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Docta Complutense author Gómez Cid, Lidia author Grigorian Shamagian, Lilian author Sanz Ruiz, Ricardo author Nava, Ana S. De La author Fernández, Ana I. author Fernández Santos, María Eugenia author Fernández-Avilés Díaz, Francisco Jesús 2023-06-16T14:20:05Z 2023-06-16T14:20:05Z 2021-08-31 Gómez Cid, L., Grigorian Shamagian, L., Sanz Ruiz, R. et al. «The Essential Need for a Validated Potency Assay for Cell-Based Therapies in Cardiac Regenerative and Reparative Medicine. A Practical Approach to Test Development». Stem Cell Reviews and Reports, vol. 17, n.o 6, diciembre de 2021, pp. 2235-44. DOI.org (Crossref), https://doi.org/10.1007/s12015-021-10244-5. 2629-3269 10.1007/s12015-021-10244-5 https://hdl.handle.net/20.500.14352/4722 https://doi.org/10.1007/s12015-021-10244-5 https://link.springer.com/article/10.1007/s12015-021-10244-5 Biological treatments are one of the medical breakthroughs in the twenty-first century. The initial enthusiasm pushed the field towards indiscriminatory use of cell therapy regardless of the pathophysiological particularities of underlying conditions. In the reparative and regenerative cardiovascular field, the results of the over two decades of research in cell-based therapies, although promising still could not be translated into clinical scenario. Now, when we identified possible deficiencies and try to rebuild its foundations rigorously on scientific evidence, development of potency assays for the potential therapeutic product is one of the steps which will bring our goal of clinical translation closer. Although, highly challenging, the potency tests for cell products are considered as a priority by the regulatory agencies. In this paper we describe the main characteristics and challenges for a cell therapy potency test focusing on the cardiovascular field. Moreover, we discuss different steps and types of assays that should be taken into consideration for an eventual potency test development by tying together two fundamental concepts: target disease and expected mechanism of action. eng Atribución 3.0 España The Essential Need for a Validated Potency Assay for Cell-Based Therapies in Cardiac Regenerative and Reparative Medicine. A Practical Approach to Test Development journal article URL https://docta.ucm.es/bitstreams/d4da9c4e-f6db-44fb-879c-1ccac161d1a2/download File MD5 edb20b96d73a0474720142e5ade18674 1273384 application/pdf Gómez-Cid2021_Article_TheEssentialNeedForAValidatedP.pdf URL https://docta.ucm.es/bitstreams/2cc11a3e-9a55-4307-857c-4044bd9cd86a/download File MD5 0bde2cf9fe3e62a0545d28d9340da50e 57107 text/plain Gómez-Cid2021_Article_TheEssentialNeedForAValidatedP.pdf.txt