peripheral artery disease
Conditions
Sponsors
Ixaka Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 to
Exclusion criteria
Exclusion criteria: 1. Advanced CLTI defined as presence of major tissue loss (i.e significant ulceration and/or gangrene) proximal to the metatarsal heads (CLTI Rutherford Category 6). Significant ulceration/gangrene means any ulceration that extends beyond the subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the metatarsal heads. 2. CLTI Rutherford Category 4. 3. Uncontrolled or untreated proliferative retinopathy. 4. Failed surgical or endovascular revascularization on the index leg within 10 days prior to screening. 5. Subjects in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory or non-atherosclerotic disorder (e.g., thromboangiitis obliterans (Buerger*s Disease), or systemic sclerosis (both limited and diffuse forms). 6. Clinical evidence of invasive infection on index leg defined as major tissue loss at the mid-foot or heel involving tendon and/or bone, and/or when according to the Investigator intravenous antibiotics are required to treat the infection. 7. At screening, the presence of only neuropathic ulcers on the index leg. 8. Amputation at or above the talus on the index leg. 9. Planned major amputation within the first month after randomization. 10. Subjects who may not be healthy enough to successfully complete all protocol requirements including BM collection, or who are not expected to survive more than 12 months, or in whom results may be particularly difficult to assess, as assessed by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Rutherford classification from CLTI Category 5 to Category 4 or lower 12 months after administration of REX-001 or placebo. Success is defined as complete healing of all ischemic ulcers on the index leg. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints at 12 months after administration of REX-001 or placebo are defined: • Change in Rutherford classification from CLI Category 5 to Category 3 or lower. • Change from Baseline to Visit 9 (12 months) in TcpO2 • Partial healing of ischemic ulcers ((>= 50% reduction in size as compared to ulcer size at baseline). • AFS. | — |
Countries
Netherlands
Outcome results
None listed