Clinical trial NCT02369809: Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia
Official title: International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Limb Ischemia
Keywords: Ischemia
Lead sponsor: Human Stem Cell Institute, Russia
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 210
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.

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

Eligibility 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)

Primary outcomes:
measure: Change in the measurement of pain-free walking distance (PWD) on treadmill
timeFrame: 3 months and 6 months after the first injection of Neovasculgen®.
Secondary outcomes:
measure: Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)
timeFrame: From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen®
measure: Change in the ankle-brachial index (ABI) after injection of Neovasculgen®
timeFrame: 3 months and 6 months after the first injection of Neovasculgen®
measure: Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®
timeFrame: 3 months and 6 months after the first injection of Neovasculgen®
measure: Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®
timeFrame: 3 months and 6 months after the first injection of Neovasculgen®
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: "Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution
state: Altai Region
city: Blagoveshchensk
country: Russian Federation
facility: State Institution of Health Amur Region "Amur Regional Clinical Hospital"
state: Amur Region
city: Ufa
country: Russian Federation
facility: City Clinical Hospital # 21 Ufa
state: Bashkortastan
city: Ulan-Ude
country: Russian Federation
facility: State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "
state: Buryatiya
city: Chelyabinsk
country: Russian Federation
facility: Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk
state: Chelyabinsk Region
city: Irkutsk
country: Russian Federation
facility: Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "
state: Irkutsk Region
city: Irkutsk
country: Russian Federation
facility: State Institution of Health Irkutsk "Badge of Honor" Regional Hospital
state: Irkutsk Region
city: Kemerovo
country: Russian Federation
facility: State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"
state: Kemerovo Region
city: Kemerovo
country: Russian Federation
facility: Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases
state: Kemerovskaya
city: Khabarovsk
country: Russian Federation
facility: 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
state: Khabarovsk Region
city: Tyumen
country: Russian Federation
facility: State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"
state: Khanty-Mansiysk District
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region
state: Krasnodar Region
city: Krasnoyarsk
country: Russian Federation
facility: Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "
state: Krasnoyarsk Region
city: Yoshkar-Ola
country: Russian Federation
facility: Republican Clinical Hospital
state: Mari El Republic
city: Moscow
country: Russian Federation
facility: Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "
state: Moscow Region
city: Novosibirsk
country: Russian Federation
facility: State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"
state: Novosibirsk Region
city: Novosibirsk
country: Russian Federation
facility: Federal State Institution "Research Institute of Clinical and Experimental Lymphology"
state: Novosibirsk Region
city: Omsk
country: Russian Federation
facility: Budget Health Care Institution of Omsk Region "Regional Hospital"
state: Omsk Region
city: Vladivostok
country: Russian Federation
facility: Public Health Institution "Primorsky Regional Clinical Hospital #1",
state: Primorsky Region
city: Rostov-na-Donu
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "Rostov State Medical University"
state: Rostovskaya
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze
state: Saint Petersburg Region
city: Samara
country: Russian Federation
facility: State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "
state: Samara Region
city: Togliatti
country: Russian Federation
facility: Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin
state: Samara Rigion
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1
state: Sverdlovsk Region
city: Kazan
country: Russian Federation
facility: Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
state: Tatarstan
city: Tver
country: Russian Federation
facility: Budgetary State Institution "Regional Hospital"
state: Tver Region
city: Voronezh
country: Russian Federation
facility: Voronezh State Medical Academy Named After N.N Burdenko
state: Voronezh Region
city: Salekhard
country: Russian Federation
facility: State Institution of Health "Salekhard District Hospital"
state: Yamal-Nenets
city: Yaroslavl
country: Russian Federation
facility: State Institution of Health Yaroslavl Region "Clinical Hospital # 10"
state: Yaroslavl Region
city: Chita
country: Russian Federation
facility: State Health Care Institution "Regional Clinical Hospital"
state: Zabaikalskii Region
Study officials:
affiliation: +7 495 646 80 76
name: Roman V Deev, MD
role: STUDY_DIRECTOR
References:
citation: Deev R, Plaksa I, Bozo I, Isaev A. Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease. Am J Cardiovasc Drugs. 2017 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.