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Clinical Trials Using Non-viral Gene Delivery Systems

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Non-viral Gene Therapy

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References

  • Baumgartner I, Pieczek A, Manor O (1998) Constitutive expression of phVEGF 165 after intramusclar gene transfer promotes collateral vessel development in patients with critical limb ischemia. Circulation 97:1114–1123

    CAS  PubMed  Google Scholar 

  • Baumgartner I, Rauh G, Pieczek A (2000) Lower-extremity edema associated with gene transfer of naked DNA encoding vascular endotherial growth factor. Ann Intern med 132:880–884

    CAS  PubMed  Google Scholar 

  • Bocchia M, Bronte V, Colombo MP, De Vincentiis A, Di Nicola M, Forni G, Lanata L, Lemoli RM, Massaia M, Rondelli D, Zanon P, Tura S (2000) Antitumor vaccination: where we stand. Haematologica 85:1172–1206

    CAS  PubMed  Google Scholar 

  • Clark PR, Stopeck AT, Ferrari M, Parker SE, Hersh EM (2000) Studies of direct intratumoral gene transfer using cationic lipid-complexed plasmid DNA. Cancer Gene Ther 7:853–860

    Article  CAS  PubMed  Google Scholar 

  • Comerota AJ, Throm RC, Miller KA (2002) Naked plasmid DNA encoding fibroblast growth factor type I for the treatment of end-stage unreconstructible lower extremity ischemia: preliminary results of a phase I trial. J Vasc Surg 35:930–936

    Article  PubMed  Google Scholar 

  • D’Urso CM, Wang ZG, Cao Y, Tatake R, Zeff RA, Ferrone S (1991) Lack of HLA class I antigen expression by cultured melanoma cell FO-1 due to a defect in B2m gene expression. J Clin Investig 87:284–292

    CAS  PubMed  Google Scholar 

  • Felgner PL, Gadek TR, Holm M, Roman R, Chan HW, Wenz M, Northrop JR, Ringold GM, Danielson M (1987) Lipofection: A highly efficient, lipid-mediated DNA-transfection procedure. Proc Natl Acad Sci USA 84:7413–7414

    CAS  PubMed  Google Scholar 

  • Felgner PL, Ringold GM (1989) Cationic liposome-mediated transfection. Nature 337:387–388

    Article  CAS  PubMed  Google Scholar 

  • Galanis E (2002) Technology evaluation: Allovectin-7, Vical, Curr Opin Mol Ther 4(1):80–87

    CAS  PubMed  Google Scholar 

  • Gene Therapy Clinical Trials Worldwide (www.wiley.co.uk/genmed/clinical), The Journal of Gene Medicine, 2004

    Google Scholar 

  • Hersh EM, Stopeck AT, Unger EC, Warneke JA, Silver HK, Klasa R, Doroshow JH, Rubin J, Galanis E, Rhinehart JJ (2001) Phase II study of intratumoral gene transfer of Allovectin-7 (plasmid DNA encoding HLA-B7 complexed with cationic lipid) in HLA-B7 negative patients with metastatic melanoma. Cancer Gene Ther

    Google Scholar 

  • Isner JM, Walsh K, Rosenfield K (1996) Clinical protocol: arterial gene therapy for restenosis. Human Gene Ther 7:989–1011

    CAS  Google Scholar 

  • Isner JM, Baumgartner I, Rauh G (1998) Treatment of thromboangiitis obliterans (Buerger’s disease) by intramusclar gene transfer of vascular endothelial growth factor: preliminary clinical results. J Vasc Surg 28:964–973

    Article  CAS  PubMed  Google Scholar 

  • Krieg AM, Yi AK, Matson S, Waldschmidt TJ, Bishop GA, Teasdale R, Koretzky GA, Klinman DM (1995) CpG motifs in bacterial DNA trigger direct B-cell activation. Nature 374:546–549

    Article  CAS  PubMed  Google Scholar 

  • Lathi KG, Vale PR, Losordo DW (2001) Gene therapy with vascular endothelial growth factor for inoperable coronary artery disease: anesthetic management and results. Anesth Analg 92:19–25

