Cell-based therapies for cardiac repair: A meeting report on scientific observations and European regulatory viewpoints

Martina Schüssler-Lenz, Claire Beuneu, Margarida Menezes-Ferreira, Veronika Jekerle, Jozef Bartunek, Steven Chamuleau, Patrick Celis, Pieter Doevendans, Maura O'Donovan, Jonathan Hill, Marit Hystad, Stefan Jovinge, Ján Kyselovič, Metoda Lipnik-Stangelj, Romaldas Maciulaitis, Krishna Prasad, Anthony Samuel, Olli Tenhunen, Torsten Tonn, Giuseppe RosanoAndreas Zeiher, Paula Salmikangas

Research output: Contribution to journalArticle

Abstract

In the past decade, novel cell-based products have been studied in patients with acute and chronic cardiac disease to assess whether these therapies are efficacious in improving heart function and preventing the development of end-stage heart failure. Cardiac indications studied include acute myocardial infarction (AMI), refractory angina, and chronic heart failure (CHF). Increased clinical activity, experience, and multiple challenges faced by developers have been recognized at the regulatory level. In May 2014, the Committee for Advanced Therapies (CAT) discussed in an expert meeting various cell-based medicinal products developed for cardiac repair, with a focus on non-manipulated bone marrow cells, sorted bone marrow or apheresis, and expanded cells, applied to patients with AMI or CHF. The intention was to share information, both scientific and regulatory, and to examine the challenges and opportunities in this field. These aspects were considered from the quality, and non-clinical and clinical perspectives, including current imaging techniques, with a focus on AMI and CHF. The scope of this overview is to present the European regulatory viewpoint on cell-based therapies for cardiac repair in the context of scientific observations.

Original languageEnglish
Pages (from-to)133-141
Number of pages9
JournalEuropean Journal of Heart Failure
Volume18
Issue number2
DOIs
Publication statusPublished - Feb 1 2016

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Keywords

  • Advanced therapy medicinal products
  • Cell-based therapies for cardiac repair
  • Committee for Advanced Therapies
  • European regulatory aspects

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Schüssler-Lenz, M., Beuneu, C., Menezes-Ferreira, M., Jekerle, V., Bartunek, J., Chamuleau, S., Celis, P., Doevendans, P., O'Donovan, M., Hill, J., Hystad, M., Jovinge, S., Kyselovič, J., Lipnik-Stangelj, M., Maciulaitis, R., Prasad, K., Samuel, A., Tenhunen, O., Tonn, T., ... Salmikangas, P. (2016). Cell-based therapies for cardiac repair: A meeting report on scientific observations and European regulatory viewpoints. European Journal of Heart Failure, 18(2), 133-141. https://doi.org/10.1002/ejhf.422