Arterial gene transfer for therapeutic angiogenesis in patients with peripheral artery disease

Human Gene Therapy

Volumn 7, Issue 8, 1996, Pages 959-988

  Isner, Jeffrey M ^a   Walsh, Ken ^a   Symes, James ^a   Pieczek, Ann ^a   Takeshita, Satoshi ^a   Lowry, Jason ^a   Rosenfield, Kenneth ^a   Weir, Lawrence ^a   Brogi, Edi ^a   Jurayj, Dan ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

COMPLEMENTARY DNA; VASCULOTROPIN;

ADULT; ANGIOGENESIS; ANGIOGRAPHY; ANGIOPLASTY; ARTERY DISEASE; ARTERY OCCLUSION; ARTICLE; BALLOON CATHETER; BOLUS INJECTION; CLINICAL PROTOCOL; CLINICAL TRIAL; FEMALE; GENE TRANSFER; HEART HEMODYNAMICS; HISTOLOGY; HUMAN; INTRAARTERIAL DRUG ADMINISTRATION; LIMB ISCHEMIA; MALE; PATIENT SELECTION; PHYSIOLOGY; PLASMID; PREVALENCE;

EID: 19144371999     PISSN: 10430342     EISSN: None     Source Type: Journal    
DOI: 10.1089/hum.1996.7.8-959     Document Type: Article

References (78)

1. Criqui MH, Fronek A, Barret-Connor EK, Klauber MR, Gabriel S, Goodman D: The prevalence of peripheral arterial disease in a defined population. Circulation 1985;71:510-515
2. European Working Group on Critical Leg Ischemia: Second European consensus document on chronic critical leg ischemia. Circulation 1991;84:IV-1-IV-26
3. Riessen R, Rahimizadeh H, Blessing E, Takeshita S, Barry JJ, Isner JM: Arterial gene transfer using pure DNA applied directly to a hydrogel-coated angioplasty balloon. Hum Gene Ther 1993;4:749-758
4. Takeshita S, Zheng LP, Asahara T, Riessen R, Brogi E, Ferrara N, Symes JF, Isner JM: In vivo evidence of enhanced angiogenesis following direct arterial gene transfer of the plasmid encoding vascular endothelial growth factor. Circulation 1993;88:I-476 (abstract)
5. Takeshita S, Losordo DW, Kearney M, Isner JM: Time course of recombinant protein secretion following liposome-mediated gene transfer in a rabbit arterial organ culture model. Lab Invest (In Press)
6. Losordo DW, Pickering JG, Takeshita S, Leckre G, Gal D, Weir L, Kearney M, Jekanowski J, Isner JM: Use of the rabbit ear artery to serially assess foreign protein secretion after site specific arterial gene transfer in vivo: Evidence that anatomic identification of successful gene transfer may underestimate the potential magnitude of transgene expression. Circulation 1994;89:785-792
7. Takeshita S, Zheng LP, Brogi E, Kearney M, Pu LQ, Bunting S, Ferrara N, Symes JF, Isner JM: Therapeutic angiogenesis: A single intra-arterial bolus of vascular endothelial growth factor augments revascularization in a rabbit ischemic hindlimb model. J Clin Invest 1994;93:662-670
8. Pu LQ, Jackson S, Lachapelle KJ, Arekat Z, Graham AM, Lisbona R, Brassard R, Carpenter S, Symes JF: A persistent hindlimb ischemia model in the rabbit. J Invest Surg 1994;7:49-60
9. Nabel EG, Yang Z, Liptay S, San H, Gordon D, Haudenschild CC, Nabel GJ: Recombinant platelet-derived growth factor B gene expression in porcine arteries induces intimai hyperplasia in vivo. J Clin Invest 1993;91:1822-1829
10. Nabel EG, Shum L, Pompili VJ, Yang ZY, San H, Shu HB, Liptay S, Gold L, Gordon D, Derynck R, Nabel GJ: Direct gene transfer of transforming growth factor b1 into arteries stimulates fibrocellular hyperplasia. Proc Natl Acad Sci USA (In Press)
11. Marcus ML: The coronary collateral circulation. In: The Coronary Circulation in Health and Disease, edited by Marcus, M.L. New York: McGraw-Hill, 1983, p. 231.
