Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)

Inclusion Criteria:

1. Male or female patients at least 18 years old;

2. Chronic venous leg ulcer (as defined by the current AWMF guidelines:therapy-resistant ulcer that shows no tendency to heal within 3 months despite ofoptimal phlebological therapies or has not fully healed within 12 months) at lowerleg and/or ankle region and has not been present longer than 15 years, diagnosed bydoppler or duplex sonography, ankle brachial index (ABI, 0.9-1.3), physicalexamination and dermatological review;

3. Wound size of target ulcer between 1 and 50 cm² measured by a standardizedphotography at the screening visit;

4. If patients have 2 or more ulcers at the same extremity, the target ulcer has to beseparated by a minimum bridge of 1 cm of epithelialized skin from other ulcers (thelargest ulcer should be the target ulcer, if not decided otherwise at discretion ofthe investigator; the target ulcer is defined at Visit 1);

5. Body mass index between 15 and 50 kg/m²;

6. Patients understand the nature of the procedure and are providing written informedconsent prior to any clinical trial procedure;

7. Women of childbearing potential must have a negative blood pregnancy test at Visit 1;

8. Women of childbearing potential and their partner must be willing to use highlyeffective contraceptive methods during the course of the clinical trial.

Exclusion Criteria:

1. Evidence of the ulcer extending to the underlying muscle, tendon, or bone;

2. Diabetes mellitus that has to be confirmed by blood test (Hemoglobin A1c >7.5%);

3. Peripheral Artery Disease including claudication with need of treatment;

4. Acute deep vein thrombosis (maximum 30 days from diagnosis) or a still untreateddeep vein thrombosis;

5. Unable to tolerate leg ulcer compression bandage;

6. Infection of the target ulcer requiring treatment as judged clinically;

7. All diagnosed disorders, unrelated to CVU, that are influencing wound healing of thetarget wound at investigator's discretion;

8. Current use of medications that influence wound healing: systemicimmunosuppressives, cytotoxic medicinal products, and systemic steroids (aboveCushing-threshold level);

9. Patient who, in the opinion of the investigator, for any reason are unable orunwilling to complete the trial per protocol (e.g. alcohol or substance abuse, notmobile, short life expectancy) or there is evidence of any other medical condition (such as psychiatric illness, physical examination, or laboratory findings) that mayinterfere with the planned treatment, affect the patient's compliance, or place thepatient at high risk of complications related to the treatment;

10. Any malignancy within the past 5 years, excluding successfully treated carcinoma insitu, basal cell carcinoma or squamous cell carcinoma of the skin without evidenceof metastases;

11. Pregnant or lactating women;

12. Any known allergies to components of the IMP;

13. Prior surgical procedures such as bypass or mesh-graft treatment at target legwithin 2 months prior to Visit 1 at target leg;

14. Patients with significant ulcer healing or wound size enlargement of more than 25%at Visit 2 compared to Visit 1;

15. Treatment of target ulcer with active wound care agents (e.g. Iruxol®N), which havenot been paused 14 days before IMP application;

16. Current or previous (within 30 days of enrollment) treatment with another IMP, orparticipation and/or under follow-up in another clinical trial;

17. Previous participation in this clinical trial (except for screening failures due toan inclusion or exclusion criterion);

18. Employees of the sponsor, or employees or relatives of the investigator.