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Manipulating angiogenesis against vascular disease

HOSPITAL PRACTICE 1999年第6期34卷 69-+页

作者： Isner, JM Tufts Univ Sch Med Boston MA 02111 USA

Gene therapy to stimulate the growth of new blood vessels is proving to be an effective way of bypassing occluded arteries and reestablishing blood flow to ischemic tissues. It could eventually replace surgical revascularization and angioplasty, which are not only more invasive but also plagued with restenosis, problems limiting long-term. management of coronary artery and peripheral vascular disease.

关键词：内皮生长因子/生理学内皮生长因子/治疗应用淋巴因子/生理学淋巴因子/治疗应用新生血管化生理性/药物作用新生血管化生理性/遗传学增量调节血管疾病/治疗血管内皮生长因子A 血管内皮生长因子类成年人女(雌)性人类男(雄)性

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Evaluation of the effects of intramyocardial injection of DNA expressing vascular endothelial growth factor (VEGF) in a myocardial infarction model in the rat - Angiogenesis and angioma formation

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2000年第5期35卷 1323-1330页

作者： Schwarz, ER Speakman, MT Patterson, M Hale, SS Isner, JM Kedes, LH Kloner, RA Good Samaritan Hosp Inst Heart Los Angeles CA 90017 USA Univ So Calif Div Cardiol Los Angeles CA USA St Elisabeths Med Ctr Div Cardiovasc Res Boston MA USA Tufts Univ Sch Med Boston MA 02111 USA Univ So Calif Dept Med Los Angeles CA USA Univ So Calif Dept Biochem & Mol Biol Los Angeles CA USA

OBJECTIVES The effects of direct intramyocardial injection of the plasmid encoding vascular endothelial growth factor (phVEGF(165)) in the border zone of myocardial infarct tissue in rat hearts were investigated. BACKGROUND Controversy exists concerning the ability of VEGF to induce angiogenesis and enhance coronary flow in the myocardium. METHODS Sprague-Dawley rats received a ligation of the left coronary artery to induce myocardial infarction (MI). At 33.1 +/- 6.5 days, the rats were injected with phVEGF(165) at one location and control plasmid at a second location (500 mu g DNA, n = 24) or saline (n = 16). After 33.1 +/- 5.7 days, the hearts were excised for macroscopic and histologic analysis. Regional blood flow ratios were measured in 18 rats by radioactive microspheres. RESULTS phVEGF(165)-treated sites showed macroscopic angioma- like structures at the injection site while control DNA and saline injection sites did not. By histology, 21/24 phVEGF(165)-treated hearts showed increased focal epicardial blood vessel density and angioma-like formation. Quantitative morphometric evaluation in 20 phVEGF(165)-treated hearts revealed 44.4 +/- 10.5 vascular structures per field in phVEGF(165)-treated hearts versus 21.4 +/- 4.7 in control DNA injection sites (p < 0.05). Regional myocardial blood flow ratios between the injection site and noninfarcted area did not demonstrate any difference between phVEGF(165)-treated hearts (0.9 +/- 0.2) and saline-treated hearts (0.7 +/- 0.1). CONCLUSIONS Injection of DNA for VEGF in the border zone of MI in rat hearts induced angiogenesis. Angioma formation at the injection sites did not appear to contribute to regional myocardial blood how, which may be a limitation of gene therapy for this application. a Am Coil Cardiol 2000;35:1323-30) (C) 2000 by the American College of Cardiology.

关键词：冠状动脉循环/药物作用疾病模型动物药物评价临床前内皮生长因子/副作用内皮生长因子/遗传学内皮生长因子/治疗应用心脏肿瘤/化学诱导心脏肿瘤/病理学血管瘤/化学诱导血管瘤/病理学注射淋巴因子/副作用淋巴因子/遗传学淋巴因子/治疗应用心肌梗死/病理学心肌梗死/治疗新生血管化生理性/药物作用质粒/副作用质粒/遗传学质粒/治疗应用随机分配大鼠 Sprague-Dawley 血管内皮生长因子A 血管内皮生长因子类动物大鼠

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Regional angiogenesis with vascular endothelial growth factor (VEGF) in peripheral arterial disease: Design of the RAVE trial

