Journal «Angiology and Vascular Surgery» • 

2014 • VOLUME 20 • №2

Efficacy of using VEGF165 gene in comprehensive treatment of patients with stage 2А-3 lower limb chronic ischaemia

Deev R.V.1, Bozo I.Ya.1, Mzhavanadze N.D.2, Nersesyan E.G.3, Chukhralya O.V.1, Shvalb P.G.2, Chervyakov Yu.V.3, Staroverov I.N.3, Kalinin R.E.2, Voronov D.A.4, Gavrilenko A.V.4, Isaev A.A.1

1) Human Stem Cells Institute, Moscow, Russia,
2) Ryazan State Medical University named after I.P. Pavlov, Ryazan, Russia,
3) Yaroslavl State Medical Academy, Yaroslavl, Russia,
4) B.V. Petrovsky Russian Research Centre of Surgery under the Russian Academy of Medical Sciences

The authors share their experience in treating a total of 100 patients presenting with stage 2A-3 chronic lower limb ischaemia according to the classification of Pokrovsky-Fontain (the clinical group was composed of 75 patients and the control group comprised 25 subjects), in whom it was impossible to perform surgical revascularization. The clinical group patients received in addition to the conventional vascular therapy local intramuscular injections of Neovasculogen (plasmid genetic construction containing human gene VEGF165) at a course dose of 2.4 mg. The results were assessed after 1 year. It was shown that administration of this gene therapeutic agent is safe with no local or systemic allergic reactions and free form neoplastic processes. Efficacy of treatment was assessed by registering the pain-free walking distance (PFWD), transcutaneous oxygen tension (TСPO2), linear velocity of blood flow, ankle-brachial index (ABI), angiography, and by means of SF-36 questionnaire. It was determined that after 12 months the statistical significance of intergroup and intragroup differences was reached for PFWD (increment 167.2%), TСPO2 (increment 20.4%). The highest clinical response for the PFWD was registered in patients with stage 3 of the disease (547.5%), as well as in those with multi-storey vascular lesions (269.1%). The obtained findings make it possible to consider gene therapy with Neovasculogen as an efficient component of comprehensive treatment of this cohort of patients.

KEY WORDS: plasmid DNA, VEGF165 gene, therapeutic angiogenesis, lower limb chronic ischaemia, gene therapy, clinical trial.

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