    CAS  PubMed  Google Scholar 

  • Latinen M, Hartikainen J, Hiltunen MO (2000) Catheter-mediated vascular endothelial growth factor gene transfer to human coronary arteries after angioplasty. Human gene Ther 11:263–270

    Google Scholar 

  • Losordo DW, Vale PR, Symes JF (1998) Gene therapy for myocardial angiogenesis: initial clinical results with direct myocardial injection of phVEGF 165 as sole therapy for myocardial ischemia. Circulation 98:2800–2804

    CAS  PubMed  Google Scholar 

  • Makinen K, Manninen H, Hedman M (2002) 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 6:127–133

    Article  CAS  PubMed  Google Scholar 

  • Mann MJ, Whitemore AD, Donaldson MC (1999) Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy: the PREVENT single-centre, randomized, controlled trial. Lancer 354:1493–1498

    Article  CAS  Google Scholar 

  • Mizuno M, Yoshida J (1998) Effect of human interferon-β gene transfer upon human glioma transplanted into nude mouse brain involves induced natural killer cells. Cancer Immunol Immunother 47:227–232

    Article  CAS  PubMed  Google Scholar 

  • Morishita R, Higaki J, Tomita N, Ogihara T (1998) Application of transcription factor “decoy” strategy as means of gene therapy and study of gene expression in cardiovascular disease. Circ Res 82:1023–102

    CAS  PubMed  Google Scholar 

  • Morishita R (2004a) Perspective in progress of cardiovascular Gene Therapy. J Pharmacol Sci 95:1–8

    Article  CAS  PubMed  Google Scholar 

  • Morishita R, Aoki M, Hashiya N, Makino H, Yamasaki K, Azuma J, Sawa Y, Matsuda H, Kaneda Y, Ogihara T (2004b) Safety evaluation of clinical gene therapy using hepatocyte growth factor to treat peripheral arterial disease. Hypertension 44:203–209

    CAS  PubMed  Google Scholar 

  • Nabel GJ, Nabel EG, Yang ZY, Fox BA, Plautz GE, Gao X, Huang L, Shu S, Gordon D, Chang AE (1993a) Direct gene transfer with DNA-liposome complexes in melanoma: expression, biologic activity, and lack of toxicity in humans. Proc Natl Acad Sci USA 90:11307–11311

    CAS  PubMed  Google Scholar 

  • Nabel EG, Nabel GJ (1993b) Direct gene transfer: basic studies and human therapies. Thromb Haemostasis 70:202–203

    CAS  Google Scholar 

  • Natsume A, Mizuno M, Ryuke Y, Yoshida J (1999) Antitumor effect and cellular immunity activation by nature interferon-β gene transfer against intracerebral glioma in mouse. Gene Ther 6:1626–1633

    Article  CAS  PubMed  Google Scholar 

  • Natsume A, Tsujimura K, Mizuno M, Takahashi T, Yoshida J (2000) IFN-β gene therapy induces systemic antitumor immunity against malignant glioma. J Neurooncol 47:117–124

    Article  CAS  PubMed  Google Scholar 

  • Roman M, Martin-Orozco E, Goodman JS, Nguyen MD, Sato Y, Ronaghy A, Kornbluth RS, Richman DD, Carson DA, Raz E (1997) Immunostimulatory DNA sequences function as T helper-1-promoting adjuvants. Nat Med 3:849–854

    Article  CAS  PubMed  Google Scholar 

  • Rosengart TK, Lee LY, Patel Sr, Sanborn TA, Parikh M, Bergman GW, Hachamovitch R, Szulc M, Kligfield PD, Okin PM, Hahn RT, Devereux RB, Post MR, Hackett NR, Foster T, Grasso TM, Lesser ML, Isom OW, Crystal RG (1999a) Angiogenesis gene therapy: phase I assessment of direct intramyocardial administration of an adenovirus vector expressing VEGF 121 cDNA to individuals with clinically significant severe coronary artery disease. Circulation 100:468–474

