Arteriogenesis: Lessons learned from clinical trials

Endothelium: Journal of Endothelial Cell Research

Volumn 10, Issue 4-5, 2003, Pages 217-223

  Baklanov, Dmitri ^a   Simons, Michael ^a  

^a DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

Author keywords

Angiogenesis; Clinical trials; Coronary artery disease; Growth factors

Indexed keywords

ADENOVIRUS VECTOR; FIBROBLAST GROWTH FACTOR 2; FIBROBLAST GROWTH FACTOR 4; FIBROBLAST GROWTH FACTOR RECEPTOR; GROWTH FACTOR; HEPARIN ALGINATE FIBROBLAST GROWTH FACTOR 2; HYPOXIA INDUCIBLE FACTOR 1ALPHA; LIVER ENZYME; NITRATE; PEPTIDE DERIVATIVE; PEPTIDE PR39; PLACEBO; PLATELET DERIVED GROWTH FACTOR BB; UNCLASSIFIED DRUG; VASCULOTROPIN; VASCULOTROPIN C;

ADENOVIRUS 5; ANGIOGENESIS; ARTERY DISEASE; ATHEROSCLEROSIS; BLOOD VESSEL; CLINICAL TRIAL; CORONARY ARTERY BYPASS GRAFT; CORONARY ARTERY DISEASE; DISEASE MODEL; DOSE RESPONSE; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; FOLLOW UP; GENE THERAPY; GENE TRANSFER; HUMAN; HYPOTENSION; LIVER DYSFUNCTION; LOW DRUG DOSE; NONHUMAN; PERIPHERAL VASCULAR DISEASE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; STABLE ANGINA PECTORIS; TREATMENT PLANNING;

ADENOVIRIDAE; HUMAN ADENOVIRUS TYPE 5;

EID: 0345737223     PISSN: 10623329     EISSN: None     Source Type: Journal    
DOI: 10.1080/10623320390246397     Document Type: Review

References (33)

