About The Project
ELR-SCAR at a Glance
ELR-SCAR is an EU-funded research project working to complete preclinical validation of a novel intervention to prevent scar tissue formation in patients who have experienced a heart attack. This intervention consists of delivering a novel elastin-like recombinant hydrogel to the heart via a minimally invasive endocardial catheter.
Joining an international and multidisciplinary team of researchers, bioengineers, clinicians, industry partners and business and regulatory experts – ELR-SCAR aims to get the technology ready for a first-in-human validation study in the next four years (2027).
The Technology
ELR-SCAR technology uses elastin-like recombinamers, which are synthetic polypeptides that mimic elastin. This novel multifunctional biomaterial offers unique properties that can help prevent cardiac remodelation, including:
- selective cell adhesion to the endocardium (forming a barrier to scar tissue formation);
- high biospecificity to the ischaemic microenvironment;
- enhanced biodegradability (allowing for safer degradation in the body);
Acting as a biocompatible scaffold to the heart, the multifunctional ELR hydrogel can support cardiac tissue regeneration, prevent scar tissue and collagen formation, and maintain elasticity.
To facilitate the delivery of the ELR hydrogel to the heart, the project will also develop a minimally invasive endocardial catheter. Both components (hydrogel + catheter) will be advanced for a first-in-human validation study for their application as a therapeutic intervention post-myocardial infarction. This study is to be conducted after the project’s completion.
In preparation for this clinical validation step, the project will also develop the needed regulatory and Intellectual Property rights strategies to ensure the clinical adoption and market access for the ELR hydrogel and catheter is addressed.
ELR-SCAR Goals and Approach
During the first year of the project, partners will optimise the ELR hydrogel’s composition and ensure favourable hemocompatibility and gelling time. At the same time, a minimally invasive, flexible and steerable catheter will be designed and developed to safely deliver the ELR hydrogel to the left ventricle of the heart in controlled amounts.
The second stage of the project will focus on preclinically validating the newly developed ELR hydrogel and catheter. This will be done through ex vivo studies using human cadavers and in vivo studies using a large animal model. The efficacy of the ELR hydrogel will be determined based on its capacity to promote cardiac functional recovery, reduce collagen formation, and improve cardiomyocyte survival in the peri-infarct.
After preclinical validation of the materials, the project will focus on upscaling and manufacturing the ELR hydrogel for commercial purposes. The goal is to produce sufficient volumes of the hydrogel that meet Good Manufacturing Practice (GMP) standards while ensuring that the production process is safe and efficient.
Project partners with expertise in regulatory affairs will focus on the regulatory and clinical development of the ELR hydrogel as a medical device. The consortium will advance a comprehensive regulatory roadmap, including contingency plans to certify the ELR hydrogel as a pharmaceutical product, allowing for preclinical drug development activities.
During this phase, the project will develop a plan for financing, clinical adoption, and market access for the ELR hydrogel and catheter. The consortium will create an intellectual property (IP) framework to protect new and existing IP. It will also conduct early-stage Health Technology Assessment (HTA) activities to assess the safety, cost-effectiveness, and ethical and legal aspects of the hydrogel.
The University of Galway, Ireland will be responsible for the coordination, management, and communication of the project. This will ensure that the project makes good progress and that project outcomes are disseminated effectively to relevant stakeholders.
