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Study to evaluate the efficacy and safety of personalized tissue engineered veins in patients with severe chronic venous insufficiency

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Chronic Venous Insufficiency, a condition where the veins have trouble sending blood from the limbs back to the heart, often leading to swelling or skin issues. The research aims to evaluate the efficacy and safety of a Personalized Tissue Engineered Vein, referred to as P-TEV. This treatment involves the implantation of a special graft made from decellularised allogeneic vein tissue, which is biological material from a donor that has had its cells removed to prevent rejection, combined with a functional valve and the patient's own blood.

Participants in the study will receive either the P-TEV graft or a control treatment. Following the procedure, the progress of the condition and the healing of any ulcers, which are open sores on the skin, will be monitored over a period of time. The study will observe how well the new vein valves work and how much the physical symptoms and signs of the disease improve through regular check-ups using ultrasound imaging to look at blood flow.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
implantation of the personalized tissue engineered vein
An implantation procedure is performed to place a personalized tissue engineered vein. this is a biological graft made from decellularised vein tissue that includes a functional valve and is treated with blood from the body.
Step 2
follow-up monitoring at 1 month
An assessment is conducted using color duplex ultrasound, which is an imaging test used to look at blood flow, to check how well the vein valve is working.
Measurements are taken to evaluate blood flow patterns, the healing of any ulcers (open sores), and changes in physical signs like the size of the ankle and calf.
The status of symptoms, quality of life, and any side effects related to the procedure or the graft is recorded.
Step 3
follow-up monitoring at 3 months
An assessment is conducted using color duplex ultrasound to check valve function and blood flow.
Measurements are taken to evaluate ulcer healing, physical signs, symptoms, quality of life, and any side effects.
Step 4
follow-up monitoring at 6 months
An assessment is conducted using color duplex ultrasound to check valve function and blood flow.
Measurements are taken to evaluate ulcer healing, physical signs, symptoms, quality of life, and any side effects.
The valve competency, which refers to how well the valve prevents blood from flowing backward, is a primary focus of this stage.
Step 5
follow-up monitoring at 12 months
An assessment is conducted using color duplex ultrasound to check valve function and blood flow.
Measurements are taken to evaluate ulcer healing, physical signs, symptoms, quality of life, and any side effects.

Who can join the trial?

12 criteria

Both men and women can participate.
You must be between 18 and 75 years old.
You must have Chronic Venous Insufficiency, which is a condition where the veins have trouble sending blood from the limbs back to the heart.
You must have severe symptoms, such as painful swelling, changes to your skin, or leg ulcers (open sores on the leg) that keep coming back, even after receiving standard medical care.
You must have significant femoral deep venous reflux, which means the valves in the large veins in your thigh are not working correctly, allowing blood to flow backward.
Your INR, which is a blood test that measures how quickly your blood clots, must be less than 1.7.
Your platelets, which are blood cells that help with clotting, must be at a level of 100 or higher.
Your hemoglobin, a protein in red blood cells that carries oxygen, must be at a level of 100 or higher.
Your total bilirubin, a substance made during the breakdown of red blood cells, must be within a normal range.
Your ASAT and ALAT, which are enzymes tested to check how well your liver is working, must be within a specific healthy range.
Your lipid profile, which measures fats like cholesterol in your blood, must be within an acceptable range.
Your clinical chemistry, which refers to various chemical components in your blood, must be within an acceptable range.

Who cannot join the trial?

23 criteria

People who are unable to provide written informed consent, which is a signed document confirming you understand the study and agree to join.
People who are currently in other medical studies or have been in one within the last 3 months.
People with arterial pathology, which means problems with the arteries (the vessels that carry blood away from the heart), specifically if the pressure measurements in the legs are too high or too low.
People with thrombophilia, a condition that makes the blood more likely to form clots, that cannot be managed with blood-thinning medications.
People with an active infection that requires systemic antibiotic treatment, which means medicine taken throughout the whole body rather than just at one spot.
People with serious heart problems, specifically those with limited ability to perform physical activity, a left ventricular ejection fraction (LVEF) of 40% or less (a measurement of how much blood the heart pumps out with each beat), or a heart-related emergency in the last 6 months.
People with uncontrolled hypertension, which is high blood pressure that is not being kept within a healthy range.
People with renal dysfunction, meaning the kidneys are not working properly, specifically if the estimated glomerular filtration rate (eGFR) is below 45 (a measure of how well the kidneys filter waste).
People with severe hepatic impairment, which means the liver is not functioning correctly.
People currently taking medicines that weaken the immune system, such as systemic Cortisol.
People who had a procedure on the same side of the body to open a vein, such as recanalization, less than 3 months ago.
People who are unlikely to follow the study rules or participate fully.
People with iliocaval stenosis or occlusion, which means a narrowing or a complete blockage in the large veins in the abdomen.
People who had a severe case of COVID-19 that required staying in a hospital during the last 6 months.
People with an ASA classification of 4 or higher, which is a scale used by doctors to rate how sick a patient is before surgery.
People with any other uncontrolled illness that might make the study unsafe or prevent them from following the rules.
People who cannot walk or have problems moving their ankle joints.
People who have previously had an organ transplant.
People with cancer, unless it is in-situ (meaning it is still in its original place and hasn't spread) or if they have been cancer-free for at least five years.
People with autoimmune diseases, such as rheumatoid arthritis, lupus, or multiple sclerosis, where the body's immune system attacks its own healthy cells.
Women who are pregnant or breastfeeding.
People currently taking estrogen treatment.
People with a Body Mass Index (BMI) of 38 or higher, or those whose weight might make surgery or movement difficult.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Hospital De Galdakao Usansolo
Verified
Galdakao, Spain
Hospital Universitario De Jaen
Responsive
Jaen, Spain

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Investigated drugs

Personalized Tissue Engineered Vein is a specially crafted piece of vein tissue that is used to replace or repair damaged veins. It is made from donor tissue that has been treated to remove cells, leaving behind a natural structure that includes a working valve. This valve is then filled with the patient's own blood to help it function better once it is implanted into the body. The goal of this therapy is to help improve blood flow and reduce the symptoms of long-term vein problems.

ALLOGENEIC VEIN TISSUE SEGMENT, DECELLULARISED, WITH A FUNCTIONAL VALVE PERFUSED WITH AUTOLOGOUS PERIPHERAL BLOOD

What is already known about the treatment

Personalized Tissue Engineered Vein - This living tissue substitute is administered through surgical implantation to replace or repair damaged veins. It is currently an experimental therapy being studied in clinical trials to improve its use in medical practice. It is primarily used to treat chronic venous insufficiency by helping to restore proper blood flow in the veins. The treatment works by using a specially prepared donor vein segment that has been cleaned of its original cells and then infused with the patient's own blood to create a functional, living graft that mimics a natural vein.

Investigated diseases

Chronic Venous Insufficiency - This condition occurs when the veins in the legs have trouble sending blood from the limbs back to the heart. It often happens because the small valves inside the veins do not work properly. As these valves weaken or fail, blood begins to flow backward and pools in the veins. Over time, this buildup of blood increases pressure within the veins. This process can lead to visible changes in the legs and skin.