Gene therapy in critical limb ischemia

Vascular Disease Management

Volumn 6, Issue 4, 2009, Pages 118-124

  Keo, Hong H ^a   Hirsch, Alan T ^b   Baumgartner, Iris ^a   Nikol, Sigrid ^c   Henry, Timothy D ^b,d  

^a UNIVERSITY OF BERN   (Switzerland)

^b UNIVERSITY OF MINNESOTA   (United States)

^c Minneapolis Heart Institute Foundation Clinical Research ^*  (Germany)

^d MINNEAPOLIS HEART INSTITUTE FOUNDATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOGENIC FACTOR; ANGIOGENIN; ANGIOTROPIN; FIBROBLAST GROWTH FACTOR; FIBROBLAST GROWTH FACTOR 4; HYPOXIA INDUCIBLE FACTOR 1ALPHA; INTERLEUKIN 8; NAKED DNA; NON VIRAL FIBROBLAST GROWTH FACTOR; PLACENTAL GROWTH FACTOR; PLASMID DNA; PLASMID VECTOR; PLATELET DERIVED GROWTH FACTOR; PROLIFERIN; SCATTER FACTOR; SOMATOMEDIN; THROMBOCYTE ACTIVATING FACTOR; TRANSFORMING GROWTH FACTOR; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG; VASCULOTROPIN; VASCULOTROPIN 165; VIRUS VECTOR;

ABSENCE OF SIDE EFFECTS; ALLERGIC REACTION; ANGIOGENESIS; ARTERY DISEASE; ATHEROSCLEROSIS; CELL PROLIFERATION; CLINICAL TRIAL; CRITICAL LIMB ISCHEMIA; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; ENDOVASCULAR SURGERY; GENE THERAPY; GENE TRANSFER; GENETIC TRANSFECTION; HUMAN; HYPOTENSION; KAPLAN MEIER METHOD; LEG EDEMA; LIMB AMPUTATION; LIMB ISCHEMIA; NONVIRAL GENE THERAPY; OXYGEN CONCENTRATION; REVASCULARIZATION; REVIEW; STEM CELL; THERAPEUTIC ANGIOGENESIS; UNSPECIFIED SIDE EFFECT; VASCULAR DISEASE; VASCULAR LEAKAGE;

EID: 69349089177     PISSN: 15538036     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (47)

1. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): Executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol 2006;47:1239-1312.
2. Dormandy J, Mahir M, Ascady G, et al. Fate of the patient with chronic leg ischemia. A review article. J Cardiovasc Surg (Torino) 1989;30:50-57. (Pubitemid 19080681)
3. Dormandy J, Heeck L, Vig S. The fate of patients with critical leg ischemia. Semin Vasc Surg 1999;12:142-147. (Pubitemid 29259202)
4. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007;45:S5-S67. (Pubitemid 46151680)
5. Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: Results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation 2004;110:738-743.
6. Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Concensus (TASC). J Vasc Surg 2000;31:S1-S296.
7. Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): Multicenter, randomized controlled trial. Lancet 2005;366:1925-1934. (Pubitemid 41713982)
8. Lepantalo M, Matzke S. Outcome of unreconstructed chronic critical leg ischaemia. Eur J Vasc Endovasc Surg 1996;11:153-157. (Pubitemid 26120467)
9. Nikol S, Baumgartner I, Van Belle E, et al. Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia. Mol Ther 2008;16:972-978. (Pubitemid 351587109)
10. Folkman J. Tumor angiogenesis: Therapeutic implications. N Engl J Med 1971;285:1182-1186.
11. Takeshita S, Zheng LP, Brogi E, et al. Therapeutic angiogenesis. A single intraarterial bolus of vascular endothelial growth factor augments revascularization in a rabbit ischemic hind limb model. J Clin Invest 1994;93:662-670. (Pubitemid 24072807)
12. Lederman RJ, Mendelsohn FO, Anderson RD, et al. TheRapeutic Angiogenesis with recombinant Fibroblast growth Factor-2 for Intermittent Claudication (the TRAFFIC study): A randomised trial. Lancet 2002;359:2053-2058.
13. Lazarous DF, Unger EF, Epstein SE, et al. Basic fibroblast growth factor in patients with intermittent claudication: Results of a phase I trial. J Am Coll Cardiol 2000;36:1239-1244.
14. Yla-Herttuala S, Alitalo K. Gene transfer as a tool to induce therapeutic vascular growth. Nat Med 2003;9:694-701. (Pubitemid 36749218)
15. Dor Y, Djonov V, Abramovitch R, et al. Conditional switching of VEGF provides new insights into adult neovascularization and pro-angiogenic therapy. EMBO J 2002;21:1939-1947. (Pubitemid 34437191)
16. Baumgartner I, Chronos N, Comerota A, et al. Local gene transfer and expression following intramuscular administration of FGF-1 plasmid DNA in patients with critical limb ischemia. Mol Ther 2009;17:914-921.
17. Isner JM, Pieczek A, Schainfeld R, et al. Clinical evidence of angiogenesis following arterial gene transfer of phVEGF165 in a patient with ischemic limb. Lancet 1996;348:370-374. (Pubitemid 26261511)
18. Tongers J, Roncalli JG, Losordo DW. Therapeutic angiogenesis for critical limb ischemia: Microvascular therapies coming of age. Circulation 2008;118:9-16.
19. Henry TD, Abraham JA. Review of preclinical and clinical results with vascular endothelial growth factors for therapeutic angiogenesis. Curr Interv Cardiol Rep 2000;2:228-241.
20. Bobek V, Taltynov O, Pinterova D, Kolostova K. Gene therapy of the ischemic lower limb - Therapeutic angiogenesis. Vascul Pharmacol 2006;44:395-405. (Pubitemid 43766671)
21. Baumgartner I, Pieczek A, Manor O, et al. Constitutive expression of phVEGF165 following intramuscular gene transfer promotes collateral vessel development in patients with critical limb ischemia. Circulation 1998;97:1114-1123. (Pubitemid 28152883)
22. Galzie Z, Kinsella AR, Smith JA. Fibroblast growth factors and their receptors. Biochem Cell Biol 1997;75:669-685. (Pubitemid 127733222)
23. Gerwins P, Skoldenberg E, Claesson-Welsh L. Function of fibroblast growth factors and vascular endothelial growth factors and their receptors in angiogenesis. Crit Rev Oncol Hematol 2000;34:185-194. (Pubitemid 30320963)
24. Muhlhauser J, Pili R, Merrill MJ, et al. In vivo angiogenesis induced by recombinant adenovirus vectors coding either for secreted or nonsecreted forms of acidic fibroblast growth factor. Hum Gene Ther 1995;6:1457-1465.
25. Bruick RK, McKnight SL. A conserved family of prolyl-4-hydroxylases that modify HIF. Science 2001;294:1337-1340.
26. Ivan M, Kondo K, Yang H, et al. HIFalpha targeted for VHL-mediated destruction by proline hydroxylation: Implications for O2 sensing. Science 2001;292:464-468. (Pubitemid 32335941)
