DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-2 (FGF-2) gene. The primary objective of the current Phase IIb study is to investigate the clinical efficacy of DVC1-0101 (1x10\^9 ciu/leg, 5x10\^9 ciu/leg) in patients with IC.
DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-2 (FGF-2) gene. The previous Phase I/IIa study demonstrated no serious adverse event related to the administration, and suggested possible improvement of local blood flow and walking performance of PAD patients. The primary objective of the current Phase IIb study is to investigate the clinical efficacy of DVC1-0101 (1x10\^9 ciu/leg, 5x10\^9 ciu/leg) in patients with IC. We also aim to examine the dose-response relationship using the rate of improvement in walking function as an indicator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
The investigational product will be drawn into a disposable 1 mL syringe using a 23G needle. A total of 0.5 mL of investigational product will be injected intramuscularly into each administration site. After administration, the administration sites will be wrapped with dressings.
Matsuyama Red-Cross Hospital
Matsuyama, Ehime, Japan
Kyushu University Hospital
Fukuoka, Japan
Kyushu Central Hospital
Fukuoka, Japan
Morinomiya Hospital
Osaka, Japan
Walking performance assessed by treadmill utilizing Gardner's method
Change rate from baseline in absolute claudication distance (%ACD) at 6 months Change of ACD from baseline at 6 months Change of peak walking time from baseline at 6 months Change of initial claudication distance (ICD) from baseline at 6 months Change of claudication onset time from baseline at 6 months
Time frame: 6 months
NIRS measurement
Measurement of oxygen dynamics in the leg muscles by near infrared spectroscopy after a treadmill
Time frame: Pre, day 14, 1, 2, 3, 4, 5, and 6 months
Readministration
Proportion of subjects in whom readministration was not required
Time frame: 6 months
WIQ
Evaluation of QOL based on the Walking Impairment Questionnaire (WIQ)
Time frame: Pre, 1, 3, and 6 months
Clinical stage classifications
Time-course changes using clinical stage classifications (Fontaine classification, Rutherford classification)
Time frame: Pre, day 14, 1, 2, 3, 4, 5, and 6 months
ABI/TBI
Ankle-brachial pressure index/ Toe-brachial pressure index
Time frame: Pre, day 14, 1, 3, and 6 months
VAS
visual analogue scale (VAS) and pain at rest evaluated by the frequency of analgesic use
Time frame: Pre, day 1, 2, 3, 5, 7, 14 and monthly until 6 months
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MACE
Incidence of cardiovascular events (to be followed up to 5 years after administration)
Time frame: Monthly until 1 year after gene transfer