The Project

Project description
The concept of THE GRAIL project is the creation of an in vivo, in situ structured bioactive, selectively porous, bioresorbable scaffold that locally regenerates intima growth after endovascular treatment of the obstructed arteries in patients with 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 is an unexplored area of approaches of therapy for arterial obstruction by TE technology: the substitution of the diseased arterial intima (atherosclerotic plaque removed) with an absorbable bioactive scaffold, called the synthesized intimal layer (SIL), to be repopulated by resident and circulating patient resident and stem cells. 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.
The project aims to merge the single laboratories ongoing work, coordinate it and finalizing it to bring it through the whole 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
Project Acronym: THE GRAIL
Project Reference: 278557
Start Date: 2012-01-01
Duration: 60 months
Project Cost: 7.8 million euro
Contract Type: Small or medium-scale focused research project
End Date: 2016-12-31
Project Status: Execution
Project Funding: 6 million euro