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Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101

Critical limb ischemia (CLI) has a poor prognosis and adversely affects patients’ quality of life (QOL). Therapeutic angiogenesis may improve mobility, mortality and QOL in CLI patients. However, the effectiveness of gene therapy on such patients’ QOL is unknown. DVC1-0101, a non-transmissible recom...

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Bibliographic Details
Published in:Scientific reports 2016-07, Vol.6 (1), p.30035-30035, Article 30035
Main Authors: Matsumoto, Takuya, Tanaka, Michiko, Yoshiya, Keiji, Yoshiga, Ryosuke, Matsubara, Yutaka, Horiuchi-Yoshida, Kumi, Yonemitsu, Yoshikazu, Maehara, Yoshihiko
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Language:English
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Summary:Critical limb ischemia (CLI) has a poor prognosis and adversely affects patients’ quality of life (QOL). Therapeutic angiogenesis may improve mobility, mortality and QOL in CLI patients. However, the effectiveness of gene therapy on such patients’ QOL is unknown. DVC1-0101, a non-transmissible recombinant Sendai virus vector expressing human fibroblast growth factor-2 gene, demonstrated safety and efficacy in a phase I/II study of CLI patients. We investigated the effects of DVC1-0101 on QOL in this cohort. QOL was assessed using the Short Form-36 health survey version 2 (SF-36) in 12 patients at pre-administration, 28 days and 3, 6 and 12 months post-treatment. We examined differences between pre and post-administration QOL scores and correlations between QOL scores and vascular parameters. Patients demonstrated low baselines scores on every SF-36 dimension. Post-treatment scores showed significant improvements in physical functioning at 3 and 6 months (P 
ISSN:2045-2322
2045-2322
DOI:10.1038/srep30035