| Selective and sustained delivery of basic fibroblast growth factor (bFGF) for treatment of peripheral arterial disease: results of a phase I trial. | |
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MedLine Citation:
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PMID: 19328029 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVES: The aim of this study was to evaluate the safety of selective and sustained delivery of basic fibroblast growth factor (bFGF) using acidic gelatine hydrogel microspheres (AGHMs) for the treatment of peripheral arterial disease (PAD). MATERIALS AND METHODS: We conducted a non-randomised and uncontrolled trial involving prospective observation of eight patients (eight limbs) with PAD - five limbs with arteriosclerosis obliterans and three limbs with thromboangiitis obliterans, five limbs (three arms and two legs) with critical limb ischaemia (CLI) and three limbs with intermittent claudication (IC) - who were followed up for 6 months or more. AGHM suspension containing 100 microg bFGF was infused into the artery of the affected limb. Besides evaluation of safety and changes in symptoms, resting ankle-brachial pressure index measurement and transcutaneous PO(2) (tcPO(2)), angiography were conducted at baseline and then at various time points. Skin perfusion pressure as an index of CLI and claudication distance as an index of IC were also used to assess clinical improvement and limb perfusion. RESULTS: No serious adverse events were observed. All cases showed improvement in symptoms, although this was temporary in some patients. CONCLUSION: Selective delivery of bFGF using AGHMs was suggested to be safe and well-tolerated in patients with PAD. |
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Authors:
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T Hashimoto; H Koyama; T Miyata; A Hosaka; Y Tabata; T Takato; H Nagawa |
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Publication Detail:
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Type: Clinical Trial, Phase I; Comparative Study; Journal Article; Research Support, Non-U.S. Gov't Date: 2009-03-26 |
Journal Detail:
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Title: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery Volume: 38 ISSN: 1532-2165 ISO Abbreviation: Eur J Vasc Endovasc Surg Publication Date: 2009 Jul |
Date Detail:
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Created Date: 2009-06-15 Completed Date: 2009-06-30 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9512728 Medline TA: Eur J Vasc Endovasc Surg Country: England |
Other Details:
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Languages: eng Pagination: 71-5 Citation Subset: IM |
Affiliation:
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Division of Vascular Surgery, Department of Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Angiography Arteriosclerosis Obliterans / drug therapy, physiopathology, radiography Blood Pressure / drug effects, physiology Delayed-Action Preparations Female Fibroblast Growth Factor 2 / administration & dosage* Follow-Up Studies Humans Injections, Intra-Arterial Intermittent Claudication / drug therapy, physiopathology, radiography Male Microspheres Middle Aged Peripheral Vascular Diseases / drug therapy*, physiopathology, radiography Prospective Studies Thromboangiitis Obliterans / drug therapy, physiopathology, radiography Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Delayed-Action Preparations; 103107-01-3/Fibroblast Growth Factor 2 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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