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Chronic Venous InsufficiencyPhase 1TECVI-1NCT03784131

Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

A Phase 1 study testing P-TEV in people with Chronic Venous Insufficiency, run by Verigraft AB at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Venous Insufficiency
What is being tested?
P-TEV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteSpain
Study dates
15 Dec 2021to 12 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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 thrombophilia according to the laboratory results at inclusion visit. One of the following criteria is needed for thrombophilia: Protein C < 40% or Protein S < 40 % or Leiden factor mutation or Antithrombin III < 40 % or present Lupus anticoagulant or Homocysteine > 1.5 ULN
  • 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)
  • Patients with moderate or severe hepatic impairment (Child Pugh ≥ 7 points, i.e. class B or C)
  • Patients with ongoing immunosuppression, systemic Cortisol treatment etc.
  • Less than 3 months since previous ipsilateral venous intervention (e.g. Iliac recanalization)
  • Clinically significant iliocaval stenosis or occlusion
  • Current smoker of more than 20 cigarettes per day
  • Other uncontrolled intercurrent illness that would jeopardize the patient's safety, interfere with the objectives of the protocol, or limit the patient's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor
  • Patients with severe SARSCoV-2 virus infection requiring hospitalization in the past 6 months

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Junta de Andalusia

    Seville

Other trials in Spain

About this study

Official title: Phase I Open-label, First-in-human Study to Evaluate Feasibility and Safety of Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

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.

Read the detailed description

The advanced therapy medicinal product (ATMP) described herein is a personalized tissue- engineered vein (P-TEV) graft for use in surgical implantation to replace a defective or missing part of a patient's vein.

In this specific application a P-TEV graft with a functioning venous bicuspid valve is implanted to replace a nonfunctioning venous valve in the femoral vein of a patient suffering from severe CVI. The P-TEV graft for surgical implantation is 4-6 cm in length.

The P-TEV drug substance consists of an extracellular matrix (ECM) scaffold in the form of a decellularized (DC) allogeneic vein scaffold which is populated with autologous components from the patient's own peripheral whole blood (PWB) in an ATMP manufacturing process performed under GMP. As the allogeneic immunogenic material has been removed from the donated vein segment by DC and as the perfusion uses autologous PWB, no immunosuppression is required.

Successful implantation and treatment should prevent the reverse blood flow, decrease blood pooling in the lower leg, and thereby alleviate symptoms such as swelling, pain, and ulcers.

Being tested
P-TEV
Keywords
CVI, Leg Ulcer, Tissue Engineering, Personalized Vascular Graft, Chronic Venous Insufficiency, ATMP
Medical subject headings
Leg Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P-TEVDrug

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

Study groups in NCT03784131
Study groupRoleWhat they receive
Personalized Tissue Engineered VeinExperimentalP-TEV
Receives: Drug: P-TEV

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Ultrasonographic evaluation of occlusions of the graft.

    Measured: 12 months

  2. 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).

    Measured: 12 months

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

    Ultrasonographic examination to assess infection of the graft

    Measured: 12 months

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

    Infection of the graft assessed by Computer Tomography

    Measured: 12 months

  5. Reporting of surgical complications

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

    Measured: 12 months

Secondary outcomes (8)

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

    The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 (absent) to 3 (severe), plus a category for compression with higher scores representing greater compliance (still scale 0-3).

    Measured: 12 months

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

    CEAP classification is assessed on scale from C0 (No visible or palpable signs of venous disease) to C6 (Active venous ulcer).

    Measured: 12 months

  3. Health Related Quality of Life assessed by VEINES questionnaire

    Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. Higher scores are associated with better quality-of-life.The focus of VEINES is on physical symptoms as opposed to psychological or social aspects.

    Measured: 12 months

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

    EQ-5D-5L is a standardized self-assessment instrument for health status.It has two components; health state description and evaluation.

    The first part contains 5 items with five levels of response regarding five dimensions (mobility, hygiene, activities, pain and anxiety).The five questions are compounded into a health index according to a mathematical formula validated against the population in several countries.The second part of the questionnaire comprises a standard vertical 20-cm VAS that is calibrated from 'the worst health you can imagine' (scored 0) at its base to 'the best health you can imagine' (scored 100) at its apex. Respondents are asked to 'mark an X on the scale to indicate how your health is TODAY' and to write the number in an adjoining box.

    Measured: 12 months

  5. Durability of the P-TEV assessed by Color Duplex Ultrasound

    The time period in which the valve contained in the implant retains its function verified by ultrasonographic examination.

    Measured: 12 months

  6. Vessel dilatation in the implant assessed by Duplex Color Ultrasound

    Ultrasonographic examination of vessel dilatation

    Measured: 12 months

  7. Flow abnormalities in the implant assessed by Duplex Color Ultrasound

    Ultrasonographic examination of flow abnormalities

    Measured: 12 months

  8. Wall degeneration in the implant assessed by Duplex Color Ultrasound

    Ultrasonographic examination of wall degeneration

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2018
  2. Study start15 Dec 2021
  3. Primary completion11 Jun 2025
  4. Study completion12 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03784131
Sponsor's protocol ID
2015-004021-13
Other IDs
2015
Acronym
TECVI-1
Status last verified
Aug 2026
First submitted
16 Nov 2018
Last updated
27 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing P-TEV in people with Chronic Venous Insufficiency, run by Verigraft AB at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thrombosis leading to occlusion of the graft measured by Color Duplex Ultrasound (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03784131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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