Descrizione del progetto
L’elastina per ricucire un cuore spezzato
L’infarto del miocardio, o semplicemente infarto, è causato da un blocco nel flusso di sangue al cuore che può comportare danni ai tessuti. Al fine di evitare la formazione di tessuti cicatriziali, il progetto ELR-SCAR, finanziato dall’UE, propone di sviluppare un idrogel a base di elastina, una proteina che fornisce forza ed elasticità ai tessuti. Questo materiale si lega in modo efficace all’endocardio e offre una barriera contro la cicatrizzazione pur rimanendo biodegradabile. Il piano consiste nel somministrare l’idrogel al cuore dei pazienti tramite un catetere endocardico. Tale approccio verrà collaudato nel corso del progetto ELR-SCAR in un primo studio di convalida su esseri umani. Tenendo conto dell’elevata predominanza dell’infarto del miocardio tra la popolazione, si prevede che l’intervento proposto avrà un forte impatto sociale.
Obiettivo
The ELR SCAR project aims to complete preclinical validation of a novel biomaterial, an elastin-like recombinant (ELR) hydrogel, to prevent scar tissue formation in the heart following myocardial infarction (MI), commonly called a heart attack. MI is the endpoint of ischaemic heart disease (IHD). In Europe, the highest rates of IHD worldwide equal ~26.5 million patients. Standards of care interventions after MI have serious limitations in treatment efficacy (many patients are still at risk of developing heart failure) and patient safety. There is a clear medical need for new treatment solutions that prevent scar tissue formation and irreversible cardiac remodelling. Our robust preclinical dataset so far indicates that the ELR hydrogel has this promising functionality via multiple unique characteristics: it provides selective cell adhesion to the endocardium, providing a barrier to scar tissue formation; it offers high biospecificity to the ischaemic microenvironment, and it has an enhanced biodegradability, allowing for safe disintegration in the body. To facilitate endocardial delivery of the ELR hydrogel, we will develop a minimally invasive endocardial catheter in this project. Both components (hydrogel + catheter) will be advanced to the preparedness level for a first-in-human (FIH) validation study for the application as therapeutic intervention post-MI (to be performed after the project). In addition, we will develop the regulatory and IPR strategies in preparation for this clinical validation step. Considering the high societal impact of ischaemic heart disease (IHD) and MI, we will also develop a solid health economic evaluation of possible savings and patient benefits. ELR-SCAR will transform and fundamentally improve clinical practice, resulting in reducing the enormous burden that MI and its leading cause, IHD, place on society and the individual patient.
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HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinatore
H91 Galway
Irlanda