Five-year results of treating patients with chronic lower limb ischaemia by means of gene engineering

Chervyakov Yu.V.^1,2, Staroverov I.N.^1,2, Vlasenko O.N.¹, Bozo I.Ya.³, Isaev A.A.³, Deev R.V.¹

1) Chair of Surgery of the Institute of Postgraduate Education, Yaroslavl State Medical University of the Public Health Ministry of the Russian Federation,
2) Regional Clinical Hospital, Department of Vascular Surgery, Yaroslavl,
3) Human Stem Cells Institute, Moscow, Russia

The authors share their experience in comprehensive conservative treatment of patients presenting with chronic lower limb ischaemia (CLLI) associated with atherosclerosis of peripheral arteries by means of the first Russian registered gene therapeutic agent "Neovasculgen" (plasmid with the vegf165 gene), analysing the long-term outcomes of treating a total of 45 patients with stage II and III CLLI according to the classification of Pokrovsky–Fontain. The patients were followed up for 5 years. Efficacy of treatment was assessed by registering the dynamics of the pain-free walking distance (PFWD), linear blood velocity (LBV), ankle-brachial index (ABI), as well as the limb salvage rate and survival of patients. All patients showed good tolerance of treatment, with neither side effects nor complications noted. Clinical improvement in stage IIB CLLI was observed in 91% of patients with complete stabilization of the clinical course during 5 years. The limb salvage rate in this group amounted to 95%, with the survival rate equalling 82%. In patients with stage III CLLI, improvement was noted in 78% of cases, manifesting itself by a decrease of its degree to stage IIB (44.4%) and to stage IIA (33.3%). Progression of CLLI followed by amputation was registered in 22% of cases, with the survival rate of 78%.

Hence, the use of a single course of combined treatment including the gene therapeutic agent "Neovasculgen" in patients with stage II and III CLLI resulted in a persistent positive effect in a considerable majority of patients in the remote period of not less than 5 years.

KEY WORDS: gene therapy, Neovasculgen, peripheral atherosclerosis, chronic lower limb ischaemia, remote results, vegf165.

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