Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD

Inclusion criteria

• ✓. Male or female patients aged 45 to 85 years;
• ✓. Patients having PAOD clinically confirmed (maximal systolic ankle pressures ≤ 70 mmHg or systolic toe pressures ≤ 50 mmHg or transcutaneous partial oxygen pressures (tcp02) ≤ 30 mmHg in supine position) as Rutherford category 5 in at least one lower extremity;
• ✓. Angiography results (DSA, CTA or MRA) for the localization of the high-grade obstruction of an artery of the affected leg (≥ 70 %) that is the leading cause for the ulceration are present and not older than 3 months;
• ✓. One or more clinically relevant and quantifiable ulcer(s) below the ankle with a minimum size of 0.5 cm² per ulcer and a maximum wound size of 20 cm² for all ulcers together;
• ✓. Positive vote of the Advisory Board on the suitability of the wound(s) for enrolment, based on the wound photographs;
• ✓. Patients not eligible for surgical/interventional reconstruction due to technical limitations or comorbidity;
• ✓. No evidence of wound healing after standard of care treatment for at least 1 week before screening;
• ✓. In Patients suffering from 2 or more ulcers at the same extremity, these ulcers must be separated by a minimum bridge of 1 cm of epithelialized skin;