Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction.
Several previous studies have demonstrated that administration of autologous bone marrow-derived mononuclear cells (BMMNCs) improves cardiac function in patients after acute myocardial infarction (AMI). However, optimum timing of administration has not been investigated in a clinical trial. The Cardiovascular Cell Therapy Research Network was developed and funded by the National Heart, Lung, and Blood Institute to address important questions such as timing of cell delivery and to accelerate research in the use of cell-based therapies. The TIME trial is a randomized, phase II, double-blind, placebo-controlled clinical trial. The 5 member clinical sites of the Cardiovascular Cell Therapy Research Network will enroll 120 eligible patients with moderate-to-large anterior AMIs who have undergone successful percutaneous coronary intervention of the left anterior descending coronary artery and have a left ventricular (LV) ejection fraction </=45% by echocardiography. Participants will have bone marrow aspirations and intracoronary infusions of 150 x 10(6) BMMNCs or placebo on day 3 or day 7 post-AMI. Objectives of this study are (1) to evaluate effects of BMMNCs on regional and global LV function compared to placebo therapy in patients with acute AMI as assessed by cardiac magnetic resonance imaging at 6 months and (2) to assess whether effects of BMMNC infusion on global and regional LV function and safety are influenced by the time of administration. This study will provide further insight into the clinical feasibility and appropriate timing of autologous BMMNC therapy in high-risk patients after AMI and percutaneous coronary intervention.
Traverse
Jay H
JH
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN; University of Minnesota School of Medicine, Minneapolis, MN 55407, USA. trave004@umn.edu
Henry
Timothy D
TD
Vaughan
Douglas E
DE
Vaughn
Douglas E
DE
Ellis
Stephen G
SG
Pepine
Carl J
CJ
Willerson
James T
JT
Zhao
David X M
DX
Piller
Linda B
LB
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
Olson
Rachel E
RE
Jorgenson
Beth C
BC
Sayre
Shelly L
SL
Vojvodic
Rachel W
RW
Gordon
David J
DJ
Skarlatos
Sonia I
SI
Moye'
Lemuel A
LA
Simari
Robert D
RD
D000328:Adult; D015906:Angioplasty, Balloon, Coronary; D016026:Bone Marrow Transplantation; D004311:Double-Blind Method; D005240:Feasibility Studies; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000637:transplantation*; D009203:Myocardial Infarction / Q000628:therapy*; D010865:Pilot Projects; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
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