A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers

Major Inclusion Criteria:

• Written informed consent for participation in the study

• Male or female patient aged ≥18 years

• BMI ≥18.5 and ≥40.0 kg/m2

• Lower leg wound due to venous insufficiency

• Target wound has failed to heal despite standard wound care for a minimum of 6 weeks

• A surface area of the target wound of ≥2 and ≤40 cm2

Major Exclusion Criteria:

• Signs or symptoms of clinically significant ongoing infection i the target woundrequiring anti-microbial treatment

• History of autoimmune disease, such as but not limited to systemic lupuserythematosus, Addison's disease, Crohn's disease and type I diabetes mellitus

• B-HbA1C value ≥52 mmol/mol

• Plaque psoriasis or any other skin disease that could interfere with the outcome ofthe study

• Arterial insufficiency

• History of any malignancy within the past 5 years

• Target wound diagnosed as a malignant wound, neuropathic wound, pressure wound orosteomyelitis

• Patients who are immunocompromised due to disease or for other reasons such as theuse of systemic immunosuppressants