Stem Cell Institute, Russia

Brief Summary:
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®.

Condition or disease Intervention/treatment Phase
Lower Limb Ischemia Drug: Neovasculgen® Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
Study Start Date : September 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

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 Name: 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 Name: Neovasculgen




Primary Outcome Measures :
  1. 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®. ]

Secondary Outcome Measures :
  1. 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® ]
  2. 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. Change in blood flow linear velocity (BFLV) after injection of Neovasculgen® [ Time Frame: 3 months and 6 months after the first injection of Neovasculgen® ]
  4. Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen® [ Time Frame: 3 months and 6 months after the first injection of Neovasculgen® ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02369809


Locations
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Russian Federation
"Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution
Barnaul, Altai Region, Russian Federation, 656038
State Institution of Health Amur Region "Amur Regional Clinical Hospital"
Blagoveshchensk, Amur Region, Russian Federation, 675028
City Clinical Hospital # 21 Ufa
Ufa, Bashkortastan, Russian Federation, 450071
State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "
Ulan-Ude, Buryatiya, Russian Federation, 670031
Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk
Chelyabinsk, Chelyabinsk Region, Russian Federation, 454071
Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "
Irkutsk, Irkutsk Region, Russian Federation, 664046
State Institution of Health Irkutsk "Badge of Honor" Regional Hospital
Irkutsk, Irkutsk Region, Russian Federation, 664079
State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"
Kemerovo, Kemerovo Region, Russian Federation, 650066
Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases
Kemerovo, Kemerovskaya, Russian Federation, 650002
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
Khabarovsk, Khabarovsk Region, Russian Federation, 680009
State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"
Tyumen, Khanty-Mansiysk District, Russian Federation, 625023
Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region
Krasnodar, Krasnodar Region, Russian Federation, 350086
Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "
Krasnoyarsk, Krasnoyarsk Region, Russian Federation, 660062
Republican Clinical Hospital
Yoshkar-Ola, Mari El Republic, Russian Federation, 424037
Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "
Moscow, Moscow Region, Russian Federation, 129110
State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"
Novosibirsk, Novosibirsk Region, Russian Federation, 630047
Federal State Institution "Research Institute of Clinical and Experimental Lymphology"
Novosibirsk, Novosibirsk Region, Russian Federation, 630117
Budget Health Care Institution of Omsk Region "Regional Hospital"
Omsk, Omsk Region, Russian Federation, 644111
Public Health Institution "Primorsky Regional Clinical Hospital #1",
Vladivostok, Primorsky Region, Russian Federation, 690091
State Educational Institution of Higher Professional Education "Rostov State Medical University"
Rostov-na-Donu, Rostovskaya, Russian Federation, 344022
St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze
Saint Petersburg, Saint Petersburg Region, Russian Federation, 192242
State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "
Samara, Samara Region, Russian Federation, 443095
Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin
Togliatti, Samara Rigion, Russian Federation, 445023
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg, Sverdlovsk Region, Russian Federation, 620102
Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
Kazan, Tatarstan, Russian Federation, 420064
Budgetary State Institution "Regional Hospital"
Tver, Tver Region, Russian Federation, 170020
Voronezh State Medical Academy Named After N.N Burdenko
Voronezh, Voronezh Region, Russian Federation, 394036
State Institution of Health "Salekhard District Hospital"
Salekhard, Yamal-Nenets, Russian Federation, 629001
State Institution of Health Yaroslavl Region "Clinical Hospital # 10"
Yaroslavl, Yaroslavl Region, Russian Federation, 150023
State Health Care Institution "Regional Clinical Hospital"
Chita, Zabaikalskii Region, Russian Federation, 672038
Sponsors and Collaborators
Human Stem Cell Institute, Russia
Investigators
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Study Director: Roman V Deev, MD +7 495 646 80 76

Publications:
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Responsible Party: Human Stem Cell Institute, Russia
ClinicalTrials.gov Identifier: NCT02369809     History of Changes
Other Study ID Numbers: NVG-03
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2015
Keywords provided by Human Stem Cell Institute, Russia:
Ischemia
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes