Safety and efficacy of patient specific 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

Journal of Vascular Surgery

Volumn 52, Issue 6, 2010, Pages 1525-1530

  Powell, Richard J ^a   Goodney, Phillip ^a   Mendelsohn, Farrell O ^b   Moen, Elaine K ^c   Annex, Brian H ^d  

^a DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^b Cardiology PC   (United States)

^c Care Group   (United States)

^d UNIVERSITY OF VIRGINIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SCATTER FACTOR;

AGED; ANGIOGENIC GENE THERAPY; ANKLE BRACHIAL INDEX; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GENE DELIVERY SYSTEM; HUMAN; INJECTION SITE DISCOMFORT; LEG AMPUTATION; LEG ISCHEMIA; LEG PAIN; LEG ULCER; LIMB PERFUSION; MALE; MULTICENTER STUDY; PAIN ASSESSMENT; PLASMID; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ULCER HEALING; VISUAL ANALOG SCALE; WOUND HEALING;

AGED; ANGIOGENESIS INDUCING AGENTS; ANKLE BRACHIAL INDEX; DOUBLE-BLIND METHOD; FEMALE; GENE THERAPY; HEPATOCYTE GROWTH FACTOR; HUMANS; INJECTIONS, INTRAMUSCULAR; ISCHEMIA; LEG; LEG ULCER; MALE; PAIN MEASUREMENT; PLASMIDS; ULTRASONOGRAPHY, DOPPLER, DUPLEX; WOUND HEALING;

EID: 78650184311     PISSN: 07415214     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jvs.2010.07.044     Document Type: Article

References (16)

1. D.J. Adam, J.D. Beard, T. Cleveland, J. Bell, A.W. Bradbury, J.F. Forbes BASIL trial participants Bypass versus angioplasty in severe ischemia of the leg (BASIL): multicentre, randomized controlled trial Lancet 366 2005 1925 1934
2. J. Dormandy, L. Heeck, and S. Vig The fate of subjects with critical leg ischemia Sem Vasc Surg 12 1999 142 147
3. M.H. Criqui, R.D. Langer, A. Fronek, H.S. Feigelson, M.R. Klauber, and T.J. McCann Mortality over a period of 10 years in patients with peripheral arterial disease New Engl J Med 326 1992 381 386
4. R.J. Powell, M. Simons, F.O. Mendelsohn, G. Daniel, T.D. Henry, and M. Koga 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 118 2008 58 65
5. Y. Taniyama, R. Morishita, M. Aoki, H. Nakagami, K. Yamamoto, and K. Yamazaki Therapeutic angiogenesis induced by human hepatocyte growth factor gene in rat and rabbit hind limb ischemia models: preclinical study for treatment of peripheral arterial disease Gen Ther 8 2001 181 189
6. R. Morishita, S. Nakamura, S. Hayashi, Y. Taniyama, A. Moriguchi, and T. Nagano Therapeutic angiogenesis induced by human recombinant hepatocyte growth factor in rabbit hind limb ischemia model as cytokine supplement therapy Hypertension 33 1999 1379 1384
7. R. Morishita, M. Aoki, Y. Yo, and T. Ogihara Hepatocyte growth factor as cardiovascular hormone: role of HGF in the pathogenesis of cardiovascular disease Endocr J 49 2002 273 284
8. H. Shigematsu, K. Yasuda, T. Iwai, T. Sasajima, S. Ishimaru, and Y. Ohashi Randomized, double-blind, placebo-controlled clinical trial of hepatocyte growth factor plasmid for critical limb ischemia Gene Ther 17 2010 1152 1161
9. K.A. Giles, F.B. Pomposelli, T.L. Spence, A.D. Hamdan, S.B. Blattman, and H. Panossian Infrapopliteal angioplasty for critical limb ischemia: relation of transatlantic intersociety concensus class to outcome in 176 limbs J Vasc Surg 48 2008 128 136
10. M. Conte, D. Bandyk, A. Clowes, G. Moneta, L. Seely, and T. Lorenz Results of PREVENT III: a multicenter, randomized trial of edifoligide for the prevention of vein graft failure in lower extremity bypass surgery J Vasc Surg 43 2006 742 751
11. S. Rajagopalan, J. Olin, S. Deitcher, A. Pieczek, J. Laird, and P.M. Grossman Use of a constitutively active hypoxia-inducible factor-1a transgene as a therapeutic strategy in no-option critical limb ischemia patients Circulation 115 2007 1234 1243
12. R.J. Lederman, F.O. Mendelsohn, R.D. Anderson, J.F. Saucedo, A.N. Tenaglia, J.B. Hermiller TRAFFIC Investigators Therapeutic angiogenesis with recombinant fibroblast growth factor-2 for intermittent claudication: the TRAFFIC study Lancet 359 2002 2053 2058
13. S. Nikol, I. Baumgartner, E. Van Belle, C. Diehm, A. Vison, M.C. Capogrossi TALISMAN 201 investigators Therapeutic angiogenesis with intramuscular NV1FGF improved amputation-free survival in patients with critical limb ischemia Mol Ther 16 2008 972 978
14. I. Baumgartner, N. Chronos, A. Camerota, T. Henry, J.P. Pasquet, and F. Finiels Local gene transfer and expression following intramuscular administration of FGF-1 plasmid DNA in patients with critical limb ischemia Mol Ther 17 2009 914 921
15. L. Norgren, W.R. Hiatt, J.A. Dormandy, M.R. Nehler, K.A. Harris, F.G. Fowkes TASC II Working Group Trans-Atlantic Inter-society Consensus for the Management of Peripheral Arterial Disease (TASC II) Eur J Vasc Endovasc Surg 33 Suppl1 2007 S1 S75
16. M.S. Conte, P.J. Geraghty, A.W. Bradbury, N.D. Hevelone, S.R. Lipsitz, and G.L. Moneta Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia J Vasc Surg 50 2009 1462 1473 e1-3