Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

Inclusion Criteria: * Patients aged between 18 and 75 years (inclusive) * CVI patients with painful swelling and/or skin changes and/or recurrent leg ulcer despite optimal conservative treatment for a period of time according to the investigator's judgement * Patients with deep venous reflux (grade 3 and above) * Meeting ASA (American Society of Anesthesiologists Classification) class 1 or 2 according to the PIs criteria * Laboratory values * INR \<1.7 (in case the patient uses Warfarin, the test might be repeated after the anticoagulant change) * Platelets ≥ 100 x 10 9 /L * Hemoglobin ≥ 100 g/L * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) * ASAT ≤ 2.5 × ULN * ALAT ≤ 2.5 × ULN * Ability to understand the requirements of the study, give direct or representative written informed consent, and comply with the study procedures Exclusion Criteria: * Patients incapable to give direct or representative written informed consent * Patients unlikely to cooperate fully in the study and/or with an anticipated poor compliance * Non-walking patients or patients with lost ankle joint function * Patients previously organ-transplanted * Patients with cancer except in-situ stage cancer (basal-cell carcinomas and/or cervix cancer) and five year recurrence free period after treatment * Patients with autoimmune diseases including rheumatoid arthritis, SLE and MS * Pregnant or breast feeding women * Patients with ongoing estrogen treatment for example for contraception. Alt…