Efficacy and safety of application «Neovasculgen» in the complex treatment patients with chronic lower limbischemia (IIb-III phase of clinical trials)

P G Shvalb; A V Gavrilenko; R E Kalinin; Yu V Chervyakov; D A Voronov; I N Staroverov; S V Gryaznov; N D Mzavanadze; E G Nersesyan; S L Kiselev; A A Isaev; R V Deev

doi:10.23868/gc121558

Genes & Cells ›› 2011, Vol. 6 ›› Issue (3) : 76 -83. DOI: 10.23868/gc121558

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Efficacy and safety of application «Neovasculgen» in the complex treatment patients with chronic lower limbischemia (IIb-III phase of clinical trials)

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I.P. Pavlov Ryazan State Medical University, Ryazan

B.V. Petrovsky Russian Scientific Center of Surgery, Moscow

Yaroslavl State Medical Academy, Yaroslavl

Human Stem Cells Institute, Moscow

I.P. Pavlov Ryazan State Medical University, Ryazan

B.V. Petrovsky Russian Scientific Center of Surgery, Moscow

I.P. Pavlov Ryazan State Medical University, Ryazan

Yaroslavl State Medical Academy, Yaroslavl

B.V. Petrovsky Russian Scientific Center of Surgery, Moscow

Yaroslavl State Medical Academy, Yaroslavl

I.P. Pavlov Ryazan State Medical University, Ryazan

Yaroslavl State Medical Academy, Yaroslavl

Human Stem Cells Institute, Moscow

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Abstract

The article deals with the results of a 6 monthcomparative follow-up of non-resectable patients withlower limb atherosclerosis having clinical symptoms asclaudication (IIa-III stages according to the Fontaine-Pokrovsky classification) who received Neovasculgenas a part of conservative therapy. Neovasculgen, a genetherapy drug, is a plasmid construction with a vascularendothelial growth factor gene. 100 patients were enrolledinto the study: 75 patients comprised the clinical group,while 25 ones being the controls. The patients underwenttreatment in three clinical centers. The drug was injectedintramuscular, maximally close to ischemia zones, twice indoses of 1.2 mg with the interval of 14 days. The followingfactors were controlled: pain free walking distance (PlWD),ankle-brachial index (ABI), transcutaneous partial pressureof oxygen (TcPO2), linear blood flow rate (LBFR) in theinvolved segment, angiography; also the integral treatmentresult on the scale «success/failure», quality of life SF-36questionnaire were assessed. The study duration was 6months. PlWD was determined to increase by 110% thatshows statistically significant difference versus the control(P=0.000).

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P G Shvalb, A V Gavrilenko, R E Kalinin, Yu V Chervyakov, D A Voronov, I N Staroverov, S V Gryaznov, N D Mzavanadze, E G Nersesyan, S L Kiselev, A A Isaev, R V Deev. Efficacy and safety of application «Neovasculgen» in the complex treatment patients with chronic lower limbischemia (IIb-III phase of clinical trials). Genes & Cells, 2011, 6(3): 76-83 DOI:10.23868/gc121558

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