TY - JOUR
T1 - Moving beyond surrogate endpoints in cell therapy trials for heart disease
AU - Malliaras, Konstantinos
AU - Marbán, Eduardo
PY - 2014
Y1 - 2014
N2 - Cell therapy for heart disease began clinically more than a decade ago. Since then, numerous trials have been performed, but the studies have been underpowered, focusing primarily on low-risk patients with a recent myocardial infarction. Many data have accumulated on surrogate endpoints such as ejection fraction, but few clinical conclusions can be drawn from such studies. We argue here that the time is right for targeting larger and/or higher-risk populations for whom there is some expectation of being able to influence mortality or rehospitalization.
AB - Cell therapy for heart disease began clinically more than a decade ago. Since then, numerous trials have been performed, but the studies have been underpowered, focusing primarily on low-risk patients with a recent myocardial infarction. Many data have accumulated on surrogate endpoints such as ejection fraction, but few clinical conclusions can be drawn from such studies. We argue here that the time is right for targeting larger and/or higher-risk populations for whom there is some expectation of being able to influence mortality or rehospitalization.
UR - http://www.scopus.com/inward/record.url?scp=84892762560&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84892762560&partnerID=8YFLogxK
U2 - 10.5966/sctm.2013-0104
DO - 10.5966/sctm.2013-0104
M3 - Article
C2 - 24292794
AN - SCOPUS:84892762560
SN - 2157-6564
VL - 3
SP - 2
EP - 6
JO - Stem cells translational medicine
JF - Stem cells translational medicine
IS - 1
ER -