The Essential Need for a Validated Potency Assay for Cell-Based Therapies in Cardiac Regenerative and Reparative Medicine. A Practical Approach to Test Development Articles uri icon

authors

  • GOMEZ CID, LIDIA
  • GRIGORIAN-SHAMAGIAN, LILIAN
  • SANZ RUIZ, RICARDO
  • DE LA NAVA, ANA S.
  • FERNANDEZ, ANA I.
  • FERNÁNDEZ SANTOS, MARÍA EUGENIA
  • FERNÁNDEZ AVILÉS, FRANCISCO

publication date

  • August 2021

start page

  • 2235

end page

  • 2244

issue

  • 6

volume

  • 17

International Standard Serial Number (ISSN)

  • 1550-8943

abstract

  • 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.

subjects

  • Biology and Biomedicine

keywords

  • cell therapy; potency test; mechanism of action; cardiac regenerative and reparative medicine