RT Journal Article
T1 The Essential Need for a Validated Potency Assay for Cell-Based Therapies in Cardiac Regenerative and Reparative Medicine. A Practical Approach to Test Development
A1 Gómez Cid, Lidia
A1 Grigorian Shamagian, Lilian
A1 Sanz Ruiz, Ricardo
A1 Nava, Ana S. De La
A1 Fernández, Ana I.
A1 Fernández Santos, María Eugenia
A1 Fernández-Avilés Díaz, Francisco Jesús
AB 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.
PB Springer
SN 2629-3269
YR 2021
FD 2021-08-31
LK https://hdl.handle.net/20.500.14352/4722
UL https://hdl.handle.net/20.500.14352/4722
LA eng
NO 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.
NO CRUE-CSIC (Acuerdos Transformativos 2021)
NO Instituto de Salud Carlos III/Ministerio de Ciencia, Innovación y Universidades (España)
DS Docta Complutense
RD 9 may 2025