12. Standards of Practice Committee of the Society of Cardiovascular and Interventional Radiology: Guidelines for percutaneous transluminal angioplasty. J Vasc Interven Radiol 1990;1:5-13
13. Albers M, Fratezi AC, DeLuccia N: Assessment of quality of life of patients with severe ischemia as a result of infrainguinal arterial occlusive disease. J Vasc Surg 1992;16:54-59
14. Dormandy JA, Thomas PRS: What is the natural history of a critically ischemic patient with and without his leg? In: Limb Salvage and Amputation for Vascular Disease, edited by Greenhalgh, R.M., Jamieson, C.W. and Nicolaides, A.N. Philadelphia: WB Saunders Co., 1988, p. 11-26
15. Isner JM, Rosenfield K: Redefining the treatment of peripheral artery disease: Role of percutaneous revascularization. Circulation 1993;88:1534-1557
16. Pentecost MJ, Criqui MH, Dorros G, Goldstone J, Johnston KW, Martin EC, Ring EJ, Spies JB: Guidelines for peripheral percutaneous transluminal angioplasty of the abdominal aorta and lower extremity vessels: a statement for health professionals from a special writing group of the Councils on Cardiovascular Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and Epidemiology and Prevention, the American Heart Association. Circulation 1994;89:511-531
17. Folkman J: Tumor angiogenesis: therapeutic implications. N Engl J Med 1971;285:1182-1186
18. Shing Y, Folkman J, Sullivan J, Butterfield R, Murray J, Klagsbrun M: Heparin-affinity purification of a tumor-derived capillary endothelial cell growth factor. Science 1984;223:1296-1299
19. Höckel M, Schlenger K, Doctrow S, Kissel T, Vaupel P: Therapeutic angiogenesis. Arch Surg 1993;128:423-429
20. Baffour R, Berman J, Garb JL, Rhee SW, Kaufman J, Friedmann P: Enhanced angiogenesis and growth of collaterals by in vivo administration of recombinant basic fibroblast growth factor in a rabbit model of acute lower limb ischemia: dose-response effect of basic fibroblast growth factor. J Vasc Surg 1992;16:181-191
21. Pu LQ, Sniderman AD, Brassard R, Lachapelle KJ, Graham AM, Lisbona R, Symes JF: Enhanced revascularization of the ischemic limb by means of angiogenic therapy. Circulation 1993;88:208-215
22. Yanagisawa-Miwa A, Uchida Y, Nakamura F, Tomaru T, Kido H, Kamijo T, Sugimoto T, Kaji K, Utsuyama M, Kurashima C, Ito H: Salvage of infarcted myocardium by angiogenic action of basic fibroblast growth factor. Science 1992;257:1401-1403
23. Ferrara N, Henzel WJ: Pituitary follicular cells secrete a novel heparin-binding growth factor specific for vascular endothelial cells. Biochem Biophys Res Commun 1989;161:851-855
24. Keck PJ, Hauser SD, Krivi G, Sanzo K, Warren T, Feder J, Connolly DT: Vascular permeability factor, an endothelial cell mitogen related to PDGF. Science 1989;246:1309-1342
25. Connolly DR, Olander JV, Heuvelman D, Nelson R, Monsell R, Siegel N, Haymore BL, Leimgruber R, Feder J: Human vascular permeability factor: isolation from U937 cells. J Biol Chem 1989;264:20017-20024
26. Leung DW, Cachianes G, Kuang WJ, Goeddel DV, Ferrara N: Vascular endothelial growth factor is a secreted angiogenic mitogen. Science 1989;246:1306-1309
27. deVries C, Escobedo JA, Ueno H, Houck K, Ferrara N, Williams LT: The fms-like tyrosine kinase, a receptor for vascular endothelial growth factor. Science 1992;255:989-991.
