HEAL – HLA-homozygous iPSC-cardiomyocytE Aggregate manufacturing technoLogies for allogenic cell therapy to the heart

Project Acronym HEAL
Funding Program HORIZON EUROPE
Budget € 5,824,074.00
Starting-ending date 1 September 2022 – 28 February 2026

The HEAL project will focus on general bottlenecks to induced pluripotent stem cell therapies with a particular focus on heart failure, which remains a major cause of morbidity and mortality with very few treatment options. HLA-homozygous cell line derived cardiomyocyte aggregates offer the prospect of a restorative heart therapy applicable to large patient populations and to overcome economic barriers associated with autologous approaches. By developing solutions for their mass-production and cryopreservation the project activities will focus on enabling allogeneic treatment with minimum requirements for immunosuppression. Assays for assessment of immunogenicity will provide data for the development of an artificial intelligence powered algorithm to predict recipients’ immune responses for personalised design of immunosuppression protocols.

HEAL consortium

The project consortium is built on the world leading expertise of the academic, clinical and industrial partners in the fields of iPSC technology, bioprocessing, genomic engineering, analysis and safety, immunology and clinical translation.

EATRIS Role in the project

EATRIS will lead the process to investigate, compile and analyse regulatory requirements for a Clinical Trial Application (CTA), and to adapt the individual dossiers for a select country identified for a first-in-man trial based on the preclinical findings of HEAL (WP4). Furthermore, EATRIS will provide expertise in designing the best approach to the Intellectual Property (IP) landscape and cost effectiveness and will be the driving force for conducting the FTO analysis and report to partners. EATRIS will perform Health technology assessment (HTA) and initiate discussions leading to a future exploitation plan and business model (WP5).