Rome, January 2 2012
The THEGRAIL project is granted FP7 EU funds to develop bioactive and bioresorbable scaffold that locally regenerates intima growth after endovascular treatment of the obstructed arteries in patients with atherosclerosis. Within the framework of the THEGRAIL project, Explora will act as coordinator, leveraging its expertise to design and test in vivo the novel scaffold.

The concept of THE GRAIL project is the creation of an in vivo deployable bioactive scafold to treat atherosclerosis. Arterial obstruction due to arteriosclerosis is the cause of a wide spectrum of diseases, disabilities and death, because of induced ischemia in feed arteries of the diseased organs. These organs include the brain (ischemic stroke), the heart, the kidneys, the gastrointestinal tract and the lower limbs (leading to amputations, especially in diabetic patients). The purpose of the in vivo tissue engineered (TE) blood vessel is to offer an alternative treatment for patients affected with this disease: to substitute the actual mechanical, acute oriented rechanneling or by passing of obstructed arteries with a regenerative, physiological, disease solving and long term oriented, approach in the therapy of ischemic cardiovascular disease, compatible with today minimal invasive surgical techniques.

This project gathers together a multidisciplinary team including 4 research centres (University of Liverpool, Univ. of Valladolid, Institut of Bioengineering of Catalunya and the Biomaterial center of the Univ. of Naples Federico II), 1 clinical centre (University Medical Centre of Utrecht) and 3 SMEs: Explora Biotech (IT), Technical Protein Nanobiotechnology (SP) and Conic Cardiovascular (SP). In addition, Donowa Lifescience Consulting will overviews the clinical and regulatory issues to speed up the translation of the novel scaffold to the clinical setting.

"This is an unexplored area arterial obstruction therapy", says Dr. Francesco Serino (Head of the Medical biotechnology unit at Explora Biotech), "the substitution of the diseased arterial intima with an absorbable bioactive scaffold, called the synthesized intimal layer (SIL), is meant to be repopulated by resident and circulating patient's cells". Indeed, SIL does not intend to stent the artery; conversely it aims to replace the diseased and stiffened area with a soft and compliant intelligent scaffold that becomes reabsorbed once its task is completed, leaving a physiologically responsive regenerated tissue.

This project "strengthens our position in the field of bio-nanotechnology and tissue engineering”, says Dr. Davide De Lucrezia (CEO of Explora Biotech), “together with our partners we aim to go
through the entire pre-clinical process, including the whole regulatory work, the GLP animal pre-clinical implants and the design and production of TE device deployment technology”.

Project details: www.thegrail-project.eu