LateTIME: a phase-II, randomized, double-blinded, placebo-controlled, pilot trial evaluating the safety and effect of administration of bone marrow mononuclear cells 2 to 3 weeks after acute myocardial infarction.
A realistic goal for cardiac cell therapy may be to attenuate left ventricular remodeling following acute myocardial infarction to prevent the development of congestive heart failure. Initial clinical trials of cell therapy have delivered cells 1 to 7 days after acute myocardial infarction. However, many patients at risk of developing congestive heart failure may not be ready for cell delivery at that time-point because of clinical instability or hospitalization at facilities without access to cell therapy. Experience with cell delivery 2 to 3 weeks after acute myocardial infarction has not to date been explored in a clinical trial. The objective of the LateTIME study is to evaluate by cardiac magnetic resonance the effect on global and regional left ventricular function, between baseline and 6 months, of a single intracoronary infusion of 150 × 106 autologous bone marrow mononuclear cells (compared with placebo) when that infusion is administered 2 to 3 weeks after moderate-to-large acute myocardial infarction. The 5 clinical sites of the Cardiovascular Cell Therapy Research Network (CCTRN) will enroll a total of 87 eligible patients in a 2:1 bone marrow mononuclear cells-to-placebo patient ratio; these 87 will have undergone successful percutaneous coronary intervention of a major coronary artery and have left ventricular ejection fractions ≤0.45 by echocardiography. When the results become available, this study should provide insight into the clinical feasibility and appropriate timing of autologous cell therapy in high-risk patients after acute myocardial infarction and percutaneous coronary intervention.
Traverse
Jay H
JH
Minneapolis Heart Institute at Abbott Northwestern Hospital, USA.
Henry
Timothy D
TD
Vaughan
Douglas E
DE
Ellis
Stephen G
SG
Pepine
Carl J
CJ
Willerson
James T
JT
Zhao
David X M
DX
Simpson
Lara M
LM
Penn
Marc S
MS
Byrne
Barry J
BJ
Perin
Emerson C
EC
Gee
Adrian P
AP
Hatzopoulos
Antonis K
AK
McKenna
David H
DH
Forder
John R
JR
Taylor
Doris A
DA
Cogle
Christopher R
CR
Baraniuk
Sarah
S
Olson
Rachel E
RE
Jorgenson
Beth C
BC
Sayre
Shelly L
SL
Vojvodic
Rachel W
RW
Gordon
David J
DJ
Skarlatos
Sonia I
SI
Moyè
Lemuel A
LA
Simari
Robert D
RD
D015906:Angioplasty, Balloon, Coronary; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D004311:Double-Blind Method; D004452:Echocardiography; D006333:Heart Failure / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D006801:Humans; D008279:Magnetic Resonance Imaging; D009203:Myocardial Infarction / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D009206:Myocardium / Q000473:pathology; D010865:Pilot Projects; D015990:Placebo Effect; D012107:Research Design; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014481:United States; D016277:Ventricular Function, Left; D020257:Ventricular Remodeling