Intramyocardial injection of vascular endothelial growth factor-A 165 plasmid followed by granulocyte-colony stimulating factor to induce angiogenesis in patients with severe chronic ischaemic heart disease

European Heart Journal

Volumn 27, Issue 15, 2006, Pages 1785-1792

  Ripa, Rasmus Sejersten ^a   Wang, Yongzhong ^a   Jørgensen, Erik ^a   Johnsen, Hans Erik ^b   Hesse, Birger ^a   Kastrup, Jens ^a  

^a Rigshospitalet   (Denmark)

^b AALBORG UNIVERSITY HOSPITAL   (Denmark)

Author keywords

Angiogenesis; Cardiovascular diseases; G CSF; Gene therapy; Stem cell

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; RECOMBINANT VASCULOTROPIN; VASCULOTROPIN 165;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ABSENCE OF SIDE EFFECTS; ACUTE ABDOMEN; ADULT; AGED; ANGIOGENESIS; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEART MUSCLE PERFUSION; HEMATOPOIETIC STEM CELL; HUMAN; ISCHEMIC HEART DISEASE; MALE; MUSCLE DISEASE; NONVIRAL GENE DELIVERY SYSTEM; NONVIRAL GENE THERAPY; PLASMID; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; STEM CELL;

ADOLESCENT; ADULT; AGED; CHRONIC DISEASE; CORONARY CIRCULATION; DRUG THERAPY, COMBINATION; FEMALE; GRANULOCYTE COLONY STIMULATING FACTOR, RECOMBINANT; HEMATOPOIETIC STEM CELL MOBILIZATION; HUMANS; INJECTIONS, INTRALESIONAL; MAGNETIC RESONANCE ANGIOGRAPHY; MALE; MIDDLE AGED; MYOCARDIAL ISCHEMIA; NEOVASCULARIZATION, PHYSIOLOGIC; PROSPECTIVE STUDIES; TOMOGRAPHY, EMISSION-COMPUTED, SINGLE-PHOTON; TREATMENT OUTCOME; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 33748044611     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehl117     Document Type: Article

References (32)

