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

takuya matsumoto, Michiko Tanaka, Keiji Yoshiya, Ryosuke Yoshiga, Yutaka Matsubara, Kumi Horiuchi-Yoshida, Yoshikazu Yonemitsu, Yoshihiko Maehara

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish
Article number30035
JournalScientific reports
Volume6
DOIs
Publication statusPublished - Jul 15 2016

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Genetic Therapy
Ischemia
Extremities
Quality of Life
Sendai virus
Fibroblast Growth Factor 2
Health Surveys
Blood Vessels
Therapeutics
Safety
Pain
Mortality
Genes

All Science Journal Classification (ASJC) codes

  • General

Cite this

matsumoto, T., Tanaka, M., Yoshiya, K., Yoshiga, R., Matsubara, Y., Horiuchi-Yoshida, K., ... Maehara, Y. (2016). Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101. Scientific reports, 6, [30035]. https://doi.org/10.1038/srep30035

Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101. / matsumoto, takuya; Tanaka, Michiko; Yoshiya, Keiji; Yoshiga, Ryosuke; Matsubara, Yutaka; Horiuchi-Yoshida, Kumi; Yonemitsu, Yoshikazu; Maehara, Yoshihiko.

In: Scientific reports, Vol. 6, 30035, 15.07.2016.

Research output: Contribution to journalArticle

matsumoto, T, Tanaka, M, Yoshiya, K, Yoshiga, R, Matsubara, Y, Horiuchi-Yoshida, K, Yonemitsu, Y & Maehara, Y 2016, 'Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101', Scientific reports, vol. 6, 30035. https://doi.org/10.1038/srep30035
matsumoto T, Tanaka M, Yoshiya K, Yoshiga R, Matsubara Y, Horiuchi-Yoshida K et al. Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101. Scientific reports. 2016 Jul 15;6. 30035. https://doi.org/10.1038/srep30035
matsumoto, takuya ; Tanaka, Michiko ; Yoshiya, Keiji ; Yoshiga, Ryosuke ; Matsubara, Yutaka ; Horiuchi-Yoshida, Kumi ; Yonemitsu, Yoshikazu ; Maehara, Yoshihiko. / Improved quality of life in patients with no-option critical limb ischemia undergoing gene therapy with DVC1-0101. In: Scientific reports. 2016 ; Vol. 6.
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