    CAS  PubMed  Google Scholar 

  • Rosengart TK, Lee LY, Patel SR, Kligfield PD, Okin PM, Hackett NR, Isom OW, Crystal RG (1999b) Six-month assessment of a phase I trial of angiogenic gene therapy for the treatment of coronary artery disease using direct intramyocardial administration of an adenovirus vector expressing the VEGF 121 cDNA. Ann Surg 230:466–470

    Article  CAS  PubMed  Google Scholar 

  • Rubin J, Galanis E, Pitot HC, Richardson RL, Burch PA, Charboneau JW, Reading CC, Lewis BD, Starhl S, Akporiaye ET, Harris DT (1997) Phase I study of immunotherapy of hepatic metastases of colorectal carcinoma by direct gene transfer of an allogenic histocompatibility antigen, HLA-B7. Gene Therapy 4(5):419–425

    Article  CAS  PubMed  Google Scholar 

  • Stopeck AT, Nicholson AC, Mancini FP, Hajjar DP (1993) Cytokine regulation of low density lipoprotein receptor gene transcription in HepG2 cells. J Biol Chem 268:17489–17494

    CAS  PubMed  Google Scholar 

  • Stopeck AT, Hersh EM, Akporiaye ET, Harris DT, Grogan T, Unger E, Warneke J, Schluter SF, Stahl S (1997) Phase I study of direct gene transfer of an allogenic histocompatibility antigen, HLA-B7, in patients with metastatic melanoma. J Clin Oncol 15:341–349

    CAS  PubMed  Google Scholar 

  • Stopeck AT, Jones A, Hersh EM, Thompson JA, Finucane DM, Gutheil JC, Gonzalez R (2001) Phase II Study of direct intralesional gene transfer of Allovectin-7, an HLA-B7/ββ2-microglobulin DNA-liposome complex, in patients with metastatic melanoma. Clinical Cancer Research 7:2285–2291

    CAS  PubMed  Google Scholar 

  • Taniyama Y, Morishita R, Aoki M, Nakagami H, Yamamoto K, Yamazaki K, Matsumoto K, Nakamura T, Kaneda Y, Ogihara T (2001) 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. Gene Ther 8:181–189

    Article  CAS  PubMed  Google Scholar 

  • Vale PR, Losordo DW, Milliken CE (2000) Left ventricular electromechanical mapping to assess efficacy of phVEGF 165 gene transfer for therapeutic angiogenesis in chronic myocardial ischemia. Circulation 102:965–974

    CAS  PubMed  Google Scholar 

  • Yagi K, Noda H, Kurono M, Ohishi N (1993) Efficient gene transfer with less than cytotoxicity by means of cationic multilamellar liposomes. Biochem Biophys Res Commun 196:1042–1048

    Article  CAS  PubMed  Google Scholar 

  • Yoshida J, Mizuno M, Yagi K (1992a) Cytotoxicity of human β-interferon produced human glioma cells transfected with its gene by means of liposomes. Biochemistry International 28:1055–1061

    CAS  PubMed  Google Scholar 

  • Yoshida J, Mizuno M, Yagi K (1992b) Antitumor effect of endogenous human β-interferon on malignant glioma and augmentation of the effect by tumor necrosis factor-a. J Clin Biochem Nutr 77:78–83

    CAS  Google Scholar 

  • Yoshida J, Mizuno M (2003) Clinical gene therapy for brain tumors. Liposomal delivery of anticancer molecule to glioma. J Neuro-Oncology 65:261–267

    Google Scholar 

  • Yoshida J, Mizuno M, Fujii M, Kajita Y, Nakahara N, hatano M, Saito R, Nobayashi M, Wakabayashi T (2004) Human gene therapy for malignant gliomas (glioblastoma multifirme and anaplastic astrocytoma) by in vivo transduction with human interferon β gene using cationic liposomes. Human Gene Therapy 15:77–86

    Article  CAS  PubMed  Google Scholar 

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© 2005 Springer-Verlag Tokyo

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Yanagie, H. (2005). Clinical Trials Using Non-viral Gene Delivery Systems. In: Taira, K., Kataoka, K., Niidome, T. (eds) Non-viral Gene Therapy. Springer, Tokyo. https://doi.org/10.1007/4-431-27879-6_21

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