Advancing cell secretome-based therapies

Proposals should deliver results contributing to:

• Collaborative translational pipelines where researchers and biopharmaceutical developers work hand-in-hand with clinicians.

• Standardized manufacturing processes adopted by producers of innovative health technologies.

• Healthcare providers gaining access to new secretome-based therapies with demonstrated advantages over traditional treatments.

• Patients benefiting from novel therapies for conditions lacking effective therapeutic options.

• Health systems realizing improved patient outcomes and superior performance relative to current standards of care.

Proposals must cover:

• A human cell–derived secretome or defined bioactive components (extracellular vesicles, trophic factors, organelles, RNA, proteins, peptides) with a fully elucidated mechanism of action in in vitro and/or in vivo models;

• Demonstrated therapeutic activity in relevant pre-clinical disease models;

• Development of standardized analytical methods, potency assays and quality assurance workflows (including computational, organoid and organ-on-chip systems);

• A complete GMP-compliant manufacturing process, from parent cell selection, pre-conditioning and bioprocessing to secretome isolation, purification, storage, distribution, formulation and delivery;

• Definition and implementation of critical quality attributes and release criteria;

• Preparation and submission of regulatory and ethical approvals, with SOP documentation by month 12 and Investigational Medicinal Product Dossier by month 24;

• Execution of a randomized controlled clinical trial (phases 1 and 2) under all relevant regulatory requirements;

• Optional non-genetic engineering steps to enhance safety or therapeutic profile without altering the endogenous mechanism of action;

• Targeting of diseases with high prevalence or burden, with consideration of sex differences in both parent cells and therapeutic application;

• Strong SME involvement with a commitment to first deployment in the EU;

• Inclusion of clinical study details in the dedicated annex using the provided template.