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Tissue Engineered Veins in Patients With Chronic Venous Insufficiency (TECVI-1)

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ClinicalTrials.gov Identifier: NCT03784131
Recruitment Status : Not yet recruiting
First Posted : December 21, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Verigraft AB

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.

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Drug: P-TEV Phase 1

Detailed Description:

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

In this specific application a P-TEV segment 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 is a hybrid tissue consisting of the extracellular matrix (ECM) scaffold of an allogeneic vein segment derived from a cadaveric donor as well as autologous components from a sample of peripheral blood of the recipient. As the allogeneic immunogenic material from the donor has been removed and been replaced by autologous components, no immunosuppression is required.

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Experimental: Personalized Tissue Engineered Vein
P-TEV
Drug: P-TEV
Replacement of vein with failing valves with personalized tissue engineering vein containing functional valves




Primary Outcome Measures :
  1. Thrombosis leading to occlusion of the graft measured by Color Duplex Ultrasound [ Time Frame: 12 months ]
    Ultrasonographic evaluation of occlusions of the graft.

  2. Infection leading to surgical excision of the graft measured by blood samples [ Time Frame: 12 months ]
    White blood cells count: >10 x10E9/L, C- Reactive Protein (CRP): >4 mg/L, sedimentation rate: >12mm).

  3. Infection leading to surgical excision of the graft measured by Color Duplex Ultrasound [ Time Frame: 12 months ]
    Ultrasonographic examination to assess infection of the graft

  4. Infection leading to surgical excision of the graft measured by Computer Tomography [ Time Frame: 12 months ]
    Infection of the graft assessed by Computer Tomography

  5. Reporting of surgical complications [ Time Frame: 12 months ]
    Perioperative surgical complications related to the implanted graft (technical failure leading to surgical failure).


Secondary Outcome Measures :
  1. Change in symptoms assessed according to VCSS (Venous Clinical Severity Score) [ Time Frame: 12 months ]
    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).

  2. Change in symptoms assessed according to CEAP classification (clinical, etiologic, anatomic, pathophysiologic) [ Time Frame: 12 months ]
    CEAP classification is assessed on scale from C0 (No visible or palpable signs of venous disease) to C6 (Active venous ulcer).

  3. Health Related Quality of Life assessed by VEINES questionnaire [ Time Frame: 12 months ]
    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.

  4. Health Related Quality of Life assessed by EQ-5D questionnaire [ Time Frame: 12 months ]

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

    The description part contains 5 items with three 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. This index may vary between 1 and -0,594.


  5. Durability of the P-TEV assessed by Color Duplex Ultrasound [ Time Frame: 12 months ]
    The time period in which the valve contained in the implant retains its function verified by ultrasonographic examination.

  6. Vessel dilatation in the implant assessed by Duplex Color Ultrasound [ Time Frame: 12 months ]
    Ultrasonographic examination of vessel dilatation

  7. Flow abnormalities in the implant assessed by Duplex Color Ultrasound [ Time Frame: 12 months ]
    Ultrasonographic examination of flow abnormalities

  8. Wall degeneration in the implant assessed by Duplex Color Ultrasound [ Time Frame: 12 months ]
    Ultrasonographic examination of wall degeneration



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 18 and 65 years (inclusive)
  • CVI patients with 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 4)
  • Anesthesiologically cleared and meeting ASA (American Society of Anesthesiologists Classification) class 1 or 2
  • Laboratory values

    • INR <1.7 (in case the patient uses Orfarin, 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
    • Lipid profile within acceptable range according to investigator's opinion
    • Clinical chemistries (K, Ca) within acceptable range according to Investigator's opinion
  • Ability to understand the requirements of the study, provide written informed consent, and comply with the study procedures

Exclusion Criteria:

  • Patients incapable to give 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/contraception. (intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence should be used for contraception by women of childbearing period).
  • BMI ≥ 35
  • Patients who participate in other clinical trials
  • 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, Cortisol treatment etc.
  • Less than 3 months since previous ipsilateral venous intervention (e.g. Iliac recanalization)
  • Clinically significant outflow disease
  • Heavy smoker: Has smoked 20 cigarettes or more per day for at least past 5 years
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784131


Contacts
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Contact: Björquist +46705979296 ext +46705979296 info@verigraft.com
Contact: Strehl +46737260331 raimund.strehl@verigraft.com

Sponsors and Collaborators
Verigraft AB
Investigators
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Study Director: Björquist Verigraft AB

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Responsible Party: Verigraft AB
ClinicalTrials.gov Identifier: NCT03784131     History of Changes
Other Study ID Numbers: 2015-004021-13
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Verigraft AB:
CVI
Leg Ulcer
Tissue Engineering
Personalized Vascular Graft
Chronic Venous Insufficiency
ATMP
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases