Safety Evaluation of Clinical Gene Therapy Using Hepatocyte Growth Factor to Treat Peripheral Arterial Disease
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- Ryuichi Morishita
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Motokuni Aoki
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Naotaka Hashiya
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Hirofumi Makino
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Keita Yamasaki
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Junya Azuma
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Yoshiki Sawa
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Hikaru Matsuda
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Yasufumi Kaneda
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
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- Toshio Ogihara
- From the Department of Geriatric Medicine (R.M., M.A., N.H., H.M., K.Y., J.A., T.O.), Division of Clinical Gene Therapy (R.M.), Department of Surgery (Y.S., H.M.), and Division of Gene Therapy Science (Y.K.), Graduate School of Medicine, Osaka University, Japan.
書誌事項
- 公開日
- 2004-08
- 資源種別
- journal article
- DOI
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- 10.1161/01.hyp.0000136394.08900.ed
- 公開者
- Ovid Technologies (Wolters Kluwer Health)
この論文をさがす
説明
<jats:p>Therapeutic angiogenesis using angiogenic growth factors is expected to be a new treatment for patients with critical limb ischemia (CLI). Because hepatocyte growth factor (HGF) has potent angiogenic activity, we investigated the safety and efficiency of HGF plasmid DNA in patients with CLI as a prospective open-labeled clinical trial. Intramuscular injection of naked HGF plasmid DNA was performed in ischemic limbs of 6 CLI patients with arteriosclerosis obliterans (n=3) or Buerger disease (n=3) graded as Fontaine III or IV. The primary end points were safety and improvement of ischemic symptoms at 12 weeks after transfection. Severe complications and adverse effects caused by gene transfer were not detected in any patients. Of particular importance, no apparent edema was observed in any patient throughout the trial. In addition, serum HGF concentration was not changed throughout the therapy period in all patients. In contrast, a reduction of pain scale of more than 1 cm in visual analog pain scale was observed in 5 of 6 patients. Increase in ankle pressure index more than 0.1 was observed in 5 of 5 patients. The long diameter of 8 of 11 ischemic ulcers in 4 patients was reduced >25%. Intramuscular injection of naked HGF plasmid is safe, feasible, and can achieve successful improvement of ischemic limbs. Although the present data are conducted to demonstrate the safety as phase I/early phase IIa, the initial clinical outcome with HGF gene transfer seems to indicate usefulness as sole therapy for CLI.</jats:p>
収録刊行物
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- Hypertension
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Hypertension 44 (2), 203-209, 2004-08
Ovid Technologies (Wolters Kluwer Health)
