A Germani

A Tiong

AD Culverwell

E Hernandez-Osma

F Sedighiani

H Shigematsu

I Baumgartner

I Masaki

LA Killewich

M Onimaru

M Presta

MG Davies

MS Amer

NA Mughal

R Madonna

RJ Lederman

RW Sprengers

S Fukuhara

S Rajagopalan

S Takeshita

V Aboyans

Y Suzukamo

Y Yonemitsu

Scientific Reports

AbstractCritical 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 &lt; 0.05), role-physical at 3, 6 and 12 months (P &lt; 0.05), bodily pain at 1, 3, 6 and 12 months (P &lt; 0.05), vitality at 1, 6 and 12 months (P &lt; 0.05) and physical component summary at 6 and 12 months (P &lt; 0.05). DVC1-0101-based gene therapy may improve QOL in CLI patients over a 6-month period.</jats:p

Takuya Matsumoto

Michiko Tanaka

Keiji Yoshiya

Ryosuke Yoshiga

Yutaka Matsubara

Kumi Horiuchi-Yoshida

Yoshikazu Yonemitsu

Yoshihiko Maehara

Crossref

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

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

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