27. Wang GL, Semenza GL. Purification and characterization of hypoxia-inducible factor 1. J Biol Chem 1995;270:1230-1237.
28. Ho TK, Abraham DJ, Black CM, Baker DM. Hypoxia-inducible factor 1 in lower limb ischemia. Vascular 2006;14:321-327. (Pubitemid 46579398)
29. Aoki M, Morishita R, Taniyama Y, et al. Therapeutic angiogenesis induced by hepatocyte growth factor: Potential gene therapy for ischemic diseases. Journal theroscler Thromb 2000;7:71-76.
30. Isner JM, Baumgartner I, Rauh G, et al. Treatment of thrombangiitis obliterans (Buerger's disease) by intramuscular gene transfer of vascular endothelial growth factor: Preliminary clinical results. J Vasc Surg 1998;28:964-975. (Pubitemid 28562700)
31. Shyu K-G, Chang H, Wang B-W, P K. Intramuscular vascular endothelial growth factor (VEGF165) gene therapy in Chinese patients with chronic critical leg ischemia. Am J Med 2003;114:85-92. (Pubitemid 36183588)
32. Kusumanto YH, van Weel V, Mulder NH, et al. Treatment with intramuscular vascular endothelial growth factor gene compared with placebo for patients with diabetes mellitus and critical limb ischemia: A double-blind randomized trial. Hum Gene Ther 2006;17:683-691.
33. Makinen K, Manninen H, Hedman M, et al. Increased vascularity detected by digital subtraction angiography after VEGF gene transfer to human lower limb artery: A randomized, placebo-controlled, double-blinded phase II study. Mol Ther 2002;6:127-133. (Pubitemid 36124280)
34. Comerota AJ, Throm RC, Miller KA, et al. Naked plasmid DNA encoding fibroblast growth factor type 1 for the treatment of end-stage unreconstructible lower extremity ischemia: Preliminary results of a phase I trial. J Vasc Surg 2002;35:930-936.
35. Henry TD, Comerota A, Chronos N, et al. FGF-1 plasmid gene therapy for patients with critical limb ischemia: Final results. [Abstract]. J Am Coll Cardiol 2002;39:468B.
36. Henry TD, Mendelson F, Comerota A, et al. Dose and regimen effects of intramuscular NV1FGF in patients with critical limb ischemia: A randomized, double-blind, placebo-controlled study. [Abstract]. Eur Heart J 2006;27:235.
37. Matyas L, Schulte KL, Dormandy JA, et al. Arteriogenic gene therapy in patients with unreconstructable critical limb ischemia: A randomized, placebo-controlled clinical trial of adenovirus 5-delivered fibroblast growth factor-4. Hum Gene Ther 2005;16:1202-1211. (Pubitemid 41443712)
38. Rajagopalan S, Olin J, Deitcher S, et al. Use of a constitutively active hypoxia-inducible factor-1alpha transgene as a therapeutic strategy in no-option critical limb ischemia patients: Phase I dose-escalation experience. Circulation 2007;115:1234-1243. (Pubitemid 46594767)
39. Powell RJ, Simons M, Mendelsohn FO, et al. Results of a double-blind, placebo-controlled study to assess the safety of intramuscular injection of hepatocyte growth factor plasmid to improve limb perfusion in patients with critical limb ischemia. Circulation 2008;118:58-65.
40. A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia in Subjects Who Have Peripheral Ischemic Ulcers [NCT00189540]. http://www.clinicaltrials.gov/ct2/search. Last access, February 23, 2009.
41. Morishita R, Aoki M, Hashiya N, et al. Safety evaluation of clinical gene therapy using hepatocyte growth factor to treat peripheral arterial disease. Hypertension 2004;44:203-209. (Pubitemid 39014240)
42. Henry TD, Goldman J, Wang YL, et al. Hepatocyte growth factor gene therapy for patients with critical limb ischemia: Results of a phase I dose-escalation trial. J Am Coll Cardiol 2009: In press.
43. Baumgartner I, Rauh G, Pieczek A, et al. Lower-extremity edema associated with gene transfer of naked DNA encoding vascular endothelial growth factor. Ann Intern Med 2000;132:880-884. (Pubitemid 30346850)
44. Laitinen M, Hartikainen J, Hiltunen MO, et al. Catheter-mediated vascular endothelial growth factor gene transfer to human coronary arteries after angioplasty. Hum Gene Ther 2000;11:263-270. (Pubitemid 30080384)
45. Rissanen TT, Vajanto I, Yla-Herttuala S. Gene therapy for therapeutic angiogenesis in critically ischaemic lower limb - on the way to the clinic. Euro J Clin Invest 2001;31:651-666. (Pubitemid 32756613)
46. A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions [NCT00566657]. http://www. clinicaltrials.gov/ct2/search. Last access, 02.23.2009.
47. Sprengers RW, Lips DJ, Moll FL, Verhaar MC. Progenitor cell therapy in patients with critical limb ischemia without surgical options. Ann Surg 2008;247:411-420.