Arteriosclerosis obliterans
Conditions
Interventions
An AMG0001 formulation (2.5 mg/ml, 1.85 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).
A placebo, a
Sponsors
Anges MG, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who personally give informed consent in writing 2. Patients aged 40 or older but younger than 85 3. Fontaine III (resting pain) or IV (ischemic ulcer) 4. Patients in whom hemodynamic parameters meet both of the following criteria: * ABPI at rest is not more than 0.6 during the observation period. * The mean ankle pressure is less than 70 mmHg during the observation period. 5. Patients in whom revascularization in the treated limb is difficult 6. Patients in whom symptoms are not improved in the treated limbs despite the conduct of conventional medical treatment or intervention for 4 weeks or more 7. Patients who agree to contraception by a sperm passage blocking method until the end of Week 12 of treatment after giving informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with a necrotized ulcer and/or an ulcer with exposed tendon or bone 2. Patients in whom alcohol or drug dependence had been noted 90 days or less before informed consent was obtained or who had been treated for it 3. Past history of or complication with cancer 4. Patients with serious cardiac, hepatic, renal, or hematological disease 5. Patients with intercurrent hepatitis B or C, AIDS, or ATL 6. Patients who underwent revascularization or amputation (not necrotomy) 90 days or less before giving informed consent 7. Patients who underwent sympathectomy or sympathetic block 180 days or less before giving informed consent 8. Patients with an invasive infectious disease which is difficult to control with antibiotics 9. Patients with proliferating diabetic retinopathy (untreated or in the middle or late stage of proliferating retinopathy) or neovascularization-type age-related macular degeneration 10. Participation in another clinical trial 90 days or less before giving informed consent 11. Pregnant or breast-feeding women, women with suspected pregnancy, and women who desire to become pregnant during the trial 12. Past history of cell therapy 13. Past history of gene therapy 14. Blood sampling (or donation) of 200 ml or more, 30 days or less before giving informed consent, or 400 ml or more, 90 (120 in the case of women) days or less before giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of pain at rest and ischemic ulcer | — |
Secondary
| Measure | Time frame |
|---|---|
| Time course of pain at rest and Ischemic ulcer Ankle brachial index Fontaine classification Angiogenesis Incidence of subjects without analgesic Quality of life Amputation of drug-administered leg Adverse events Investigations and vital signs Serum HGF level Serum anti-HGF antibody Serum anti-Escherichia protein antibody Serum anti-DNA antibody | — |
Countries
Japan
Outcome results
None listed