(Circulation. 1999;100:468-474.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
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
From the Department of Cardiothoracic Surgery (T.K.R., L.Y.L., S.R.P., O.W.I.), Division of Pulmonary and Critical Care Medicine (L.Y.L., S.R.P., N.R.H., T.F., R.G.C.), Division of Cardiology (T.A.S., M.P., G.W.B., R.H., M.S., P.D.K., P.M.O., R.T.H., R.B.D., M.R.P.), Weill Medical College of Cornell University–New York Presbyterian Hospital, New York, NY; GenVec, Inc (T.M.G.), Rockville, Md; and Division of Biostatistics (M.L.L.), North Shore University Hospital, Manhasset, NY.
Correspondence to R.G. Crystal, MD, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, NY 10021. E-mail geneticmedicine{at}mail.med.cornell.edu
Background—Therapeutic angiogenesis, a new experimental strategy for the treatment of vascular insufficiency, uses the administration of mediators known to induce vascular development in embryogenesis to induce neovascularization of ischemic adult tissues. This report summarizes a phase I clinical experience with a gene-therapy strategy that used an E1-E3- adenovirus (Ad) gene-transfer vector expressing human vascular endothelial growth factor (VEGF) 121 cDNA (AdGVVEGF121.10) to induce therapeutic angiogenesis in the myocardium of individuals with clinically significant coronary artery disease.
Methods and Results—AdGVVEGF121.10 was administered to 21 individuals by direct myocardial injection into an area of reversible ischemia either as an adjunct to conventional coronary artery bypass grafting (group A, n=15) or as sole therapy via a minithoracotomy (group B, n=6). There was no evidence of systemic or cardiac-related adverse events related to vector administration. In both groups, coronary angiography and stress sestamibi scan assessment of wall motion 30 days after therapy suggested improvement in the area of vector administration. All patients reported improvement in angina class after therapy. In group B, in which gene transfer was the only therapy, treadmill exercise assessment suggested improvement in most individuals.
Conclusions—The data are consistent with the concept that direct myocardial administration of AdGVVEGF121.10 to individuals with clinically significant coronary artery disease appears to be well tolerated, and initiation of phase II evaluation of this therapy is warranted.
Key Words: angiogenesis • gene therapy • genetics • coronary disease • ischemia
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I. Ahmet, Y. Sawa, T. Yamaguchi, and H. Matsuda Gene transfer of hepatocyte growth factor improves angiogenesis and function of chronic ischemic myocardium in canine heart Ann. Thorac. Surg., April 1, 2003; 75(4): 1283 - 1287. [Abstract] [Full Text] [PDF]
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T. D. Henry, B. H. Annex, G. R. McKendall, M. A. Azrin, J. J. Lopez, F. J. Giordano, P.K. Shah, J. T. Willerson, R. L. Benza, D. S. Berman, et al. The VIVA Trial: Vascular Endothelial Growth Factor in Ischemia for Vascular Angiogenesis Circulation, March 18, 2003; 107(10): 1359 - 1365. [Abstract] [Full Text] [PDF]
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N. Tomita, R. Morishita, Y. Taniyama, H. Koike, M. Aoki, H. Shimizu, K. Matsumoto, T. Nakamura, Y. Kaneda, and T. Ogihara Angiogenic Property of Hepatocyte Growth Factor Is Dependent on Upregulation of Essential Transcription Factor for Angiogenesis, ets-1 Circulation, March 18, 2003; 107(10): 1411 - 1417. [Abstract] [Full Text] [PDF]
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F. W. Sellke and M. Ruel Vascular growth factors and angiogenesis in cardiac surgery Ann. Thorac. Surg., February 1, 2003; 75(2): S685 - 690. [Abstract] [Full Text] [PDF]
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Y. J. Woo and T. J. Gardner Myocardial Revascularization with Cardiopulmonary Bypass Card. Surg. Adult, January 1, 2003; 2(2003): 581 - 607. [Full Text]
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M. Ruel, R. A. Kelly, and F. W. Sellke Therapeutic Angiogenesis, Transmyocardial Laser Revascularization, and Cell Therapy Card. Surg. Adult, January 1, 2003; 2(2003): 715 - 750. [Full Text]
