Information de reference pour ce titreAccession Number: | 00127825-201509000-00004.
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Author: | Deev, Roman V. MD, PhD 1, 2; Bozo, Ilia Y. MD 1, 3, 4; Mzhavanadze, Nina D. MD, PhD 5; Voronov, Dmitriy A. MD, PhD 6; Gavrilenko, Aleksandr V. MD, PhD, ScD 6; Chervyakov, Yuriy V. MD, PhD, ScD 7; Staroverov, Ilia N. MD, PhD 7; Kalinin, Roman E. MD, PhD, ScD 5; Shvalb, Pavel G. MD, PhD, ScD 5, +; Isaev, Artur A. MD 1
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Institution: | (1) OJSC "Human Stem Cells Institute", Moscow, Russia (2) Department of Morphology and General Pathology, Kazan (Volga region) Federal University, Kazan, Russia (3) Department of Maxillofacial Surgery, A.I. Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia (4) Department of Maxillofacial Surgery, A.I. Burnazyan Medical Biophysical Center, Moscow, Russia (5) Department of Angiology and Vascular Surgery, Ryazan State I.P. Pavlov Medical University, Ryazan, Russia (6) Department of Vascular Surgery, Russian National Research Center of Surgery, Moscow, Russia (7) Department of Surgery, Yaroslavl State Medical Academy, Yaroslavl, Russia
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Title: | pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia.[Article]
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Source: | Journal of Cardiovascular Pharmacology & Therapeutics. 20(5):473-482, September 2015.
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Abstract: | Effective treatment of chronic lower limb ischemia is one of the most challenging issues confronting vascular surgeons. There are a number of choices available to the vascular surgeon. Open or endovascular revascularization is the treatment of choice when applicable. Current pharmacological therapies play an auxiliary role and cannot prevent disease progression. Therefore, new methods of treatment are needed. We conducted a phase 2b/3 multicenter randomized controlled clinical trial of the intramuscular transfer of a plasmid DNA encoding vascular endothelial growth factor (VEGF) 165 with cytomegalovirus promotor (CMV) in patients with atherosclerotic lower limb ischemia. A total of 100 patients were enrolled in the study, that is, 75 patients were randomized into the test group and received 2 intramuscular injections of 1.2 mg of pCMV-vegf165, 14 days apart together with standard pharmacological treatment. In all, 25 patients were randomized into the control group and received standard treatment only. The following end points were evaluated within the first 6 months of the study and during a 1.5-year additional follow-up period: pain-free walking distance (PWD), ankle-brachial index (ABI), and blood flow velocity (BFV). The pCMV-vegf165 therapy appeared to be significantly more effective than standard treatment. The PWD increased in the test group by 110.4%, 167.2%, and 190.8% at 6 months, 1 year, and 2 years after treatment, respectively. The pCMV-vegf165 intramuscular transfer caused a statistically significant increase in ABI and BFV. There were no positive results in the control group. Thus, pCMV-vegf165 intramuscular gene transfer is an effective method of treatment of moderate to severe claudication due to chronic lower limb ischemia.
(C)2015Sage Publications
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Author Keywords: | chronic lower limb ischemia; VEGF165; gene therapy; clinical trial.
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Language: | English.
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Document Type: | Clinical Study.
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Journal Subset: | Clinical Medicine. Health Professions. Life & Biomedical Sciences. Pharmacology.
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ISSN: | 1074-2484
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NLM Journal Code: | dk2, 9602617
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DOI Number: | https://dx.doi.org/10.1177/10742...- ouverture dans une nouvelle fenêtre
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