Document Detail


DVC1-0101 to treat peripheral arterial disease: a Phase I/IIa open-label dose-escalation clinical trial.
MedLine Citation:
PMID:  23319060     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
We here report the results of a Phase I/IIa open-label four dose-escalation clinical study assessing the safety, tolerability, and possible therapeutic efficacy of a single intramuscular administration of DVC1-0101, a new gene transfer vector based on a nontransmissible recombinant Sendai virus (rSeV) expressing the human fibroblast growth factor-2 (FGF-2) gene (rSeV/dF-hFGF2), in patients with peripheral arterial disease (PAD). Gene transfer was done in 12 limbs of 12 patients with rest pain, and three of them had ischemic ulcer(s). No cardiovascular or other serious adverse events (SAEs) caused by gene transfer were detected in the patients over a 6-month follow-up. No infectious viral particles, as assessed by hemagglutination activity, were detected in any patient during the study. No representative elevation of proinflammatory cytokines or plasma FGF-2 was seen. Significant and continuous improvements in Rutherford category, absolute claudication distance (ACD), and rest pain were observed (P < 0.05 to 0.01). To the best of our knowledge, this is the first clinical trial of the use of a gene transfer vector based on rSeV. The single intramuscular administration of DVC1-0101 to PAD patients was safe and well tolerated, and resulted in significant improvements of limb function. Larger pivotal studies are warranted as a next step.
Authors:
Yoshikazu Yonemitsu; Takuya Matsumoto; Hiroyuki Itoh; Jin Okazaki; Makiko Uchiyama; Kumi Yoshida; Mitsuho Onimaru; Toshihiro Onohara; Hiroyuki Inoguchi; Ryoichi Kyuragi; Mototsugu Shimokawa; Hiroshi Ban; Michiko Tanaka; Makoto Inoue; Tsugumine Shu; Mamoru Hasegawa; Yoichi Nakanishi; Yoshihiko Maehara
Publication Detail:
Type:  Case Reports; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article     Date:  2013-01-15
Journal Detail:
Title:  Molecular therapy : the journal of the American Society of Gene Therapy     Volume:  21     ISSN:  1525-0024     ISO Abbreviation:  Mol. Ther.     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-03-01     Completed Date:  2013-10-22     Revised Date:  2014-03-06    
Medline Journal Info:
Nlm Unique ID:  100890581     Medline TA:  Mol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  707-14     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Cytokines / metabolism
Female
Fibroblast Growth Factor 2 / genetics*
Gene Transfer Techniques
Genetic Therapy / methods*
Genetic Vectors
Humans
Injections, Intramuscular
Male
Middle Aged
Peripheral Arterial Disease / genetics,  therapy*
Sendai virus / genetics
Treatment Outcome
Chemical
Reg. No./Substance:
0/Cytokines; 103107-01-3/Fibroblast Growth Factor 2
Comments/Corrections

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