Personalized tissue engineered veins for chronic venous insufficiency
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 is testing a new type of personalized vein made from the patient's own cells to see if it can safely help people with severe chronic venous insufficiency feel better and reduce symptoms like swelling and leg ulcers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Verigraft AB Industry-sponsored |
| Locations | 1 site (Sevilla) |
| Trial ID | NCT03784131 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of personalized tissue engineered veins (P-TEV) with valves in patients suffering from severe chronic venous insufficiency (CVI). The approach involves surgically replacing a segment of the femoral vein with a P-TEV graft that contains a functioning valve, aimed at preventing reverse blood flow and alleviating symptoms such as swelling and leg ulcers. The P-TEV is created using a decellularized vein scaffold populated with the patient's own blood components, eliminating the need for immunosuppression. The study will monitor adverse events and laboratory abnormalities to assess the safety of this innovative treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with severe CVI who have not responded to optimal conservative treatment and have deep venous reflux.
Not a fit: Patients who are unable to provide informed consent or are unlikely to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with chronic venous insufficiency by alleviating symptoms and preventing complications.
How similar studies have performed: While this approach is innovative, similar studies in tissue engineering have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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
Where this trial is running
Sevilla
- Junta de Andalusia — Sevilla, Spain (Recruiting)
Study contacts
- Study coordinator: Björquist
- Email: info@verigraft.com
- Phone: +46705979296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.