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AMERICAN HEART JOURNAL 2003年第6期145卷 1114-1118页

作者： Rajagopalan, S Mohler, E Lederman, RJ Saucedo, J Mendelsohn, FO Olin, J Blebea, J Goldman, C Trachtenberg, JD Pressler, M Rasmussen, H Annex, BH Hirsch, AT Univ Michigan Hlth Syst Dept Internal Med Div Cardiol Sect Vasc Med Ann Arbor MI USA Univ Penn Med Ctr Philadelphia Heart Inst Philadelphia PA 19104 USA NHLBI Cardiovasc Branch NIH Bethesda MD 20892 USA Univ Arkansas Dept Cardiol Little Rock AR 72204 USA Baptist Med Ctr Princeton Dept Cardiol Birmingham AL USA Inst Heart & Vasc Morristown NJ USA Penn State Univ Milton S Hershey Med Ctr Dept Vasc Surg Hershey PA 17033 USA Watson Clin LLP Lakeland FL USA Decatur Mem Hosp Decatur IL USA Pfizer Global Res & Dev Ann Arbor MI USA GenVec Gaithersburg MD USA Duke Univ Dept Med Div Cardiol Durham NC USA Durham Vet Affairs Med Ctr Durham NC USA Univ Minnesota Sch Med Div Cardiovasc Minnesota Vasc Dis CtrVasc Med Program Minneapolis MN 55455 USA

Background Patients with intermittent claudication caused by infrainguinal atherosclerosis have limited pharmacologic options "Therapeutic angiogenesis" is a novel treatment approach that seeks to improve perfusion of ischemic limbs by the induction of collateral vessel formation. This trial is a phase 2 randomized double-blind placebo-controlled proof of concept trial that will use an intramuscular adenoviral gene transfer approach of vascular endothelial growth factor, 12 1 isoform (Ad(GV)VEGF(121.10)) to patients with severe IC caused by infrainguinal disease. Methods This is a phase 2, double-blind, randomized, placebo-controlled, dose-finding, multicenter study. Patients with severe intermittent claudication caused by infrainguinal atherosclerosis predominantly involving the superficial femoral artery confirmed with imaging studies that meet inclusion criteria will be stratified on the basis of the presence or absence of diabetes mellitus and randomized in a 1 :1 :1 fashion to low dose (4 x 10(9) particle units);high dose (4 x 10(10) particle units), or placebo arms (35-36 patients per group). Subjects are required to have exercise-limiting IC in the index extremity during 2 qualifying exercise treadmill tests, with peak walking times between 1 and 10 minutes. A single dose of Ad(GV)VEGF(121.10) will be administered as 20 intramuscular injections throughout the area of the lower limb requiring collateralization. Results The primary efficacy parameter for the Regional Angiogenesis With Vascular Endothelial Growth Factor (RAVE) trial is the change in peak walking time at 12 weeks compared with baseline. The sample size is expected to provide an 80% power to detect a difference of 1.5 minutes between any of the 2 treatment groups and the placebo group. Secondary efficacy parameters include claudication onset time, hemodynamic effects of therapy assessed with ankle-brachial index, assessment of physical impairment, and health-related quality of life as measured wit

关键词：腺病毒科双盲法内皮生长因子/遗传学内皮生长因子/治疗应用基因转移技术遗传载体/治疗应用胞间信号肽类和蛋白质类/遗传学胞间信号肽类和蛋白质类/治疗应用间歇性跛行/遗传学间歇性跛行/治疗淋巴因子/遗传学淋巴因子/治疗应用新生血管化生理性/遗传学病人遴选研究设计血管内皮生长因子A 血管内皮生长因子类成年人老年人老年人 80以上人类中年人

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Regulation of VEGF in diabetic patients with critical limb ischemia

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ANNALS OF VASCULAR SURGERY 2001年第3期15卷 388-392页

作者： Hochberg, I Hoffman, A Levy, AP Technion Israel Inst Technol Fac Med IL-31096 Haifa Israel Rambam Med Ctr Dept Vasc Surg Haifa Israel

