Results of 5-year follow-up study in patients with peripheral artery disease treated with PL-VEGF165 for intermittent claudication

Therapeutic Advances in Cardiovascular Disease
Roman DeevArtur Isaev

Abstract

The effective treatment of chronic lower limb ischemia is one of the most challenging issues confronting vascular surgeons. Current pharmacological therapies play an auxiliary role and cannot prevent disease progression, and new treatment methods are needed. In 2011, a plasmid VEGF65-gene therapy drug was approved in Russia for the treatment of chronic lower limb ischemia ( ClinicalTrials.gov identifier: NCT03068585). The objective of this follow-up study was to evaluate the long-term safety and efficacy of gene therapy in patients with limb ischemia of atherosclerotic genesis. To evaluate the long-term safety and efficacy of the therapeutic angiogenesis, 36 patients in the treatment group (pl- VEGF165) and 12 patients in the control group participated in a 5-year follow-up study. Planned examinations were carried out annually for 5 years after pl- VEGF165 administration. Differences in the frequency of major cardiovascular events (pl- VEGF165 5/36 versus control 2/12; p = 0.85), malignancies (pl- VEGF165 1/36 versus control 0/12; p = 0.38) and impaired vision (there was none in either group) over the 5-year follow-up period did not achieve statistical significance. The target limb salvage was 95% ( n = 36) and 67% ( n = 12) in...Continue Reading

Associated Clinical Trials

References

Apr 5, 2008·Molecular Therapy : the Journal of the American Society of Gene Therapy·Sigrid NikolUNKNOWN TALISMAN 201 investigators
Jun 2, 2009·Journal of Vascular Surgery·Philip P GoodneyRobert M Zwolak
Oct 10, 2009·Circulation Research·Rajesh GuptaDouglas W Losordo
Nov 22, 2013·JAMA Surgery·Philip P GoodneyJohn D Birkmeyer
Mar 15, 2015·Journal of Cardiovascular Pharmacology and Therapeutics·Roman V DeevArtur A Isaev
Apr 25, 2015·Circulation Research·John P Cooke, Douglas W Losordo
Jan 5, 2017·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Roman DeevArtur Isaev
May 1, 2008·Molecular Therapy : the Journal of the American Society of Gene Therapy·Sigrid NikolFrançois Meyer

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Citations

May 10, 2019·Frontiers in Oncology·Reena GoswamiVenkaiah Betapudi
Jan 5, 2021·Frontiers in Cell and Developmental Biology·Roya RamezankhaniEnsiyeh Hajizadeh-Saffar
Dec 31, 2019·Biotechnology Advances·Cui-Cui MaYu-Quan Wei
Feb 23, 2021·Frontiers in Bioengineering and Biotechnology·Ilia Y BozoRoman V Deev
Mar 31, 2021·Drug Discovery Today·Nabil A AlhakamyCory J Berkland
Apr 6, 2021·Synthetic Biology·Mingqi XieMartin Fussenegger
Jun 7, 2021·Cytokine & Growth Factor Reviews·Isabela Gobbo FerreiraEliane Candiani Arantes
Aug 6, 2021·Human Gene Therapy·Grace Elizabeth MuliaMarxa Leão Figueiredo

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Methods Mentioned

BETA
amputation
amputations

Clinical Trials Mentioned

NCT03068585

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