Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 편욱범 | * |
dc.date.accessioned | 2016-08-27T04:08:59Z | - |
dc.date.available | 2016-08-27T04:08:59Z | - |
dc.date.issued | 2016 | * |
dc.identifier.issn | 0969-7128 | * |
dc.identifier.issn | 1476-5462 | * |
dc.identifier.other | OAK-16604 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/218093 | - |
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 (450%) 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.language | English | * |
dc.publisher | NATURE PUBLISHING GROUP | * |
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.relation.issue | 3 | * |
dc.relation.volume | 23 | * |
dc.relation.index | SCI | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 306 | * |
dc.relation.lastpage | 312 | * |
dc.relation.journaltitle | GENE THERAPY | * |
dc.identifier.doi | 10.1038/gt.2015.110 | * |
dc.identifier.wosid | WOS:000371829200008 | * |
dc.identifier.scopusid | 2-s2.0-84960128755 | * |
dc.author.google | Kibbe, M. R. | * |
dc.author.google | Hirsch, A. T. | * |
dc.author.google | Mendelsohn, F. O. | * |
dc.author.google | Davies, M. G. | * |
dc.author.google | Pham, H. | * |
dc.author.google | Saucedo, J. | * |
dc.author.google | Marston, W. | * |
dc.author.google | Pyun, W-B | * |
dc.author.google | Min, S-K | * |
dc.author.google | Peterson, B. G. | * |
dc.author.google | Comerota, A. | * |
dc.author.google | Choi, D. | * |
dc.author.google | Ballard, J. | * |
dc.author.google | Bartow, R. A. | * |
dc.author.google | Losordo, D. W. | * |
dc.author.google | Sherman, W. | * |
dc.author.google | Driver, V. | * |
dc.author.google | Perin, E. C. | * |
dc.contributor.scopusid | 편욱범(6508352922) | * |
dc.date.modifydate | 20240123092816 | * |