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T. Funatsu, Y. Sawa, S. Ohtake, T. Takahashi, G. Matsumiya, N. Matsuura, T. Nakamura, and H. Matsuda Therapeutic angiogenesis in the ischemic canine heart induced by myocardial injection of naked complementary DNA plasmid encoding hepatocyte growth factor J. Thorac. Cardiovasc. Surg., December 1, 2002; 124(6): 1099 - 1105. [Abstract] [Full Text]
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K. A. Horvath, J. Doukas, C.-Y. J. Lu, N. Belkind, R. Greene, G. F. Pierce, and D. A. Fullerton Myocardial functional recovery after fibroblast growth factor 2 gene therapy as assessed by echocardiography and magnetic resonance imaging Ann. Thorac. Surg., August 1, 2002; 74(2): 481 - 487. [Abstract] [Full Text] [PDF]
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T.-S. Li, K. Hamano, K. Suzuki, H. Ito, N. Zempo, and M. Matsuzaki Improved angiogenic potency by implantation of ex vivo hypoxia prestimulated bone marrow cells in rats Am J Physiol Heart Circ Physiol, August 1, 2002; 283(2): H468 - H473. [Abstract] [Full Text] [PDF]
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S. Pislaru, S. P. Janssens, B. J. Gersh, and R. D. Simari Defining Gene Transfer Before Expecting Gene Therapy: Putting the Horse Before the Cart Circulation, July 30, 2002; 106(5): 631 - 636. [Full Text] [PDF]
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M. Ruel, R. J. Laham, J. A. Parker, M. J. Post, J. A. Ware, M. Simons, and F. W. Sellke Long-term effects of surgical angiogenic therapy with fibroblast growth factor 2 protein J. Thorac. Cardiovasc. Surg., July 1, 2002; 124(1): 28 - 34. [Abstract] [Full Text] [PDF]
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 B. S. Zuckerbraun and E. Tzeng Vascular Gene Therapy: A Reality of the 21st Century Arch Surg, July 1, 2002; 137(7): 854 - 861. [Abstract] [Full Text] [PDF]
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Y. Taniyama, R. Morishita, M. Aoki, K. Hiraoka, K. Yamasaki, N. Hashiya, K. Matsumoto, T. Nakamura, Y. Kaneda, and T. Ogihara Angiogenesis and Antifibrotic Action by Hepatocyte Growth Factor in Cardiomyopathy Hypertension, July 1, 2002; 40(1): 47 - 53. [Abstract] [Full Text] [PDF]
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E. Leotta, G. Patejunas, G. Murphy, J. Szokol, L. McGregor, J. Carbray, A. Hamawy, D. Winchester, N. Hackett, R. Crystal, et al. Gene therapy with adenovirus-mediated myocardial transfer of vascular endothelial growth factor 121 improves cardiac performance in a pacing model of congestive heart failure J. Thorac. Cardiovasc. Surg., June 1, 2002; 123(6): 1101 - 1113. [Abstract] [Full Text] [PDF]
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K. B. Lemstrom, R. Krebs, A. I. Nykanen, J. M. Tikkanen, R. K. Sihvola, E. M. Aaltola, P. J. Hayry, J. Wood, K. Alitalo, S. Yla-Herttuala, et al. Vascular Endothelial Growth Factor Enhances Cardiac Allograft Arteriosclerosis Circulation, May 28, 2002; 105(21): 2524 - 2530. [Abstract] [Full Text] [PDF]
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S.-i. Yoshimura, R. Morishita, K. Hayashi, J. Kokuzawa, M. Aoki, K. Matsumoto, T. Nakamura, T. Ogihara, N. Sakai, and Y. Kaneda Gene Transfer of Hepatocyte Growth Factor to Subarachnoid Space in Cerebral Hypoperfusion Model Hypertension, May 1, 2002; 39(5): 1028 - 1034. [Abstract] [Full Text] [PDF]
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K. Hamano, T.-S. Li, T. Kobayashi, K. Hirata, M. Yano, M. Kohno, and M. Matsuzaki Therapeutic angiogenesis induced by local autologous bone marrow cell implantation Ann. Thorac. Surg., April 1, 2002; 73(4): 1210 - 1215. [Abstract] [Full Text] [PDF]
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 T. T. Rissanen, I. Vajanto, M. O. Hiltunen, J. Rutanen, M. I. Kettunen, M. Niemi, P. Leppanen, M. P. Turunen, J. E. Markkanen, K. Arve, et al. Expression of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor-2 (KDR/Flk-1) in Ischemic Skeletal Muscle and Its Regeneration Am. J. Pathol., April 1, 2002; 160(4): 1393 - 1403. [Abstract] [Full Text] [PDF]
