Cited 29 times in
Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia
DC Field | Value | Language |
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dc.contributor.author | 최동훈 | - |
dc.date.accessioned | 2017-02-24T08:14:38Z | - |
dc.date.available | 2017-02-24T08:14:38Z | - |
dc.date.issued | 2016 | - |
dc.identifier.issn | 0969-7128 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/146594 | - |
dc.description.abstract | VM202, a plasmid DNA that expresses two isoforms of hepatocyte growth factor, may elicit angiogenic effects that could benefit patients with critical limb ischemia (CLI). In a phase 2, double-blind trial in 52 CLI patients, we examined the safety and potential efficacy of intramuscular injections of low-dose (n=21) or high-dose (n=20) VM202 or placebo (n=11) in the affected limb (days 0, 14, 28 and 42). Adverse events and serious adverse events were similar among the groups; no malignancy or proliferative retinopathy was seen. In exploratory efficacy analyses, we found no differences in ankle or toe-brachial index, VAS, VascuQuol or amputation rate among the groups. Complete ulcer healing was significantly better in high-dose (8/13 ulcers; P<0.01) versus placebo (1/9) patients. Clinically meaningful reductions (>50%) in ulcer area occurred in high-dose (9/13 ulcers) and low-dose (19/27) groups versus placebo (1/9; P<0.05 and P<0.005, respectively). At 12 months, significant differences were seen in TcPO2 between the high-dose and placebo groups (47.5 ± 17.8 versus 36.6 ± 24.0 mm Hg, respectively; P<0.05) and in the change from baseline among the groups (P<0.05). These data suggest that VM202 is safe and may provide therapeutic bioactivity in CLI patients. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.format.extent | 306~312 | - |
dc.language | English | - |
dc.publisher | Nature Publishing Group | - |
dc.relation.isPartOf | GENE THERAPY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Extremities/blood supply* | - |
dc.subject.MESH | Extremities/injuries* | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Genetic Vectors/adverse effects* | - |
dc.subject.MESH | Hepatocyte Growth Factor/adverse effects* | - |
dc.subject.MESH | Hepatocyte Growth Factor/genetics* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Plasmids/adverse effects | - |
dc.subject.MESH | Protein Isoforms/adverse effects | - |
dc.subject.MESH | Protein Isoforms/genetics | - |
dc.title | Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia | - |
dc.type | Article | - |
dc.publisher.location | England | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | MR Kibbe | - |
dc.contributor.googleauthor | AT Hirsch | - |
dc.contributor.googleauthor | FO Mendelsohn | - |
dc.contributor.googleauthor | MG Davies | - |
dc.contributor.googleauthor | H Pham | - |
dc.contributor.googleauthor | J Saucedo | - |
dc.contributor.googleauthor | W Marston | - |
dc.contributor.googleauthor | W-B Pyun | - |
dc.contributor.googleauthor | S-K Min | - |
dc.contributor.googleauthor | BG Peterson | - |
dc.contributor.googleauthor | A Comerota | - |
dc.contributor.googleauthor | D Choi | - |
dc.contributor.googleauthor | J Ballard | - |
dc.contributor.googleauthor | RA Bartow | - |
dc.contributor.googleauthor | DW Losordo | - |
dc.contributor.googleauthor | W Sherman | - |
dc.contributor.googleauthor | V Driver | - |
dc.contributor.googleauthor | EC Perin | - |
dc.identifier.doi | 10.1038/gt.2015.110 | - |
dc.contributor.localId | A04053 | - |
dc.relation.journalcode | J00924 | - |
dc.identifier.eissn | 1476-5462 | - |
dc.identifier.pmid | 26649448 | - |
dc.identifier.url | http://www.nature.com/gt/journal/v23/n3/full/gt2015110a.html | - |
dc.contributor.alternativeName | Choi, Dong Hoon | - |
dc.contributor.affiliatedAuthor | Choi, Dong Hoon | - |
dc.citation.volume | 23 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 306 | - |
dc.citation.endPage | 312 | - |
dc.identifier.bibliographicCitation | GENE THERAPY, Vol.23(3) : 306-312, 2016 | - |
dc.date.modified | 2017-02-24 | - |
dc.identifier.rimsid | 46403 | - |
dc.type.rims | ART | - |
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