1. Kastrup J. Therapeutic angiogenesis in ischaemic heart disease: gene or recombinant vascular growth factor protein therapy? Curr Gene Ther 2003;3:197-206.
2. Isner JM. Myocardial gene therapy. Nature 2002;415:234-239.
3. Lewis BS, Flugelman MY, Weisz A, Keren-Tal I, Schaper W. Angiogenesis by gene therapy: a new horizon for myocardial revascularization? Cardiovasc Res 1997;35:490-497.
4. Kastrup J, Jørgensen E, Ruck A, Tägil K, Glogar D, Ruzyllo W, Bøtker HE, Dudek D, Drvota V, Hesse B, Thuesen L, Blomberg P, Gyongyosi M, Sylvén C. Direct intramyocardial plasmid vascular endothelial growth factor-A165 gene therapy in patients with stable severe angina pectoris. A randomized double-blind placebo-controlled study: the Euroinject One trial. J Am Coll Cardiol 2005;45:982-988.
5. Hedman M, Hartikainen J, Syvanne M, Stjernvall J, Hedman A, Kivela A, Vanninen E, Mussalo H, Kauppila E, Simula S, Narvanen O, Rantala A, Peuhkurinen K, Nieminen MS, Laakso M, Yla-Herttuala S. Safety and feasibility of catheter-based local intracoronary vascular endothelial growth factor gene transfer in the prevention of postangioplasty and in-stent restenosis and in the treatment of chronic myocardial ischaemia: phase II results of the Kuopio Angiogenesis Trial (KAT). Circulation 2003;107:2677-2683.
6. Eppler SM, Combs DL, Henry TD, Lopez JJ, Ellis SG, Yi JH, Annex BH, McCluskey ER, Zioncheck TF. A target-mediated model to describe the pharmacokinetics and hemodynamic effects of recombinant human vascular endothelial growth factor in humans. Clin Pharmacol Ther 2002;72:20-32.
7. Simons M, Annex BH, Laham RJ, Kleiman N, Henry T, Dauerman H, Udelson JE, Gervino EV, Pike M, Whitehouse MJ, Moon T, Chronos NA. Pharmacological treatment of coronary artery disease with recombinant fibroblast growth factor-2: double-blind, randomized, controlled clinical trial. Circulation 2002;105:788-793.
8. Losordo DW, Vale PR, Hendel RC, Milliken CE, Fortuin FD, Cummings N, Schatz RA, Asahara T, Isner JM, Kuntz RE. Phase 1/2 placebo-controlled, double-blind, dose-escalating trial of myocardial vascular endothelial growth factor 2 gene transfer by catheter delivery in patients with chronic myocardial ischemia. Circulation 2002;105:2012-2018.
9. Sylvén C, Sarkar N, Ruck A, Drvota V, Hassan SY, Lind B, Nygren A, Kallner Q, Blomberg P, van der LJ, Lindblom D, Brodin LA, Islam KB. Myocardial Doppler tissue velocity improves following myocardial gene therapy with VEGF-A165 plasmid in patients with inoperable angina pectoris. Coron Artery Dis 2001;12:239-243.
10. Rosengart TK, Lee LY, Patel SR, Sanborn TA, Parikh M, Bergman GW, Hachamovitch R, Szulc M, Kligfield PD, Okin PM, Hahn RT, Devereux RB, Post MR, Hackett NR, Foster T, Grasso TM, Lesser ML, Isom OW, Crystal RG. Angiogenesis gene therapy: phase I assessment of direct intramyocardial administration of an adenovirus vector expressing VEGF121 cDNA to individuals with clinically significant severe coronary artery disease. Circulation 1999;100:468-474.
11. Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation 2001;103:634-637.
12. Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Mobilized bone marrow cells repair the infarcted heart, improving function and survival. Proc Natl Acad Sci USA 2001;98:10344-10349.
13. Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet 2004;364:141-148.
14. Schächinger V, Assmus B, Britten MB, Honold J, Lehmann R, Teupe C, Abolmaali ND, Vogl TJ, Hofmann WK, Martin H, Dimmeler S, Zeiher AM. Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction: final 1 year results of the TOPCARE-AMI Trial. J Am Coll Cardiol 2004;44:1690-1699.
15. Kuethe F, Richartz BM, Sayer HG, Kasper C, Werner GS, Hoffken K, Figulla HR. Lack of regeneration of myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans with large anterior myocardial infarctions. Int J Cardiol 2004;97:123-127.
16. Stamm C, Westphal B, Kleine HD, Petzsch M, Kittner C, Klinge H, Schumichen C, Nienaber CA, Freund M, Steinhoff G. Autologous bone-marrow stem-cell transplantation for myocardial regeneration. Lancet 2003;361:45-46.
17. Perin EC, Dohmann HF, Borojevic R, Silva SA, Sousa AL, Mesquita CT, Rossi MI, Carvalho AC, Dutra HS, Dohmann HJ, Silva GV, Belem L, Vivacqua R, Rangel FO, Esporcatte R, Geng YJ, Vaughn WK, Assad JA, Mesquita ET, Willerson JT. Transendocardial, autologous bone marrow cell transplantation for severe, chronic ischaemic heart failure. Circulation 2003;107:2294-2302.