Diabetic patients are at a 10- to 20-fold increased risk for the development of critical limb ischemia. Vascular endothelial growth factor (VEGF) is critical for the development of collateral blood vessels, which can effectively bypass peripheral arterial occlusions. We therefore set out to determine if the regulation of VEGF in patients with peripheral vascular disease differs in diabetic and nondiabetic patients. Diabetic and nondiabetic patients with peripheral vascular disease were divided into those with or without critical limb ischemia as defined by clinical criteria (rest pain, nonhealing ulcer), Monocytes from peripheral blood were isolated from all patients and the hypoxic induction of VEGF was determined in vitro. In patients without diabetes, we found that there was no significant difference in the hypoxic induction of VEGF between patients with or without critical limb ischemia. However, in diabetic patients we found that patients with critical limb ischemia produced significantly more VEGF than patients without critical limb ischemia (6.3 +/- 1.3 vs. 2.1 +/- 0.3, p < 0.015). We conclude that diabetic patients with critical limb ischemia do not have an impairment in the ability to produce VEGF with hypoxia. Contrary to current dogma, treatment paradigms directed at increasing VEGF production in the diabetic patient with critical limb ischemia might not be beneficial.

关键词：危重病糖尿病血管病变/并发症糖尿病血管病变/药物疗法内皮生长因子/治疗应用缺血/药物疗法缺血/病因学腿/血液供给淋巴因子/治疗应用蛋白质亚型/治疗应用血管内皮生长因子A 血管内皮生长因子类老年人人类中年人

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Intracoronary administration of recombinant human vascular endothelial growth factor to patients with coronary artery disease

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AMERICAN HEART JOURNAL 2001年第5期142卷 872-880页

作者： Henry, TD Rocha-Singh, K Isner, JM Kereiakes, DJ Giordano, FJ Simons, M Losordo, DW Hendel, RC Bonow, RO Eppler, SM Zioncheck, TF Holmgren, EB McCluskey, ER Hennepin Cty Med Ctr Div Cardiol Minneapolis MN 55415 USA Prairie Cardiovasc Springfield IL USA St Elizabeths Med Ctr Boston MA USA Christ Hosp Cincinnati OH 45219 USA Univ Calif San Diego San Diego CA 92103 USA Beth Israel Hosp Boston MA USA NW Med Ctr Chicago IL USA Genentech Inc S San Francisco CA 94080 USA

Background Patients with severe myocardial ischemia who are not candidates for percutaneous or surgical revascularization have few therapeutic options. Therapeutic angiogenesis in animal models with use of recombinant human vascular endothelial growth factor (rhVEGF) has resulted in successful revascularization of ischemic myocardium. This was a dose escalation trial designed to determine the safety and tolerability of intracoronary rhVEGF infusions. Methods and Results Patients were eligible if they had stable exertional angina, a significant reversible perfusion defect by stress myocardial perfusion study, and coronary anatomy that was suboptimal for percutaneous coronary intervention or coronary artery bypass grafting. rhVEGF was administered to a total of 15 patients by 2 sequential (eg, right and left) intracoronary infusions, each for 10 minutes, at rates of 0.005 (n = 4), 0.017 (n = 4), 0.050 (n = 4), and 0.167 mug/kg/min (n = 3). Pharmacokinetic sampling and hemodynamic monitoring were performed for 24 hours. Radionuclide myocardial perfusion imaging was performed before treatment and at 30 and 60 days after treatment. Follow-up angiograms were performed on selected patients at 60 days. The maximally tolerated intracardiac dose of rhVEGF was 0.050 mug/kg/min. Minimal hemodynamic changes were seen at 0.0050 mug/kg/min (2% +/- 7% [SD] mean decrease in systolic blood pressure from baseline to nadir systolic blood pressure), whereas at 0.167 mug/kg/min there was a 28% +/- 7% mean decrease from baseline to nadir (136 to 95 mm Hg systolic). Myocardial perfusion imaging was improved in 7 of 14 patients at 60 days. All 7 patients with follow-up angiograms had improvements in the collateral density score. Conclusion rhVEGF appears well tolerated by coronary infusion at rates up to 0.050 mug/kg/min. This study provides the basis for future clinical trials to assess the clinical benefit of therapeutic angiogenesis with rhVEGF.

