title: Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101.
abstract: 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 < 0.05), role-physical at 3, 6, and 12 months (P < 0.05), bodily pain at 1, 3, 6, and 12 months (P < 0.05), vitality at 1, 6, and 12 months (P < 0.05), and physical component summary at 6 and 12 months (P < 0.05). DVC1-0101-based gene therapy may improve QOL in CLI patients over a 6-month period.
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Takuya
authors.initials: T
authors.lastname: Matsumoto
authors.affiliation: R&D Laboratory for Innovative Biotherapeutics Science, Graduate School of Pharmaceutical Sciences, Kyushu University, Rm. 601, Collaborative Research Station I, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Michiko
authors.initials: M
authors.lastname: Tanaka
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Yoshiya
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Ryosuke
authors.initials: R
authors.lastname: Yoshiga
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Matsubara
authors.affiliation: R&D Laboratory for Innovative Biotherapeutics Science, Graduate School of Pharmaceutical Sciences, Kyushu University, Rm. 601, Collaborative Research Station I, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Kumi
authors.initials: K
authors.lastname: Horiuchi-Yoshida
authors.affiliation: R&D Laboratory for Innovative Biotherapeutics Science, Graduate School of Pharmaceutical Sciences, Kyushu University, Rm. 601, Collaborative Research Station I, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Yonemitsu
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000235:genetics* / Q000378:metabolism; D015316:Genetic Therapy / Q000379:methods*; D006801:Humans; D007511:Ischemia / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D035002:Lower Extremity / Q000098:blood supply* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D018919:Neovascularization, Physiologic / Q000502:physiology*; D010146:Pain; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D016222:Fibroblast Growth Factor 2