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M. C. Kim, A. Kini, and S. K. Sharma Refractory angina pectoris: Mechanism and therapeutic options J. Am. Coll. Cardiol., March 20, 2002; 39(6): 923 - 934. [Abstract] [Full Text] [PDF]
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C. L. Grines, M. W. Watkins, G. Helmer, W. Penny, J. Brinker, J. D. Marmur, A. West, J. J. Rade, P. Marrott, H. K. Hammond, et al. Angiogenic Gene Therapy (AGENT) Trial in Patients With Stable Angina Pectoris Circulation, March 19, 2002; 105(11): 1291 - 1297. [Abstract] [Full Text] [PDF]
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W. R. Smythe Gene therapy for thoracic disease: practice, promise, and pragmatism Ann. Thorac. Surg., March 1, 2002; 73(3): 704 - 706. [Full Text] [PDF]
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R. Yang, A. K. Ogasawara, T. F. Zioncheck, Z. Ren, G.-W. He, G. G. DeGuzman, N. Pelletier, B.-Q. Shen, S. Bunting, and H. Jin Exaggerated Hypotensive Effect of Vascular Endothelial Growth Factor in Spontaneously Hypertensive Rats Hypertension, March 1, 2002; 39(3): 815 - 820. [Abstract] [Full Text] [PDF]
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M. Shimpo, U. Ikeda, Y. Maeda, M. Takahashi, H. Miyashita, H. Mizukami, M. Urabe, A. Kume, T. Takizawa, M. Shibuya, et al. AAV-mediated VEGF gene transfer into skeletal muscle stimulates angiogenesis and improves blood flow in a rat hindlimb ischemia model Cardiovasc Res, March 1, 2002; 53(4): 993 - 1001. [Abstract] [Full Text] [PDF]
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 S. B. Freedman and J. M. Isner Therapeutic Angiogenesis for Coronary Artery Disease Ann Intern Med, January 1, 2002; 136(1): 54 - 71. [Abstract] [Full Text] [PDF]
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H. Huwer, C. Welter, C. Ozbek, M. Seifert, U. Straub, P. Greilach, G. Kalweit, and H. Isringhaus Simultaneous surgical revascularization and angiogenic gene therapy in diffuse coronary artery disease Eur. J. Cardiothorac. Surg., December 1, 2001; 20(6): 1128 - 1134. [Abstract] [Full Text] [PDF]
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Y. Taniyama, R. Morishita, K. Hiraoka, M. Aoki, H. Nakagami, K. Yamasaki, K. Matsumoto, T. Nakamura, Y. Kaneda, and T. Ogihara Therapeutic Angiogenesis Induced by Human Hepatocyte Growth Factor Gene in Rat Diabetic Hind Limb Ischemia Model: Molecular Mechanisms of Delayed Angiogenesis in Diabetes Circulation, November 6, 2001; 104(19): 2344 - 2350. [Abstract] [Full Text] [PDF]
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R. Khurana, J. F. Martin, and I. Zachary Gene Therapy for Cardiovascular Disease: A Case for Cautious Optimism Hypertension, November 1, 2001; 38(5): 1210 - 1216. [Abstract] [Full Text] [PDF]
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C. Seiler, T. Pohl, K. Wustmann, D. Hutter, P.-A. Nicolet, S. Windecker, F. R. Eberli, and B. Meier Promotion of Collateral Growth by Granulocyte-Macrophage Colony-Stimulating Factor in Patients With Coronary Artery Disease: A Randomized, Double-Blind, Placebo-Controlled Study Circulation, October 23, 2001; 104(17): 2012 - 2017. [Abstract] [Full Text] [PDF]
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 M. Azrin Angiogenesis, protein and gene delivery Br. Med. Bull., October 1, 2001; 59(1): 211 - 225. [Abstract] [Full Text] [PDF]
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K. Suzuki, B. Murtuza, R. T. Smolenski, I. A. Sammut, N. Suzuki, Y. Kaneda, and M. H. Yacoub Cell Transplantation for the Treatment of Acute Myocardial Infarction Using Vascular Endothelial Growth Factor-Expressing Skeletal Myoblasts Circulation, September 18, 2001; 104 (2009): I-207 - I-212. [Abstract] [Full Text] [PDF]
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J. M. Isner, P. R. Vale, J. F. Symes, and D. W. Losordo Assessment of Risks Associated With Cardiovascular Gene Therapy in Human Subjects Circ. Res., August 31, 2001; 89(5): 389 - 400. [Abstract] [Full Text] [PDF]
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