关键词：淋巴因子/投药和剂量淋巴因子/药理学淋巴因子/治疗应用新生血管化生理性/药物作用蛋白质亚型/投药和剂量蛋白质亚型/药理学蛋白质亚型/治疗应用重组蛋白质类/投药和剂量重组蛋白质类/药理学重组蛋白质类/治疗应用血管内皮生长因子A 血管内皮生长因子类人类

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Role of single photon emission computed tomography imaging in the evaluation of therapy for angina pectoris

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AMERICAN HEART JOURNAL 2003年第6期145卷 952-961页

作者： Patel, AD Iskandrian, AE Univ Alabama Birmingham Dept Med Div Cardiovasc Dis Birmingham AL 35294 USA

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Therapeutic angiogenesis: Time for the next phase

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2000年第4期36卷 1245-1247页

作者： Pantely, GA Porter, JM Oregon Hlth Sci Univ Dept Med Cardiol Portland OR 97201 USA Oregon Hlth Sci Univ Dept Vasc Surg Portland OR 97201 USA

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Fibrin meshwork as a carrier for delivery of angiogenic growth factors in patients with ischemic limb

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MAYO CLINIC PROCEEDINGS 1999年第8期74卷 847-848页

作者： Kipshidze, N Chawla, P Keelan, MH Med Coll Wisconsin Milwaukee WI 53226 USA

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Epicardial gene therapy and laser revascularization

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Current Cardiology Reports 1999年第4期1卷 335-343页

作者： Symes, James F. St. Elizabeth's Medical Center Boston MA 02135 11 Nevins Street United States

Despite the proven effectiveness of coronary bypass surgery and percutaneous angioplasty techniques, an increasing number of patients are presenting with severe, medically intractable angina who are not candidates for either procedure. Two alternative strategies, transmyocardial laser revascularization and exogeneous administration of angiogenic growth factors (therapeutic angiogenesis) are currently being evaluated in such patients. This review focuses on the current status of these two procedures, emphasizing their similarities and differences in order to provide insight into what role each may ultimately play in the management of patients with otherwise unrevascularizable myocardial ischemia. Copyright © 1999 by Current Science Inc.

关键词：投药皮肤综合疗法冠心病/外科学冠心病/治疗费用效益分析内皮生长因子/治疗应用成纤维细胞生长因子/治疗应用基因疗法淋巴因子/治疗应用心肌血管重建术/方法心包/外科学转染血管内皮生长因子A 血管内皮生长因子类动物人类

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Therapeutic angiogenesis: Theoretic problems using vascular endothelial growth factor

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Current Cardiology Reports 2000年第1期2卷 24-28页

作者： Baumgartner, Iris University Hospital Swiss Cardiovascular Center Division of Angiology 3010 Bern reiburgstraße Switzerland

Aniogenic growth factors constitute a potentially novel form of therapy for patients with ischemic vascular disease. In case of vascular endothelial growth factor (VEGF), a cytokine secreted from intact cells, bioavailability and meaningful angiogenic bioactivity was shown to be achievable by intramuscular gene transfer in patients with chronic critical limb ischemia. Angiogenesis, however, is a two-sided coin with detrimental consequences in non-target tissues. In particular, the theoretic risk of tumor or plaque angiogenesis must not be ignored, though based on experimental and clinical data there is every reason to believe that a short-term increase of circulating VEGF is safe. More sophisticated remains the controversy concerning mechanisms involved in apparent clinical benefits of growth factors (or growth factor genes). This article argues some theoretic problems using naked plasmid DNA encoding VEGF for the purpose of therapeutic angiogenesis. Copyright © 2000 by Current Science Inc.

关键词：血管成形术气囊细胞分裂侧支循环/生理学内皮生长因子/遗传学内皮生长因子/治疗应用内皮血管/细胞学基因疗法缺血/病理生理学缺血/治疗淋巴因子/遗传学淋巴因子/治疗应用新生血管化生理性蛋白质亚型/治疗应用血管内皮生长因子A 血管内皮生长因子类动物人类

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