TY - JOUR
T1 - Cell-based therapies for cardiac repair: A meeting report on scientific observations and European regulatory viewpoints
AU - Schüssler-Lenz, Martina
AU - Beuneu, Claire
AU - Menezes-Ferreira, Margarida
AU - Jekerle, Veronika
AU - Bartunek, Jozef
AU - Chamuleau, Steven
AU - Celis, Patrick
AU - Doevendans, Pieter
AU - O'Donovan, Maura
AU - Hill, Jonathan
AU - Hystad, Marit
AU - Jovinge, Stefan
AU - Kyselovič, J. n
AU - Lipnik-Stangelj, Metoda
AU - Maciulaitis, Romaldas
AU - Prasad, Krishna
AU - Samuel, Anthony
AU - Tenhunen, Olli
AU - Tonn, Torsten
AU - Rosano, Giuseppe
AU - Zeiher, Andreas
AU - Salmikangas, Paula
PY - 2016/2/1
Y1 - 2016/2/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84958110035&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/26470631
U2 - https://doi.org/10.1002/ejhf.422
DO - https://doi.org/10.1002/ejhf.422
M3 - Review article
C2 - 26470631
SN - 1388-9842
VL - 18
SP - 133
EP - 141
JO - European journal of heart failure
JF - European journal of heart failure
IS - 2
ER -