Antimicrobial Agents and Chemotherapy

Biography

Biography: Luis Rodríguez-Borlado

Abstract

Advanced therapy medicinal products are new medical products based on genes, cells or tissues. These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as ischemic heart disease, Alzheimer's, cancer or immune-deficiencies. They have huge potential for patients and industry but they also present challenges that need to be properly addressed to be able to translate these therapies to the clinic. Marketing authorization of ATMPs requires, as for all medicinal products, that the applicant demonstrates that the product is consistently manufactured to a predefined quality, and that it is safe and efficacious in patients. Moreover, the use of a live material incorporates new challenges to the process related with bioequivalence between different cellular batches and the development of potency assays. After an AMI, the loss of contractile tissue drives to a degenerative process and finally to a chronic heart failure. There are no efficient therapies besides the organ transplantation and the scarcity of donors, the cost of the treatment and the side effects associated have limited the application of this therapy. Cell therapy has rose as an alternative for the treatment of this pathology but to be clinical effective it needs to be affordable, to produce a robust regenerative response and to be reproducible and equivalent between the different GMP produced batches. Coretherapix has initiated a clinical trial using allogeneic cardiac stem cells for the treatment of the acute myocardial infarction.