Swedish personalized tissue graft company VERIGRAFT reports promising interim results from a first-in-man study in patients with deep venous insufficiency at 2023 Cell & Gene Meeting on the Mesa
One third of the patients to be included, successfully implanted with VERIGRAFT P-TEV personalized veins without need for immunosuppressants.
Gothenburg, October 2, 2023: Swedish tissue graft company VERIGRAFT has announced promising interim results from the TECVI-1 first-in-man study in patients with chronic venous insufficiency (CVI) will be presented at the 2023 Cell & Gene Meeting on the Mesa. The Company has developed a pioneering technology that uses autologous components from the recipient’s blood to ensure donor veins can be implanted without the need for immunosuppressant drugs. This overcomes one of the major obstacles to development of the sector so far.
CVI
Chronic venous insufficiency, CVI is a life-long disease occurring in various age groups and there is currently no curative treatment. Symptomatic treatment is accomplished with compression stockings and local treatment of the ulcerations. The most common causes for damage to the venous valves are deep venous thrombosis (DVT) and trauma. Affecting the deep venous system, CVI leads to painful swelling and ulceration of the lower legs. In CVI patients, the valves of the deep veins, mostly the femoral veins, do not function properly. Consequently, the faulty valves do not prevent a back-flow of the venous blood on its journey towards the heart, resulting in an increased hydrostatic pressure on the venous side in the lower leg. This gives rise to a range of symptoms including swelling, varicosities, skin changes, a throbbing sensation, pain, and ulceration on the feet, around the ankle and lower leg.
The TECVI-1 Study
The TECVI-1 study aims to evaluate the safety (incidence of adverse events including serious adverse events and clinically significant laboratory abnormalities) of personalized tissue engineered veins (P-TEV) with valves implanted in patients with severe chronic venous insufficiency (CVI). For each patient a segment of the femoral vein containing the non-functioning valve will be surgically replaced with a single P-TEV containing a functioning valve. Successful implantation and treatment should prevent the reverse flow of blood, decrease blood pooling in the lower leg, and thereby alleviate symptoms such as swelling, pain, and ulcers.
Interim results
Already five patients (out of planned 15 in the study) have undergone the procedure with no infections or surgical complications during follow-up. Although only two patients have reached the one-year endpoints so far, the results are very encouraging.
TECVI-1 Principal Investigator Dr Andrés Garcia said: “The preliminary results are promising and open up a new therapeutic opportunity for patients with severe CVI”.
VERIGRAFT CEO Petter Björquist commented: “We are presenting this news because we believe the progress so far demonstrates our key premise – that our P-TEV grafts offer a solution to the problem with transplantation of vascular grafts. It follows the recent one-year disease-free milestone reached by our first patients. We now look forward to completing TECVI-1 and advancing the other programs in our pipeline including arteries.”
For more information, please contact:
Petter Björquist, CEO VERIGRAFT
Email: petter.bjorquist@verigraft.com
About the study
The advanced therapy medicinal product (ATMP) described herein is a personalized tissue- engineered vein (P-TEV) with a functioning valve, a human vein segment graft for use in transplantation to replace a defective or missing part of a patient's vein. In this specific application a P-TEV segment with a functioning venous bicuspid valve is implanted to replace a nonfunctioning venous valve in the femoral vein of a patient suffering from severe CVI. The P-TEV is a hybrid tissue consisting of the extracellular matrix (ECM) scaffold of an allogeneic vein segment derived from a cadaveric donor as well as autologous components from a sample of peripheral blood of the recipient. As the allogeneic immunogenic material from the donor has been removed and been replaced by autologous components, no immunosuppression is required.
For further details on the study: https://clinicaltrials.gov/study/NCT03784131
About VERIGRAFT
VERIGRAFT is a biotechnology company based in Gothenburg, Sweden. The company is rooted in the Karolinska Institute, based on groundbreaking basic science with a focus on regenerative medicine since 2014.
VERIGRAFT has grown to become a forerunner in industrialized tissue engineering and advanced regenerative medicine. The company has a strategically focused R&D pipeline of personalized tissues, targeting areas such as cardiovascular and neuronal disease. VERIGRAFT will commercialize a series of personalized tissue-engineered grafts on a global market. Current and future products will help millions of patients with today uncurable diseases, severely impacting quality of life and putting numerous patients out of work or into disability programs.
VERIGRAFT ’s headquarters are located close to Gothenburg University and Sweden´s biggest university hospital in central Gothenburg. Here the company has state-of-the-art preclinical laboratories and offices. VERIGRAFT is led by a team of experienced scientists and entrepreneurs, and is backed by investors from Europe, Asia and the US. https://verigraft.com/.
