Double VEGF/HGF Gene Therapy in Critical Limb Ischemia Complicated by Diabetes Mellitus
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ORIGINAL ARTICLE
Double VEGF/HGF Gene Therapy in Critical Limb Ischemia Complicated by Diabetes Mellitus Piotr Barć 1 & Maciej Antkiewicz 1 & Barbara Śliwa 1 & Katarzyna Frączkowska 1 & Maciej Guziński 2 & Tomasz Dawiskiba 1 & Małgorzata Małodobra-Mazur 3 & Wojciech Witkiewicz 4 & Diana Kupczyńska 1 & Bartłomiej Strzelec 1 & Dariusz Janczak 1 & Jan Paweł Skóra 1 Received: 3 April 2020 / Accepted: 2 August 2020 # The Author(s) 2020
Abstract Critical leg ischemia (CLI) complicated by diabetes mellitus (DM), which is a very common and dangerous disease, represents the ultimate stage of peripheral arterial disease. Patients are treated with antiplatelet drugs, statins and limb revascularization, but a significant number of patients are not candidate for revascularization. Literature shows that in such cases, gene therapy could be a perfect therapeutic option. The aim of our study was to evaluate efficacy of double vascular endothelial growth factor/ hepatocyte growth factor (VEGF/HGF) gene therapy in patients with CLI complicated by DM. We observed that 90 days after administration, serum level of VEGF and ankle-brachial index increased significantly (p < 0.001) and rest pain decreased significantly compared with the control group (p < 0.002). Moreover considerable improvement in vascularization was observed in computed tomography angiography (P = 0.04). Based on the results of this study, we suggest that the therapy with pIRES/ VEGF165/HGF bicistronic plasmid administration is a safe and effective method of treatment of patients with both CLI and DM. Keywords Gene therapy . VEGF . HGF . Critical limb ischemia . Diabetes mellitus
VAS VEGF
Visual analogue scale Vascular endothelial growth factor
Introduction Abbreviations ABI Ankle-brachial index CLI Critical limb ischaemia CTA Computed tomography angiography DM Diabetes mellitus FGF Fibroblast growth factor HGF Hepatocyte growth factor NCR Not candidate for revascularization NYHA New York Heart Association PAD Peripheral arterial disease
Critical leg ischemia (CLI) indicates the final stage of peripheral arterial disease (PAD). Due to the fact that CLI is most commonly caused by atherosclerosis obliterans, it is heavily associated with smoking and diabetes mellitus (DM) [5, 6, 17]. PAD leads to approximately 500–1000 new cases of CLI per million people per year and it touches men three times more often than women [1–3, 5, 6, 17]. Revascularization is a cornerstone of therapy to prevent limb amputation, and despite advance in both open and endovascular surgery, many
Associate Editor Junjie Xiao oversaw the review of this article * Maciej Antkiewicz [email protected] 1
Department and Clinic of Vascular, General and Transplantation Surgery, Jan Mikulicz-Radecki Medical University Hospital, Wroclaw Medical University, Wroclaw, Poland
2
Department of Radiology, Jan Mikulicz-Radecki Medical University Hospital, Wroclaw Medical University, Wroclaw, Poland
3
Molecular Techniques Unit, Wroclaw Medical University, Wroclaw, Poland
4
Regional Specialized Ho
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