Evidence map›Paper›PMID 20844613›Full record

Trial reportTexas Heart Institute journal2010

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.

Jay H Traverse, Timothy D Henry, Douglas E Vaughan, Stephen G Ellis, Carl J Pepine, James T Willerson, David X M Zhao, Lara M Simpson, Marc S Penn, Barry J Byrne and 17 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Texas Heart Institute journal, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00684060 (A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00684060 phase2completednot on this map

A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction

TypeinterventionalSponsorThe University of Texas Health Science Center, HoustonRan2008 to 2012Enrolled87ConditionsLeft Ventricular DysfunctionArmsAdult stem cells, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Stem cell treatment for acute myocardial infarction.The Cochrane database of systematic reviews · 2015
    Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Cardiac tissue engineering and regeneration using cell-based therapy.Stem cells and cloning : advances and applications · 2015
    Review
  19. Article
  20. Regenerative principles enrich cardiac rehabilitation practice.American journal of physical medicine & rehabilitation · 2014
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 1 institution in 1 country.

Jay H TraverseMinneapolis Heart Institute at Abbott Northwestern Hospital, USA.
Timothy D Henry
Douglas E Vaughan
Stephen G Ellis
Carl J Pepine
James T Willerson
David X M Zhao
Lara M Simpson
Marc S Penn
Barry J Byrne
Emerson C Perin
Adrian P Gee
Antonis K Hatzopoulos
David H McKenna
John R Forder
Doris A Taylor
Christopher R Cogle
Sarah Baraniuk
Rachel E Olson
Beth C Jorgenson
Shelly L Sayre
Rachel W Vojvodic
David J Gordon
Sonia I Skarlatos
Lemuel A Moyè
Robert D Simari
Cardiovascular Cell Therapy Research Network
Abbott Northwestern Hospital · US

Funding

Cardiovascular Cell Therapy Research Network - Data Coordinating CenterU01HL087318 · NHLBI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MOYE, LEMUEL A. · 2007 to 2011
$17.6M
UFRCC for Cardiovascular Cell Therapy Research NetworkUM1HL087366 · NHLBI · UNIVERSITY OF FLORIDA · PI PEPINE, CARL J · 2012 to 2018
$4.7M
PROTECTIVE TREATMENT FOR CATHETERSR43HL037164 · NHLBI · DENVER BIOMATERIALS, INC. · PI NEWKIRK, JOHN B · 1987 to 1987
–
NHLBI NIH HHS N01 HB037164NHLBI NIH HHS N01-HB-37164NHLBI NIH HHS U01 HL087318NHLBI NIH HHS U01 HL087318-01NHLBI NIH HHS UM1 HL087366
6 · The paper itself

Abstract

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.

Indexed as

Angioplasty, Balloon, CoronaryBone Marrow TransplantationDouble-Blind MethodEchocardiographyHeart FailureHumansMagnetic Resonance ImagingMyocardial InfarctionMyocardiumPilot ProjectsPlacebo EffectResearch DesignTime FactorsTransplantation, AutologousTreatment OutcomeUnited StatesApoptosisbone marrow cellsbone marrow transplantationcell therapycolony-stimulating factorsfree radicalsheart failureinflammation/prevention & controlinfusions, intra-arterialmagnetic resonance imagingmyocardial infarction/therapymyocardial ischemia/therapymyocardial reperfusion injurymyocytes, cardiacprospective studiesregenerationresearch designstem cellsstem cell transplantationtime factorsventricular function, leftventricular remodeling

Identifiers

PMID20844613
PMCPMC2929864
OpenAlexW1543452484

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.