18. Fuchs S, Satler LF, Kornowski R, Okubagzi P, Weisz G, Baffour R, Waksman R, Weissman NJ, Cerqueira M, Leon MB, Epstein SE. Catheter-based autologous bone marrow myocardial injection in no-option patients with advanced coronary artery disease: a feasibility study. J Am Coll Cardiol 2003;41:1721-1724.
19. Strauer BE, Brehm M, Zeus T, Kostering M, Hernandez A, Sorg RV, Kogler G, Wernet P. Repair of infarcted myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans. Circulation 2002;106:1913-1918.
20. Wang Y, Tägil K, Ripa RS, Nilsson JC, Carstensen S, Jørgensen E, Sondergaard L, Hesse B, Johnsen HE, Kastrup J. Effect of mobilization of bone marrow stem cells by granulocyte colony stimulating factor on clinical symptoms, left ventricular perfusion and function in patients with severe chronic ischaemic heart disease. Int J Cardiol 2005;100:477-483.
21. Hill JM, Syed MA, Arai AE, Powell TM, Paul JD, Zalos G, Read EJ, Khuu HM, Leitman SF, Horne M, Csako G, Dunbar CE, Waclawiw MA, Cannon RO III. Outcomes and risks of granulocyte colony-stimulating factor in patients with coronary artery disease. J Am Coll Cardiol 2005;46:1643-1648.
22. Ripa RS, Jørgensen E, Wang Y, Thune JJ, Nilsson JC, Søndergaard L, Johnsen HE, Køber L, Grande P, Kastrup J. Stem cell mobilization induced by subcutaneous granulocyte-colony stimulating factor to improve cardiac regeneration after acute ST-elevation myocardial infarction. Result of the double-blind, randomized, placebo-controlled stem cells in myocardial infarction (STEMMI) trial. Circulation 2006;113:1983-1992.
23. Kawamoto A, Murayama T, Kusano K, Ii M, Tkebuchava T, Shintani S, Iwakura A, Johnson I, von Samson P, Hanley A, Gavin M, Curry C, Silver M, Ma H, Kearney M, Losordo DW. Synergistic effect of bone marrow mobilization and vascular endothelial growth factor-2 gene therapy in myocardial ischemia. Circulation 2004;110:1398-1405.
24. Kjær A, Cortsen A, Rahbek B, Hasseldam H, Hesse B. Attenuation and scatter correction in myocardial SPET: improved diagnostic accuracy in patients with suspected coronary artery disease. Eur J Nucl Med Mol Imaging 2002;29:1438-1442.
25. Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart: a statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Circulation 2002;105:539-542.
26. Jørgensen E, Madsen T, Kastrup J. Comparison of the left ventricular electromechanical map before percutaneous coronary stent revascularization and at one-month follow-up in patients with a recent ST elevation infarction. Catheter Cardiovasc Interv 2005;64:153-159.
27. Gyongyosi M, Khorsand A, Zamini S, Sperker W, Strehblow C, Kastrup J, Jørgensen E, Hesse B, Tägil K, Bøtker HE, Ruzyllo W, Teresinska A, Dudek D, Hubalewska A, Ruck A, Nielsen SS, Graf S, Mundigler G, Novak J, Sochor H, Maurer G, Glogar D, Sylvén C. NOGA-guided analysis of regional myocardial perfusion abnormalities treated with intramyocardial injections of plasmid encoding vascular endothelial growth factor A-165 in patients with chronic myocardial ischemia: subanalysis of the EUROINJECT-ONE multicenter double-blind randomized study. Circulation 2005;112:I157-I165.
28. Epstein FH, London JF, Peters DC, Goncalves LM, Agyeman K, Taylor J, Balaban RS, Arai AE. Multislice first-pass cardiac perfusion MRI: validation in a model of myocardial infarction. Magn Reson Med 2002;47:482-491.
29. Wang Y, Johnsen HE, Mortensen S, Bindslev L, Ripa RS, Haack-Sørensen M, Jørgensen E, Fang W, Kastrup J. Changes in circulating mesenchymal stem cells, stem cell homing factor, and vascular growth factors in patients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. Heart 2005;92:768-774.
30. Wang Y, Gabrielsen A, Lawler PR, Paulsson-Berne G, Steinbrüchel DA, Hansson GK, Kastrup J. Myocardial gene expression of angiogenic factors in human chronic ischaemic myocardium: influence of acute ischemia/cardioplegia and reperfusion. Microcirculation 2006;13:187-197.
31. Abbott JD, Huang Y, Liu D, Hickey R, Krause DS, Giordano FJ. Stromal cell-derived factor-1alpha plays a critical role in stem cell recruitment to the heart after myocardial infarction but is not sufficient to induce homing in the absence of injury. Circulation 2004;110:3300-3305.
32. Hiasa K, Ishibashi M, Ohtani K, Inoue S, Zhao Q, Kitamoto S, Sata M, Ichiki T, Takeshita A, Egashira K. Gene transfer of stromal cell-derived factor-1alpha enhances ischaemic vasculogenesis and angiogenesis via vascular endothelial growth factor/endothelial nitric oxide synthase-related pathway: next-generation chemokine therapy for therapeutic neovascularization. Circulation 2004;109:2454-2461.