28. Millauer B, Wizigmann-Voos S, Schnurch H, Martinez R, Moller NPH, Risau W, Ulrich A: High affinty VEGF binding and development expression suggest Flk-1 as a major regulator of vasculogenesis and angiogenesis. Cell 1993;72:835-846
29. Terman BI, Dougher-Vermozen M, Carrion ME, Dimitrov D, Armellino DC, Gospodarowicz D, Böhlen P: Identification of the KDR tyrosine kinase as a receptor for vascular endothelial growth factor. Biochem Biophys Res Commun 1992;187:1579-1586
30. Klagsbrun M, D'Amore PA: Regulators of angiogenesis. Annu Rev Physiol 1991;53:217-239
31. Gospodarowicz D, Massoglia S, Cheng J, Fujii DK: Effect of fibroblast growth factor and lypoproteins on the proliferation of endothelial cells derived from bovine adrenal cortex, brain cortex, and corpus luteum capillaries. J Cell Physiol 1986;127:121-136
32. Conn G, Soderman D, Schaeffer M-T, Wile M, Hatcher VB, Thomas KA: Purification of glycoprotein vascular endothelial cell mitogen from a rat glioma cell line. Proc Natl Acad Sci USA 1990;87:1323-1327
33. Shen H, Clauss M, Ryan J, Schmidt A-M, Tijburg P, Borden L, Connolly D, Stern D, Kao J: Characterization of vascular permeability factor/vascular endothelial growth factor receptors on mononuclear phagocytes. Blood 1993;81:2767-2773
34. Clauss M, Gerlach M, Gerlach H, Brett J, Wang F, Familletti PC, Dan Y-CE, Olander JV, Connolly DT, Stern D: Vascular permeability factor: a tumor-derived polypeptide that induces endothelial cell and monocyte procoagulant activity, and promotes monocyte migration. J Exp Med 1990;172:1535-1545
35. Levy AP, Tamargo R, Brem H, Nathans D: An endothelial cell growth factor from the mouse neuroblastoma cell line NB41. Growth Factors 1989;2:9-19
36. Connolly DT, Hewelman DM, Nelson R, Olander JV, Eppley BL, Delfino JJ, Siegel RN, Leimgruber RS, Feder J: Tumor vascular permeability factor stimulates endothelial cell growth and angiogenesis. J Clin Invest 1989;84:1470-1478
37. Takeshita S, Pu L-Q, Zheng L, Ferrara N, Stein LA, Sniderman AD, Isner JM, Symes JF: Vascular endothelial growth factor induces dose-dependent revascularization in a rabbit model of persistent limb ischemia. Circulation (In Press)
38. Isner JM, Kaufman J, Rosenfield K, Pieczek A, Schainfeld R, Ramaswamy R, Kosowsky BD: Combined physiologic and anatomic assessment of percutaneous revascularization using a Doppler guidewire and ultrasound catheter. Am J Cardiol 1993;71:70D-86D
39. Bauters C, Asahara T, Zheng LP, Takeshita S, Bunting S, Ferrara N, Symes JF, Isner JM: Physiologic assessment of angiogenesis induced by vascular endothelial growth factor in a rabbit ischemic hindlimb model. Am J Physiol (In Press)
40. Fram DB, Aretz T, Azrin MA, Mitchel JF, Samady H, Gillam LD, Sahatjian R, Waters D, McKay RG: Localized intramural drug delivery during balloon angioplasty using hydrogel-coated balloons and pressure-augmented diffusion. JACC 1994;23:1550-1577
41. Nunes GL, Hanson SR, King III, SB, Sahatjian RA, Scott NA: Local delivery of a synthetic antithrombin with a hydrogel-coated angioplasty balloon catheter inhibits platelet-dependent thrombosis. JACC 1994;23:1578-1583
42. Chapman GD, Lim CS, Gammon RS, Culp SC, Desper JS, Bauman RP, Swain JL, Stack RS: Gene transfer into coronary arteries of intact animals with a percutaneous balloon catheter. Circ Res 1992;71:27-33
43. Wolff JA, Malone RW, Williams P, Chong W, Acsadi G, Jani A, Feigner PL: Direct gene transfer into mouse muscle in vivo. Science 1990;247:1465-1468
