Allogeneic ABCB5-positive Stem Cells for Treatment of DFU "Malum Perforans"

Inclusion criteria

• ✓. Male or female patients aged 18 to 85 years;
• ✓. Patients with an existing diagnosis of diabetic mellitus Type 2, evaluated by blood test \[HbA1c\] \< 11%) at the Screening visit (Visit 1). The HbA1c value at visit 1 should not vary more than 1.5% (absolute range) compared to a HbA1c value that was previously measured 1 to 6 months before visit 1;
• ✓. The presence of diabetic neuropathic ulcers "malum perforans" (Grade I and II according to Wagner) at plantar site of the foot diagnosed by ABI ≥0.7, without claudication, or TcPO2 \>40 mmHg or doppler ultrasonography (at the discretion of the investigator) to exclude significant arterial diseases and critical limb ischemia, and a diabetic neuropathy test using a 128 Hz vibration tuning fork according to Rydel-Seiffer (as described by Guideline "Nationale Versorgungsleitlinie - Neuropathie bei Diabetes im Erwachsenenalter"). If the ABI is \>1.3, an additional doppler ultrasonography must be performed to exclude a PAOD masked by media sclerosis;
• ✓. At Screening Visit 1 and 2 the wound surface area of the target ulcer should be between 1 and 50 cm2 measured by using a scaled measuring sensor in combination with digital image analysis;
• ✓. The ulcer's surface area should be (mostly) free from callus or necrotic tissue;
• ✓. If patients are suffering from two or more ulcers at the same extremity, the target ulcer has to be separated by a minimum bridge of 1 cm of healthy tissue from other ulcers;
• ✓. Patients are willing and able to wear therapeutic shoes that are especially designed for patients with a diabetic neuropathic foot;
• ✓. Body mass index (BMI) between 20 and 45 kg/m²;

Exclusion criteria