The TECVI project, born at the Valme University Hospital in Seville, has commenced a crucial international phase. Following favorable outcomes from the first eleven implants performed at the center, the clinical trial is expanding to Europe with the inclusion of hospitals in the Netherlands and Poland.
This pioneering research aims to change the paradigm in treating severe chronic deep vein insufficiency, a condition previously managed with palliative treatments but lacking restorative options. The strategy involves fabricating custom veins using tissue engineering to replace damaged venous segments and restore circulatory function.
The project is directed by Dr. Andrés García León, head of the Angiology and Vascular Surgery Service at the Sevillian hospital. The first phase of the trial, conducted between January 2023 and June 2025, involved eleven patients who received implants and were monitored for twelve months. Initial results showed a favorable safety profile, with no infections or direct surgical complications, and significant improvement in patients' symptoms and quality of life.
Functionally, the implant remained operational in over 80% of cases during the first month and in nearly two-thirds one year after surgery. These data have paved the way for initiating phases II and III of the trial, further evaluating the safety, efficacy, and durability in a larger patient cohort, bringing it closer to standard clinical practice.
The initiative benefits from a complex network of scientific and healthcare collaboration, including the Andalusian Network for the Design and Translation of Advanced Therapies, the Cell Production and Reprogramming Unit of Seville, and the Tissue Bank of Córdoba. The project, authorized by the Spanish Agency of Medicines and Medical Devices in December 2020, began within the Andalusian public health system and has progressively expanded, incorporating national reference centers and now European ones.
Dr. Andrés García León has received national recognition for this advancement. The presentation of the first phase's results was honored at the 71st National Congress of the Spanish Society of Angiology and Vascular Surgery in Barcelona, highlighting Andalusia's clinical and research leadership in vascular regenerative medicine.
