Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2009-8-24
pubmed:databankReference
pubmed:abstractText
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.
pubmed:grant
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:status
MEDLINE
pubmed:month
Sep
pubmed:issn
1097-6744
pubmed:author
pubmed-author:ByrneBarry JBJ, pubmed-author:Cardiovascular Cell Therapy Research Network (CCTRN), pubmed-author:CogleChristopher RCR, pubmed-author:EllisStephen GSG, pubmed-author:ForderJohn RJR, pubmed-author:GeeAdrian PAP, pubmed-author:GordonDavid JDJ, pubmed-author:HatzopoulosAntonis KAK, pubmed-author:HenryTimothy DTD, pubmed-author:JorgensonBeth CBC, pubmed-author:McKennaDavid HDH, pubmed-author:Moye'Lemuel ALA, pubmed-author:OlsonRachel ERE, pubmed-author:PennMarc SMS, pubmed-author:PepineCarl JCJ, pubmed-author:PerinEmerson CEC, pubmed-author:PillerLinda BLB, pubmed-author:SayreShelly LSL, pubmed-author:SimariRobert DRD, pubmed-author:SkarlatosSonia ISI, pubmed-author:TaylorDoris ADA, pubmed-author:TraverseJay HJH, pubmed-author:VaughanDouglas EDE, pubmed-author:VaughnDouglas EDE, pubmed-author:VojvodicRachel WRW, pubmed-author:WillersonJames TJT, pubmed-author:ZhaoDavid X MDX
pubmed:issnType
Electronic
pubmed:volume
158
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
356-63
pubmed:dateRevised
2010-11-18
pubmed:meshHeading
pubmed:year
2009
pubmed:articleTitle
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.
pubmed:affiliation
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN; University of Minnesota School of Medicine, Minneapolis, MN 55407, USA. trave004@umn.edu
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study, Clinical Trial, Phase II, Research Support, N.I.H., Extramural