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Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia

Title
Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia
Authors
Kibbe, M. R.Hirsch, A. T.Mendelsohn, F. O.Davies, M. G.Pham, H.Saucedo, J.Marston, W.Pyun, W-BMin, S-KPeterson, B. G.Comerota, A.Choi, D.Ballard, J.Bartow, R. A.Losordo, D. W.Sherman, W.Driver, V.Perin, E. C.
Ewha Authors
편욱범
SCOPUS Author ID
편욱범scopus
Issue Date
2016
Journal Title
GENE THERAPY
ISSN
0969-7128JCR Link1476-5462JCR Link
Citation
vol. 23, no. 3, pp. 306 - 312
Publisher
NATURE PUBLISHING GROUP
Indexed
SCI; SCIE; SCOPUS WOS scopus
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.
DOI
10.1038/gt.2015.110
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의학전문대학원 > 의학과 > Journal papers
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