Last November, the team from the Angiology and Vascular Surgery Service at Bellvitge University Hospital (HUB) performed Catalonia's first implantation of a valved vein segment for the treatment of chronic venous insufficiency.
The project, led by Dr Antoni Romera, clinical head of the Service, is part of the TECVI-1 clinical trial. This study is sponsored by the Swedish company VERIGRAFT Iberia and coordinated by the Andalusian Network for the Design and Translation of Advanced Therapies (RAdytTA) of the Progress and Health Foundation of the Andalusian Ministry of Health and Consumer Affairs. RAdytTA is responsible for the manufacturing, coordination, and management of the trial. Additionally, the Autonomous Transplant Coordination of Andalusia and the Tissue Bank of Cordoba are collaborating on this initiative.
It is a pioneering worldwide multicenter study aimed at enhancing the quality of life for patients suffering from secondary venous insufficiency due to malfunctioning valves within the deep venous system. The uniqueness of this project lies in the production of a personalised venous implant (P-TEV, Personalized Tissue-Engineered Vein), which constitutes a fully biological advanced therapy drug tailored to each individual patient.
A cadaveric donor vein segment containing a functional valve is used, from which the cellular component is removed and replaced with cells from the recipient using a tissue engineering process from the patient's blood.
Days prior to the surgery, blood was drawn from the recipient patient, and the vein was prepared and biologically adapted. On the scheduled day for the surgery, the personalised venous segment was received, and doctors Antoni Romera and Emma Espinar conducted the implantation procedure on the patient. The surgery involves an inguinal incision, during which the diseased vein is identified and replaced with the prepared vein containing a properly functioning valve.
Since last November, the patient's progress has been positive, showing a significant improvement in symptoms. Dr Elena Iborra, head of the Service of Angiology and Vascular Surgery at Bellvitge Hospital, emphasizes that this innovative tissue engineering procedure "represents an alternative that could potentially transform the lives of individuals suffering from specific femoral vein pathologies, for which treatment options were previously limited." To date, fifteen surgeries have been conducted across Spain to facilitate such implants, aimed at addressing chronic venous insufficiency.
Chronic venous insufficiency stems from a malfunction of the valves in the major veins of the legs, hindering proper blood circulation. The impaired valve inhibits the smooth flow of blood, resulting in a persistent condition characterised by symptoms such as leg heaviness, swelling, and the development of ulcers.