In short
Clinical trials are investigating ALLOGENEIC VEIN TISSUE SEGMENT, DECELLULARISED, WITH A FUNCTIONAL VALVE PERFUSED WITH AUTOLOGOUS PERIPHERAL BLOOD in patients with chronic venous insufficiency. The studies aim to assess safety and efficacy, especially whether the treatment can improve valve function and reduce symptoms in people with severe disease.
Key points
- Clinical trials are studying ALLOGENEIC VEIN TISSUE SEGMENT, DECELLULARISED, WITH A FUNCTIONAL VALVE PERFUSED WITH AUTOLOGOUS PERIPHERAL BLOOD in people with chronic venous insufficiency. The main trial is an interventional, randomized, open-label study in severe cases. It is listed as Phase 4 and includes 60 participants. Researchers are measuring valve competency and symptom improvement at 6 months after implantation. The study also looks at whether the treatment can reduce deep venous valve problems and improve clinical signs of the disease.
Trial overview
The clinical trial in the source data is an interventional study of ALLOGENEIC VEIN TISSUE SEGMENT, DECELLULARISED, WITH A FUNCTIONAL VALVE PERFUSED WITH AUTOLOGOUS PERIPHERAL BLOOD in patients with chronic venous insufficiency. The trial is authorised and includes 60 participants.
The study title describes it as a Phase II/III randomized controlled open-label trial, while the phase field lists Phase 4. This means the research is comparing treatment groups in a planned way and is focused on how well the treatment works and how safe it is in real patients.
Who is being studied
The target population is people with chronic venous insufficiency, especially those with severe CVI. The brief summary says the study is intended to show benefit in patients with severe disease, including effects on deep venous valve problems and on symptoms.
Chronic venous insufficiency is a long-term vein problem in which blood does not return to the heart properly. In this trial, the focus is on patients whose vein valves are not working well enough and who may have ongoing clinical signs and symptoms.
Study design and phase
This is an interventional study, which means participants receive the study treatment and the results are measured afterward. It is also described as randomized controlled, meaning participants are assigned to groups by chance so the treatment can be compared with control care.
The study is open-label, so the treatment assignment is not hidden from participants or researchers. The intervention listed is a drug named Personalized Tissue Engineered Vein, given as implantation.
What the trial measures
The main outcome is valve competency at 6 months after implantation compared with control, measured using Color Duplex Ultrasound to check for reflux. Valve competency means how well the valve closes and prevents blood from flowing backward.
The second main outcome is rVCSS score reduction at 6 months after implantation compared with control. The rVCSS is a score used to track clinical signs and symptoms of chronic venous insufficiency, so a drop in the score suggests improvement.
The study summary also says the researchers want to show disease-modifying efficacy and clinical efficacy. In simple terms, this means they want to see whether the treatment can change the course of the vein disease itself and also improve how patients feel and function.
What the study seeks to show
The first goal is to reduce deep venous valve pathology in patients with severe chronic venous insufficiency. Deep venous valve pathology means damage or disease in the valves inside deep veins, which can lead to backward blood flow.
The second goal is to reduce the clinical signs and symptoms of chronic venous insufficiency. This makes the trial important for understanding whether the treatment can help both the vein function and the patient’s day-to-day disease burden.