1. Bao J., Sato K., Li M., Gao Y., Abid R., Aird W., Simons M., and Post M.J. (2001) PR-39 and PR-11 peptides inhibit ischemia-reperfusion injury by blocking proteasome-mediated IkappaBalpha degradation. American Journal of Physiology Heart Circulatory Physiology, 281, H2612-H2618.
2. Bush M.A., Samara E., Whitehouse M.J., Yoshizawa C., Novicki D.L., Pike M., Laham R.J., Simons M., and Chronos N.A. (2001) Pharmacokinetics and pharmacodynamics of recombinant FGF-2 in a phase I trial in coronary artery disease. Journal of Clinical Pharmacology, 41, 378-385.
3. Cao R., Brakenhielm E., Pawliuk R., Wariaro D., Post M.J., Wahlberg E., Leboulch P., and Cao Y. (2003) Angiogenic synergism, vascular stability and improvement of hind-limb ischemia by a combination of PDGF-BB and FGF-2. Nature Medicine, 9, 604-613.
4. Dor Y., Djonov V., Abramovitch R., Itin A., Fishman G.I., Carmeliet P., Gelman G., and Keshet E. (2002) Conditional switching of VEGF provides new in-sights into adult neovascularization and pro-angiogenic therapy. EMBO Journal, 21, 1939-1947.
5. Gibson C.M., Ryan K., Sparano A., Moynihan J.L., Rizzo M., Kelley M., Marble S.J., Laham R., Simons M., McClusky T.R., and Dodge Jr. J.T. (1999) Angiographic methods to assess human coronary angiogenesis. American Heart Journal, 137, 169-179.
6. Grines C.L., Watkins M.W., Helmer G., Penny W., Brinker J., Marmur J.D., West A., Rade J.J., Marrott P., Hammond H.K., and Engler R.L. (2002) Angiogenic Gene Therapy (AGENT) trial in patients with stable angina pectoris. Circulation, 105, 1291-1297.
7. Harada K., Friedman M., Lopez J.J., Wang S.Y., Li J., Prasad P.V., Pearlman J.D., Edelman E.R., Sellke F.W., and Simons M. (1996) Vascular endothelial growth factor administration in chronic myocardial ischemia. American Journal of Physiology, 270, H1791-H1802.
8. Harada K., Grossman W., Friedman M., Edelman E.R., Prasad P.V., Keighley C.S., Manning W.J., Sellke F.W., and Simons M. (1994) Basic fibroblast growth factor improves myocardial function in chronically ischemic porcine hearts. Journal of Clinical Investigation, 94, 623-630.
9. 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 M.S., Laakso M., and Yla-Herttuala S. (2003) Safety and feasibility of catheter-based local intracoronary vascular endothelial growth factor gene transfer in the prevention of postangioplasty and instent restenosis and in the treatment of chronic myocardial ischemia: Phase II results of the Kuopio Angiogenesis Trial (KAT). Circulation, 107, 2677-2683.
10. Hendel R.C., Henry T.D., Rocha-Singh K., Isner J.M., Kereiakes D.J., Giordano F.J., Simons M., and Bonow R.O. (2000) Effect of intracoronary recombinant human vascular endothelial growth factor on myocardial perfusion: Evidence for a dose-dependent effect. Circulation, 101, 118-121.
11. Henry T.D., Annex B.H., McKendall G.R., Azrin M.A., Lopez J.J., Giordano F.J., Shah P.K., Willerson J.T., Benza R.L., Berman D.S., Gibson C.M., Bajamonde A., Rundle A.C., Fine J., and McCluskey E.R. (2003) The VIVA trial: Vascular endothelial growth factor in ischemia for vascular angiogenesis. Circulation, 107, 1359-1365.
12. Henry T.D., Rocha-Singh K., Isner J.M., Kereiakes D.J., Giordano F.J., Simons M., Losordo D.W., Hendel R.C., Bonow R.O., Eppler S.M., Zioncheck T.-F., Holmgren E.B., and McCluskey E.R. (2001) Intracoronary administration of recombinant human vascular endothelial growth factor to patients with coronary artery disease. American Heart Journal, 142, 872-880.
13. Laham R.J., Chronos N.A., Pike M., Leimbach M.E., Udelson J.E., Pearlman J.D., Pettigrew R.I., Whitehouse M.J., Yoshizawa C., and Simons M. (2000) Intracoronary basic fibroblast growth factor (FGF-2) in patients with severe ischemic heart disease: Results of a phase I open-label dose escalation study. Journal of American College of Cardiology, 36, 2132-2139.
14. Laham R.J., Rezaee M., Post M., Sellke F.W., Braeckman R.A., Hung D., and Simons M. (1999) Intracoronary and intravenous administration of basic fibroblast growth factor: Myocardial and tissue distribution. Drug Metabolism and Deposition, 27, 821-826.
15. Laham R.J., Sellke F.W., Edelman E.R., Pearlman J.D., Ware J.A., Brown D.L., Gold J.P., and Simons M. (1999) Local perivascular delivery of basic fibroblast growth factor in patients undergoing coronary bypass surgery: Results of a phase I randomized, double-blind, placebo-controlled trial. Circulation, 100, 1865-1871.
