Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

NCT03784131 | Completed Phase 1

• 2 other identifiers: 2015-004021-132015
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety (incidence of adverse events including serious adverse events and clinical significant laboratory abnormalities) of personalized tissue engineered veins (P-TEV) with valves implanted in patients with severe chronic venous insufficiency (CVI). For each patient a segment of the femoral vein containing the non-functioning valve will be surgically replaced with a single P-TEV containing a functioning valve.

Conditions

Chronic Venous Insufficiency

Keywords

CVI; Leg Ulcer; Tissue Engineering; Personalized Vascular Graft; Chronic Venous Insufficiency; ATMP

Outcome Measures

Primary Outcomes (5)

• Thrombosis leading to occlusion of the graft measured by Color Duplex Ultrasound

  Ultrasonographic evaluation of occlusions of the graft.

  12 months

• Infection leading to surgical excision of the graft measured by blood samples

  White blood cells count: \>10 x10E9/L, C- Reactive Protein (CRP): \>4 mg/L, sedimentation rate: \>12mm).

  12 months

• Infection leading to surgical excision of the graft measured by Color Duplex Ultrasound

  Ultrasonographic examination to assess infection of the graft

  12 months

• Infection leading to surgical excision of the graft measured by Computer Tomography

  Infection of the graft assessed by Computer Tomography

  12 months

• Reporting of surgical complications

  Perioperative surgical complications related to the implanted graft (technical failure leading to surgical failure).

  12 months

Secondary Outcomes (8)

• Change in symptoms assessed according to VCSS (Venous Clinical Severity Score)

  12 months

• Change in symptoms assessed according to CEAP classification (clinical, etiologic, anatomic, pathophysiologic)

  12 months

• Health Related Quality of Life assessed by VEINES questionnaire

  12 months

• Health Related Quality of Life assessed by EQ-5D-5L questionnaire

  12 months

• Durability of the P-TEV assessed by Color Duplex Ultrasound

  12 months

Study Arms (1)

Personalized Tissue Engineered Vein

EXPERIMENTAL

P-TEV

Drug: P-TEV

Interventions

P-TEV DRUG

Replacement of vein with failing valves with personalized tissue engineering vein containing functional valves

Personalized Tissue Engineered Vein

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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. Alternative contraceptive methods (e.g. intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence) should be used by women of reproductive age (defined as pre-menopausal female capable of becoming pregnant).
• BMI ≥ 35
• Patients who have participated in other clinical trials during the last 12 months
• Patients with artery pathology (ankle-brachial pressure index \< 0,9 or \> 1,3)
• Patients with an active infection requiring systemic antibiotic treatment
• Patients with clinically significant cardiac disease (New York Heart Association, Class III or IV) or measured LVEF 40%
• Patients with uncontrolled hypertension
• Patients with renal dysfunction eGFR \< 45 ml/min (according to the MDRD calculation)

Sponsors & Collaborators

• Verigraft AB: lead

Study Sites (1)

Junta de Andalusia

Seville, Spain

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Björquist

  Verigraft AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: December 21, 2018
• Study Start: December 15, 2021
• Primary Completion: June 11, 2025
• Study Completion: June 12, 2025
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

ES (1)