44. Wolff JA, Williams P, Acsadi G, Jiao S, Jani A, Chong W: Conditions affecting direct gene transfer into rodent muscle in vivo. Biotechniques 1991;11:474-485
45. Gal D, Weir L, Leclerc G, Pickering JG, Hogan J, Isner JM: Direct myocardial transfection in two animal models: Evaluation of parameters affecting gene expression and percutaneous gene delivery. Lab Invest 1993;68:18-25
46. Lin H, Parmacek MS, Morle G, Bolling S, Leiden JM: Expression of recombinant genes in myocardium in vivo after direct injection of DNA. Circulation 1990;82:2217-2221
47. Kitsis RN, Buttrick PM, McNally EM, Kaplan ML, Leinwand LA: Hormonal modulation of a gene injected into a rat heart in vivo. Proc Natl Acad Sci USA 1991;88:4138-4142
48. Buttrick PM, Kass A, Kitsis RN, Kaplan ML, Leinwand LA: Behavior of genes directly injected into the rat heart in vivo. Circ Res 1992;70:193-198
49. Leclerc G, Gal D, Takeshita S, Nikol S, Weir L, Isner JM: Percutaneous arterial gene transfer in a rabbit model: Efficiency in normal and balloon-dilated atherosclerotic arteries. J Clin Invest 1992;90:936-944
50. Lim CS, Chapman GD, Gammon RS, Muhlestein JB, Bauman RP, Stack RS, Swain JL: Direct in vivo gene transfer into the coronary artery and peripheral vasculaturr of the intact dog. Circulation 1991;83:2007-2011
51. Willard JE, Landau C, Glamann DB, Burns D, Jessen ME, Pirwitz MJ, Gerard RD, Meidell RS: Genetic modification of the vessel wall: comparison of surgical and catheter-based techniques for delivery of recombinant adenovirus. Circulation 4;89:2190-2197 (abstract)
52. Stratford-Perricaudet LD, Makeh I, Perricaudet M, Briand P: Widespread long-term gene transfer to mouse skeletal muscles and heart. J Clin Invest 1992;90:626-630
53. Mulligan R: The basic science of gene therapy. Science 1993;260:926-932
54. Lemarchand P, Jones M, Yamada I, Crystal RG: In vivo gene transfer and expression in normal uninjured blood vessels using replication-deficient recombinant adenovirus vectors. Circ Res 1993;72:1132-1138
55. Nabel EG, Plautz G, Nabel GJ: Transduction of a foreign histocompatibility gene into the arterial wall induces vasculitis. Proc Natl Acad Sci USA 1992;89:5157-5161
56. Nabel EG, Yang ZY, Plautz G, Forough R, Zhan X, Haudenschild CC, Maciag T, Nabel GJ: Recombinant fibroblast growth factor-1 promotes intimal hyperplasia and angiogenesis in arteries in vivo. Nature 1993;362:844-846
57. Bolin T, Aldman A, Gustavsson P-O, Karlqvist P-A, Stenberg B, Elfstrom J: Hur gar det for patienter med viloischemi som ej opereras? Lakartidningen 1988;85:2398-2399
58. Tischer E, Mitchell R, Hartmann T, Silva M, Gospodarowicz D, Fiddes J, Abraham J: The human gene for vascular endothelial growth factor: multiple protein forms are encoded through alternative exon splicing. J Biol Chem 1991;266:11947-11954
59. Caplen JJ, Gae X, Hayes P, Elaswarapu R, Fisher G, Kinrade E, Chakera A, Schorr J, Hughes B, Dorin JR, Porteous DJ, Alton EWFW, Geddes DM, Coutelle C, Williamson R, Huang L, Gilchrist C: Gene therapy for cystic fibrosis in humans by liposome mediated DNA transfer: the production of resources and the regulatory process. Gene Therapy 1994;1:139-147
60. Nabel G: Proposed amendment to Appendix D of the NIH Guidelines Regarding a Human Gene Therapy Protocol Entitled Immunotherapy of Malignancy by In Vivo Gene Transfer into Tumors. Human Gene Ther 1994;5:236-240