16. Lederman R.J., Mendelsohn F.O., Anderson R.D., Saucedo J.F., Tenaglia A.N., Hermiller J.B., Hillegass W.B., Rocha-Singh K., Moon T.E., Whitehouse M.J., and Annex B.H. (2002) Therapeutic angiogenesis with recombinant fibroblast growth factor-2 for intermittent claudication (the TRAFFIC study): A randomised trial. Lancet, 359, 2053-2058.
17. Li J., Post M., Volk R., Gao Y., Li M., Metais C., Sato K., Tsai J., Aird W., Rosenberg R.D., Hampton T.G., Sellke F., Carmeliet P., and Simons M. (2000) PR39, a peptide regulator of angiogenesis. Nature Medicine, 6, 49-55.
18. Lopez J., Laham R.J., Carrozza J.C., Tofukuji M., Sellke F.W., Bunting S., and Simons M. (1997) Hemodynamic effects of intracoronary VEGF delivery: Evidence of tachyphylaxis and NO dependence of response. American Journal of Physiology, 273, H1317-H1323.
19. Lopez J.J., Edelman E.R., Stamler A., Hibberd M.G., Prasad P., Caputo R.P., Carrozza J.C., Douglas P.S., Sellke F.W, and Simons M. (1997) Basic fibroblast growth factor in a porcine model of chronic myocardial ischemia: A comparison of angiographic, echocardiographic and coronary flow parameters. Journal of Pharmacology and Experimental Therapeutics, 282, 385-390.
20. Lopez J.J., Laham R.J., Stamler A., Pearlman J.D., Bunting S., Kaplan A., Carrozza J.P., Sellke F.W., and Simons M. (1998) VEGF administration in chronic myocardial ischemia in pigs. Cardiovascular Research, 40, 272-281.
21. Losordo D.W., Vale P.R., Hendel R.C., Milliken C.E., Fortuin F.D., Cummings N., Schatz R.A., Asahara T., Isner J.M., and Kuntz R.E. (2002) 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, 105, 2012-2018.
22. Morishita R., Aoki M., Yo Y., and Ogihara T. (2002) Hepatocyte growth factor as cardiovascular hormone: Role of HGF in the pathogenesis of cardiovascular disease. Endocrine Journal, 49, 273-284.
23. Pipp F., Heil M., Issbrucker K., Ziegelhoeffer T., Martin S., Van Den Heuvel J., Weich H., Fernandez B., Golombo G., Carmeliet P., Schaper W., and Clauss M. (2003) VEGFR-1-selective VEGF homologue PlGF is arteriogenic: Evidence for a monocyte-mediated mechanism. Circulation Research, 92, 378-385.
24. Ruel M., Laham R.J., Parker J.A., Post M.J., Ware J.A., Simons M., and Sellke F.W. (2002) Long-term effects of surgical angiogenic therapy with fibroblast growth factor 2 protein. Journal of Thoracic and Cardiovascular Surgery, 124, 28-34.
25. Sato K., Laham R.J., Pearlman J.D., Novicki D., Sellke F.W., Simons M., and Post M.J. (2000) Efficacy of intracoronary versus intravenous FGF-2 in a pig model of chronic myocardial ischemia. Annals of Thoracic Surgery, 70, 2113-2118.
26. Sato K., Wu T., Laham R.J., Johnson R.B., Douglas P., Li J., Sellke F.W., Bunting S., Simons M., and Post M.J. (2001) Efficacy of intracoronary or intravenous VEGF165 in a pig model of chronic myocardial ischemia. Journal of American College of Cardiology, 37, 616-623.
27. Semenza G.L. (2001) Hypoxia-inducible factor 1: Oxygen homeostasis and disease pathophysiology. Trends in Molecular Medicine, 7, 345-350.
28. Simons M., Annex B.H., Laham R.J., Kleiman N., Henry T., Dauerman H., Udelson J.E., Gervino E.V., Pike M., Whitehouse M.J., Moon T., and Chronos N.A. (2002) Pharmacological treatment of coronary artery disease with recombinant fibroblast growth factor-2: Double-blind, randomized, controlled clinical trial. Circulation, 105, 788-793.
29. Simons M., Bonow R.O., Chronos N.A., Cohen D.J., Giordano F.J., Hammond H.K., Laham R.J., Li W., Pike M., Sellke F.W., Stegmann T.J., Udelson J., and Rosengart T.K. (2000) Clinical trials in coronary angiogenesis: Issues, problems, consensus: An expert panel summary. Circulation, 102, E73-E86.
30. Simons M., and Post M. (2003) Angiogenesis. In Textbook of Interventional Cardiology (ed. E.J. Topol). W.B. Saunders, Philadelphia, pp. 757-779.
31. Tateishi-Yuyama E., Matsubara H., Murohara T., Ikeda U., Shintani S., Masaki H., Amano K., Kishimoto Y., Yoshimoto K., Akashi H., Shimada K., Iwasaka T., and Imaizumi T. (2002) Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: A pilot study and a randomised controlled trial. Lancet, 360, 427-435.
32. Tse H.F., Kwong Y.L., Chan J.K., Lo G., Ho C.L., and Lau C.P. (2003) Angiogenesis in ischaemic myocardium by intramyocardial autologous bone marrow mononuclear cell implantation. Lancet, 361, 47-49.
33. Unger E.F., Goncalves L., Epstein S.E., Chew E.Y., Trapnell C.B., Cannon R.O., 3rd, and Quyyumi A.A. (2000) Effects of a single intracoronary injection of basic fibroblast growth factor in stable angina pectoris. American Journal of Cardiology, 85, 1414-1419.