Arteriosclerosis Obliterans (ASO) Buerger'
Conditions
Interventions
An AMG0001 formulation (2.5 mg/ml, 2.1 ml/vial) will be prepared before use and administered to 8 sites with ischemia in the target limb, 0.5 mg of AMG0001 per site (total dose: 4.0 mg).
Sponsors
Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who personally give informed consent in writing (2) Patients aged 20 or older but younger than 85 (3) Patients who have a stenosis or occlusion in superficial femoral artery, popliteal artery, or artery below the popliteal of the treated limb confirmed by MRA or CTA. (4) The mean ankle pressure is less than 70 mmHg or ABI is not more than 0.6 during the observation period. (However, this shall not apply in the case of Buerger's disease.) (5) Those who have the following clinical symptoms due to stenosis or occlusion. ? Rest pain(Fontaine III) VAS is at least 20 mm during the observation period ? Ulcer(Fontaine IV) (6) Patients in whom revascularization in the treated limb is difficult, or patients who are determined that the adaptation is not impossible but there are some risks in surgery (7) Patients showing no symptom of improvement in the treated limb despite the conduct of conventional medical treatment or intervention for more than two weeks in the observation period after obtaining informed consent. The conventional medical treatment or intervention needs to be continued more than two weeks before obtaining the informed consent. (8) Patients who agree to contraception by a sperm passage blocking method until the end of Week 12 of treatment after obtaining informed consent (9) Inpatient, outpatient allowed
Exclusion criteria
Exclusion criteria: (1) Patients with a necrotized ulcer and/or an ulcer with exposed tendon or bone in the treated or non-treated limb (2) Patients in whom alcohol or drug dependence had been noted 90 days or less before obtaining informed consent (3) Patient with malignant tumor history or merger. Patients with no recurrence of breast cancer more than 10 years, and with no recurrence of all other tumor types before obtaining informed consent, may be enrolled in the clinical research. Patients must been completed the cancer screening tests as defined in the protocol. (4) Patient with serious cardiac, renal or hematological disease, but excluding plateau chronic maintenance dialysis patients. (5) Patients with HIV antigen or antibody positive (6) Patients who underwent revascularization or amputation in the treated or non-treated limb, excluding small incision, necrotomy or onychectomy etc. (7) Patients who underwent sympathectomy or sympathetic block 90 days or less before obtaining informed consent (8) Patients with an invasive infectious disease which is difficult to control with antibiotics (9) Patients with proliferative diabetic retinopathy of untreated or treatment-resistant, or patients with neovascularization-type age-related macular degeneration (10) Patients with diabetic neuropathy (diffuse symmetrical neuropathy) (11) Participation in another clinical trial 30 days or less before obtaining informed consent (12) Past history of gene therapy excluding AMG0001 (13) Pregnant or breast-feeding women, women with suspected pregnancy, and women who desire to become pregnant during the clinical research (14) Patients who were judged to be unsuitable for the clinical research by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of pain at rest and ischemic ulcer | — |
Countries
Japan
Contacts
Public ContactMunehisa Shimamura
Osaka University Graduate School of Medicine Department of Health Development and Medicine
Outcome results
None listed