Severe Intermittent Claudication (IC) Secondary to Peripheral Artery Disease
Conditions
Interventions
Placebo (0 ciu/limb), single intramuscular injection
DVC1-0101 low dose (1x10^9 ciu/limb), single intramuscular injection
DVC1-0101 high dose (5x10^9 ciu/limb), single intramuscular injection
Sponsors
Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Meet criteria (1) to (5) below and are confirmed as such by at least 1 specialist qualified by the Japanese Society for Cardiovascular Surgery and at least 1 physician with deep experience Cardiovascular Intervention. (1) arteriosclerosis obliterans with stable symptoms, have intermittent claudication (ACD < 200 m) and are able to walk on a treadmill (2) resting ABI < 0.9 (3) refuse revascularization, risk of revascularization may be greater than the benefit, or develop obliteration after revascularization (4) angiographic findings show patency from the abdominal aorta through to the proximal side of the external iliac artery (5) angiographic findings meet the above criterion (4), and have stenosis or obliteration under the femoropopliteal region with morphology defined as type C or D based on TASCII 2) Administering cilostazol for at least 1 month and meet criterion 1). 3) Aged 30 and over. 4) Either sex, either inpatients or outpatients. 5) Able to give written consent for themselves.
Exclusion criteria
Exclusion criteria: 1) Have ischemic ulcer. 2) Diagnosed with Buerger's disease. 3) Have a current or past history of life-threatening allergies. 4) Have been shown or are suspected to have cancer. 5) With concurrent proliferative intraocular neovascularization. 6) With poorly controlled diabetes mellitus. 7) With concurrent cardiac failure. 8) With untreated severe arrhythmia. 9) Have or are suspected to have interstitial pneumonia. 10) Have progressive hepatic disorders. 11) Have moderate or severe hepatic disorders. (1) AST or ALT >2.5 times the upper limit (2) Prothrombin time is 14 seconds or longer (3) Serum bilirubin >2.0 times the upper limit 12) Diagnosed with hepatic cirrhosis (classified as B or C on the Child-Pugh). 13) Have an inflammatory disease. 14) Treated with immunosuppressants or corticosteroids for the treatment of various inflammatory diseases or after organ transplantation. 15) Underwent extirpative surgery of a malignant tumor in the past 5 years. 16) Have had a cerebral hemorrhage or cerebral infarction in the past 6 months. 17) With blood diseases. 18) With moderate or severe renal dysfunction (CCr <40 mL/min) 19) With alcohol or drug dependence. 20) Pregnant/lactating female, or who wish or are suspected to be pregnant. 21) Positive HIV antibodies. 22) Took part in any other clinical studies or research in the past 30 days. 23) Have allergic to the antibiotics and/or the Ribavirin. 24) Not permitted to participate in this study by the principal investigator or sub-investigator for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: at 6 months after gene transfer - Rate of increase in absolute claudication distance (ACD) - ACD - Peak walking time - Initial claudication distance (ICD) - Claudication onset time | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: at 6 months after gene transfer - Measurement of oxygen dynamics in the leg muscles by near infrared spectroscopy after a treadmill load test - Proportion of subjects in whom readministration was not required - Evaluation of QOL based on the Walking Impairment Questionnaire (WIQ) - Time-course changes using clinical stage classifications (Fontaine classification, Rutherford classification) - Ankle-brachial pressure index - Toe-brachial pressure index - Time-course changes in pain at rest evaluated by the visual analogue scale - Time-course changes in pain at rest evaluated by the frequency of analgesic use - Incidence of cardiovascular events (to be followed up to 5 years after administration) | — |
Countries
Japan
Contacts
Public ContactYoshikazu Yonemitsu MD PhD FAHA
Kyushu University R&D Laboratory for Innovative Biotherapeutics, Graduate School of Pharmaceutical Sciences
Outcome results
None listed