Long-term follow-up evaluation of results from clinical trial using hepatocyte growth factor gene to treat severe peripheral arterial disease

Arteriosclerosis, Thrombosis, and Vascular Biology

Volumn 32, Issue 10, 2012, Pages 2503-2509

  Makino, Hirofumi ^a   Aoki, Motokuni ^b   Hashiya, Naotaka ^a   Yamasaki, Keita ^a   Azuma, Junya ^a   Sawa, Yoshiki ^a   Kaneda, Yasufumi ^a   Ogihara, Toshio ^b   Morishita, Ryuichi ^a  

^a OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b MORINOMIYA UNIVERSITY OF MEDICAL SCIENCES   (Japan)

Author keywords

angiogenesis; gene therapy; hepatocyte growth factor; peripheral arterial disease; plasmid DNA

Indexed keywords

NAKED DNA; PLASMID DNA; PLASMID VECTOR; SCATTER FACTOR;

ABSENCE OF SIDE EFFECTS; ADULT; AGED; ANKLE BRACHIAL INDEX; ARTICLE; BUERGER DISEASE; CLINICAL ARTICLE; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; IN VIVO GENE TRANSFER; INJECTION; INTERMITTENT CLAUDICATION; LEG ULCER; LIMB ISCHEMIA; LONG TERM CARE; MALE; NONVIRAL GENE DELIVERY SYSTEM; NONVIRAL GENE THERAPY; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; VISUAL ANALOG SCALE;

ADULT; AGED; AMPUTATION; FEMALE; FOLLOW-UP STUDIES; GENETIC THERAPY; HEPATOCYTE GROWTH FACTOR; HUMANS; INCIDENCE; INJECTIONS, INTRAMUSCULAR; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; PAIN MEASUREMENT; PERIPHERAL ARTERIAL DISEASE; PLASMIDS; SURVIVAL RATE; THROMBOANGIITIS OBLITERANS; TREATMENT OUTCOME;

EID: 84866620149     PISSN: 10795642     EISSN: 15244636     Source Type: Journal    
DOI: 10.1161/ATVBAHA.111.244632     Document Type: Article

References (27)

1. Isner JM, Pieczek A, Schainfeld R, Blair R, Haley L, Asahara T, Rosenfeld K, Razvi S, Walsh K, Symes JF. Clinical evidence of angio-genesis after arterial gene transfer of phVEGF165 in patient with isch-aemic limb. Lancet. 1996;348:370-374.
2. Baumgartner I, Pieczek A, Manor O, Blair R, Kearney M, Walsh K, Isner JM. Constitutive expression of phVEGF165 after intramuscular gene transfer promotes collateral vessel development in patients with critical limb ischemia. Circulation. 1998;97:1114-1123.
3. Losordo DW, Vale PR, Symes JF, Dunnington CH, Esakof DD, Maysky M, Ashare AB, Lathi K, Isner JM. Gene therapy for myocardial angio-genesis: initial clinical results with direct myocardial injection of phVEGF165 as sole therapy for myocardial ischemia. Circulation. 1998;98:2800-2804.
4. Baumgartner I, Rauh G, Pieczek A, Wuensch D, Magner M, Kearney M, Schainfeld R, Isner JM. Lower-extremity edema associated with gene transfer of naked DNA encoding vascular endothelial growth factor. Ann Intern Med. 2000;132:880-884.
5. Rajagopalan S, Mohler ER 3rd, Lederman RJ, Mendelsohn FO, Saucedo JF, Goldman CK, Blebea J, Macko J, Kessler PD, Rasmussen HS, Annex BH. Regional angiogenesis with vascular endothelial growth factor in peripheral arterial disease: a phase II randomized, double-blind, controlled study of adenoviral delivery of vascular endothelial growth factor 121 in patients with disabling intermittent claudication. Circulation. 2003;108:1933-1938.
6. 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.
7. Belch J, Hiatt WR, Baumgartner I, Driver IV, Nikol S, Norgren L, Van Belle E; TAMARIS Committees and Investigators. Effect of fbroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011;377:1929-1937.
8. Morishita R, Nakamura S, Hayashi S, Taniyama Y, Moriguchi A, Nagano T, Taiji M, Noguchi H, Takeshita S, Matsumoto K, Nakamura T, Higaki J, Ogihara T. Therapeutic angiogenesis induced by human recombinant hepatocyte growth factor in rabbit hind limb ischemia model as cytokine supplement therapy. Hypertension. 1999;33:1379-1384.
9. Hayashi S, Morishita R, Nakamura S, Yamamoto K, Moriguchi A, Nagano T, Taiji M, Noguchi H, Matsumoto K, Nakamura T, Higaki J, Ogihara T. Potential role of hepatocyte growth factor, a novel angiogenic growth factor, in peripheral arterial disease: downregulation of HGF in response to hypoxia in vascular cells. Circulation. 1999;100:II301-II308.
10. Taniyama Y, Morishita R, Aoki M, Nakagami H, Yamamoto K, Yamazaki K, Matsumoto K, Nakamura T, Kaneda Y, Ogihara T. Therapeutic angiogenesis induced by human hepatocyte growth factor gene in rat and rabbit hindlimb ischemia models: preclinical study for treatment of peripheral arterial disease. Gene Ther. 2001;8:181-189.
11. Aoki M, Morishita R, Taniyama Y, Kida I, Moriguchi A, Matsumoto K, Nakamura T, Kaneda Y, Higaki J, Ogihara T. Angiogenesis induced by hepatocyte growth factor in non-infarcted myocardium and infarcted myocardium: up-regulation of essential transcription factor for angio-genesis, ets. Gene Ther. 2000;7:417-427.
12. Taniyama Y, Morishita R, Hiraoka K, Aoki M, Nakagami H, Yamasaki K, Matsumoto K, Nakamura T, Kaneda Y, Ogihara T. Therapeutic angio-genesis induced by human hepatocyte growth factor gene in rat diabetic hind limb ischemia model: molecular mechanisms of delayed angiogen-esis in diabetes. Circulation. 2001;104:2344-2350.
13. Morishita R, Sakaki M, Yamamoto K, Iguchi S, Aoki M, Yamasaki K, Matsumoto K, Nakamura T, Lawn R, Ogihara T, Kaneda Y. Impairment of collateral formation in lipoprotein(a) transgenic mice: therapeutic angiogenesis induced by human hepatocyte growth factor gene. Circulation. 2002;105:1491-1496.
14. Azuma J, Taniyama Y, Takeya Y, Iekushi K, Aoki M, Dosaka N, Matsumoto K, Nakamura T, Ogihara T, Morishita R. Angiogenic and anti-fbrotic actions of hepatocyte growth factor improve cardiac dysfunction in porcine ischemic cardiomyopathy. Gene Ther. 2006;13:1206-1213.
15. Nakamura Y, Morishita R, Higaki J, Kida I, Aoki M, Moriguchi A, Yamada K, Hayashi S, Yo Y, Nakano H, Matsumoto K, Nakamura T, Ogihara T. Hepatocyte growth factor is a novel member of the endothe-lium-specifc growth factors: additive stimulatory effect of hepatocyte growth factor with basic fbroblast growth factor but not with vascular endothelial growth factor. J Hypertens. 1996;14:1067-1072.
16. Morishita R, Aoki M, Hashiya N, Makino H, Yamasaki K, Azuma J, Sawa Y, Matsuda H, Kaneda Y, Ogihara T. Safety evaluation of clinical gene therapy using hepatocyte growth factor to treat peripheral arterial disease. Hypertension. 2004;44:203-209.
17. Morishita R, Makino H, Aoki M, Hashiya N, Yamasaki K, Azuma J, Taniyama Y, Sawa Y, Kaneda Y, Ogihara T. Phase I/IIa clinical trial of therapeutic angiogenesis using hepatocyte growth factor gene transfer to treat critical limb ischemia. Arterioscler Thromb Vasc Biol. 2011;31: 713-720.
18. Shigematsu H, Yasuda K, Iwai T, Sasajima T, Ishimaru S, Ohashi Y, Yamaguchi T, Ogihara T, Morishita R. Randomized, double-blind, placebo-controlled clinical trial of hepatocyte growth factor plasmid for critical limb ischemia. Gene Ther. 2010;17:1152-1161.
19. Powell RJ, Simons M, Mendelsohn FO, Daniel G, Henry TD, Koga M, Morishita R, Annex BH. 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.
20. Powell RJ, Goodney P, Mendelsohn FO, Moen EK, Annex BH; HGF-0205 Trial Investigators. Safety and effcacy of patient specifc intramuscular injection of HGF plasmid gene therapy on limb perfusion and wound healing in patients with ischemic lower extremity ulceration: results of the HGF-0205 trial. J Vasc Surg. 2010;52:1525-1530.
21. Hashiya N, Jo N, Aoki M, Matsumoto K, Nakamura T, Sato Y, Ogata N, Ogihara T, Kaneda Y, Morishita R. In vivo evidence of angiogenesis induced by transcription factor Ets-1: Ets-1 is located upstream of angio-genesis cascade. Circulation. 2004;109:3035-3041.
22. Saito Y, Nakagami H, Morishita R, Takami Y, Kikuchi Y, Hayashi H, Nishikawa T, Tamai K, Azuma N, Sasajima T, Kaneda Y. Transfection of human hepatocyte growth factor gene ameliorates secondary lymphedema via promotion of lymphangiogenesis. Circulation. 2006;114:1177-1184.
23. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5-67.
24. Global Lower Extremity Amputation Study Group. Epidemiology of lower extremity amputation in centres in Europe, North America and East Asia.The Global Lower Extremity Amputation Study Group. Br J Surg. 2000;87:328-337.
25. Shigematsu H, Yasuda K, Tanabe T. The 20th annual meeting of Japanese Society for Vascular Surgery. Therapeutic Research. 1992;13:4099-4109.
26. Kumakura H, Kanai H, Aizaki M, Mitsui K, Araki Y, Kasama S, Iwasaki T, Ichikawa S. The infuence of the obesity paradox and chronic kidney disease on long-term survival in a Japanese cohort with peripheral arterial disease. J Vasc Surg. 2010;52:110-117.
27. Matoba S, Tatsumi T, Murohara T, Imaizumi T, Katsuda Y, Ito M, Saito Y, Uemura S, Suzuki H, Fukumoto S, Yamamoto Y, Onodera R, Teramukai S, Fukushima M, Matsubara H; TACT Follow-up Study Investigators. Long-term clinical outcome after intramuscular implantation of bone marrow mononuclear cells (Therapeutic Angiogenesis by Cell Transplantation [TACT] trial) in patients with chronic limb ischemia. Am Heart J. 2008;156:1010-1018.