61. Schleef M, Heimann P: Cesium chloride or column preparation? An electron microscopical view of plasmid preparations. Biotechniques 1993;14:544
62. Ehlert F, Bierbaum P, Schorr J: Importance of DNA quality for transfection efficiency. Biotechniques 1993;14:546
63. Acsadi G, Jiao S, Jani A, Duke D, Williams P, Chong W, Wolff JA: Direct gene transfer and expression into rat heart in vivo. The New Biologist 1991;3:71-81
64. Prince MR: Gadolinium-enhanced MR aortography. Radiol 1994;91:155-164
65. Rosenfield K, Kelly SM, Fields CD, Pastore JO, Weinstein R, Palefski P, Langevin RE, Kosowsky BD, Razvi S, Isner JM: Non-invasive assessment of peripheral vascular disease by color flow Doppler/two-dimensional ultrasound. Am J Cardiol 1989;64: 247-251
66. Ferrara N, Winer J, Burton T, Rowland A, Siegel M, Phillips HS, Terrell T, Keller GA, Levinson AD: Expression of vascular endothelial growth factor does not promote transformation but confers a growth advantage in vivo to Chinese hamster ovary cells. J Clin Invest 1992;91:160-170
67. Folkman J, Shing Y: Angiogenesis. J Biol Chem 1992;267: 10931-10934
68. Nabel EG, Gordon D, Yang Z-Y, Xu L, San H, Plautz GE, Wu B-Y, Gao X, Huang L, Nabel GJ: Gene transfer in vivo with DNA-liposome complexes: lack of autoimmunity and gonadal localization. Human Gene Ther 1992;3:649-656
69. Riessen R, Rahimizadeh H, Blessing E, Takeshita S, Barry JJ, Isner JM: Arterial gene transfer using pure DNA applied directly to a hydrogel-coated angioplasty balloon. Human Gene Ther 1993;4:749-758
70. Fram DB, Aretz T, Azrin MA, Mitchel JF, Samady H, Gillam LD, Sahatjian R, Waters D, McKay RG: Localized intramural drug delivery during balloon angioplasty using hydrogel-coated balloons and pressure-augmented diffusion. J Am Coll Cordiol 1994;23: 1550-1577
71. Azrin MA, Mitchel JF, Fram DB, Pederson CA, Cartun RW, Barry J, Bow LM, Waters DD, McKay RG: Decreased platelet deposition and smooth muscle cell proliferation after intramural heparin delivery with hydrogel-coated balloons. Circulation 1994;90: 433-441
72. Nunes GL, Hanson SR, King III, SB, Sahatjian RA, Scott NA: Local delivery of a synthetic antithrombin with a hydrogel-coated angioplasty balloon catheter inhibits platelet-depedent thrombosis. J Am Coll Cardiol 1994;23:1578-1583
73. Riessen R, Isner JM: Prospects for site-specific delivery of pharmacologic and molecular therapies. J Am Coll Cardiol 1994;23: 1234-1244
74. Mitchel JF, Azrin MA, Fram DB, Hong MK, Wong SC, Barry JJ, Bow LM, Curley TM, Kiernan FJ, Waters DD, McKay RG: Inhibition of platelet deposition and lysis of intracoronary thrombus during balloon angioplasty using urokinase-coated hydrogel balloons. Circulation 1994;90:1979-1988
75. Takeshita S, Philbrook M, Rossow ST, Kim EA, Roth L: Successful gene transfer using photo-polymerized hydrogel coatings applied onto endoluminal surface of the artery. Circulation abstract (In Press)
76. Schwartz RS, Stollar BD: Origins of anti-DNA autoantibodies. J Clin Invest 1985;75:321-327
77. Burlingame RW, Boey ML, Starkebaum G, Rubin RL: The central role of chromatin in autoimmune responses to histones and DNA in systemic lupus erythematosus. J Clin Invest 91994; 94:184-192
78. Takeshita S, Bauters C, Asahara T, Zheng LP, Rossow ST, Kearney M, Barry JJ, Ferrara N, Symes JF, Isner JM: Physiologic assessment of angiogenesis by arterial gene therapy with vascular endothelial growth factor. Circulation abstract (In Press)