The Experience of Using “Neovasculgen” in the Complex Treatment of Patients with Critical Lower Limb Ischemia

Mikhail M. Vinokurov, Anton A. Yakovlev, Innokenty D. Ushnitsky, Gennady A. Palshin, Aleksander P. Petrov, Vladimir V. Popov, Tatyana V. Yalinskaya

 
International Journal of Biomedicine. 2020;10(3):287-290.
DOI: 10.21103/Article10(3)_ShC1
Originally published September 10, 2020

Abstract: 

This article presents an assessment of the clinical efficacy and long-term results of the use of pl-VEGF165 (a gene therapy drug Neovasculgen) in the treatment of patients with critical lower limb ischemia. The present study revealed a significant decrease in the degree of ischemia, pain reduction and relief; an increase in pain-free walking distance; a regression of trophic disorder; a decrease in the number of amputations; and an increase in the number of lower limb preservations.

Keywords: 
chronic lower limb ischemia • lower extremity arteries • pain-free walking distance • linear blood flow velocity
References: 
  1. Bokeriia LA, Eremeeva MV, Arakelyan VS, Demidova OA. Treatment of chronic lower limb ischemia using neoangiogenesis stimulants. Klinicheskaya Fiziologiia Krovoobrashcheniia. 2013;(1):55-60.
  2. Savel'ev VS, Koshkin VM, Kunizhev AS. Kriticheskaia ishemiia kak sledstvie neadekvatnogo lecheniia bol'nykh khronicheskimi obliteriruiushchimi zabolevaniiami arteriĭ nizhnikh konechnosteĭ na ambulatornom étape [Critical ischemia resulted from inadequate outpatient management of lower limb chronic arterial obliterations]. Angiol Sosud Khir. 2004;10(1):7-10. [Article in Russian]
  3. Cherviakov IuV, Staroverov IN, Nersesian EG, Isaev AA, Deev RV. [Therapeutic Angiogenesis in Treatment of Patients With Chronic Obliterating Diseases of Lower Limb Arteries]. Angiol Sosud Khir. 2012;18(3):19-27. [Article in Russian]
  4. Burger DH, Kappetein AP, Van Bockel JH, Breslau PJ. A prospective randomized trial comparing vein with polytetrafluoroethylene in above-knee femoropopliteal bypass grafting. J Vasc Surg. 2000;32(2):278-283. doi:10.1067/mva.2000.106496
  5. Belch J, Hiatt WR, Baumgartner I, Driver IV,  Nikol S, Norgren L, Belle EV; TAMARIS Committees and Investigators. Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011;377(9781):1929-1937. doi:10.1016/S0140-6736(11)60394-2
  6. Gavrilenko AV, Voronov DA, Konstantinov BA, Bochkov NP. [Combination of Reconstructive Vascular Operations With Gene-Engineering Technologies of Angiogenesis Stimulation: A Present-Day Policy Aimed at Improving the Remote Results of Treating Patients With Lower Limb Chronic Ischaemia]. Angiol Sosud Khir. 2008;14(4):49-53. [Article in Russian].
  7. Human Stem Cells Institute: HSCI receives approval to market Neovasculgen – the first Russian gene-therapy drug for treatment of peripheral arterial disease. Available from: http://eng.hsci.ru/news/press-relizy/hsci-receives-approval-to-market-ne...
  8. Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YuV, et al. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015;20(5):473-482. doi:10.1177/1074248415574336
  9. 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;17(3):235‐242. doi:10.1007/s40256-016-0210-3

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Received May 17, 2020.
Accepted June 20, 2020.
©2020 International Medical Research and Development Corporation.