Fig. 2

Milestones to accomplish in the development of MSC-based therapies for cardiac tissue regeneration. Donation of cells and tissue must be approved by competent authorities (OCATT) and the local ethics committee. Preclinical research and development focuses on studying the efficacy and safety (PoC) of the new, advanced therapy medicinal candidate in proof-of-concept studies; these studies must be in compliance with quality standards, when required (GLP). Once the PEI (equivalent to the Investigational Medicinal Product Dossier) is approved by the regulatory authorities, actual production of clinical-grade MSCs is performed in clean rooms, in accordance with GMP. Clinical testing is performed in controlled trials under GCP. Eventually, the authorization for marketing the MSC-based product is granted by the EMA; alternatively, the MSC-based product can be authorized for compassionate uses and nonindustrial production by the national competence authority (AEMPS), under the Hospital exemption clause. OCATT Organització Catalana de Transplantaments (Catalan), PoC proof-of-concept studies, GLP good laboratory practice, PEI Producto en Investigación (Spanish), GMP good manufacturing practice, GCP good clinical practice, EMA European Medicines Agency, AEMPS Agencia Española de Medicamentos y Productos Sanitarios (Spanish)