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Safety and Efficacy on Cell-Based Therapy in Patients With Recent Large Acute Myocardial Infarction (ReNeW)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Duke University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00691834
First received: June 3, 2008
Last updated: February 22, 2009
Last verified: February 2009
History of Changes

June 3, 2008
February 22, 2009
August 2009
December 2010   (final data collection date for primary outcome measure)
  • Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
  • Occurence of arrhythmia, heart failure and death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00691834 on ClinicalTrials.gov Archive Site
Improvement in regional left ventricular function [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy on Cell-Based Therapy in Patients With Recent Large Acute Myocardial Infarction
ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction

The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Myocardial Infarction
  • Heart Failure
  • Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells
    Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)
  • Biological: Placebo
    Plasma and culture medium (10 ml)
  • Experimental: 1
    Intracoronary delivery of unfractionated bone marrow mononuclear cells
    Intervention: Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells
  • Placebo Comparator: 2
    Intracoronary delivery of placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
December 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be at least 18 years of age and no more than 80 years of age.
  • Acute ST-segment elevation MI
  • Symptoms suggestive of acute MI
  • ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
  • Time from symptom onset to enrollment < 120 hours
  • Left ventricular dysfunction by contrast ventriculography or echocardiography
  • EF above 25 % and lower than 40%
  • Focal wall motion akinesis or dyskinesis
  • Clearly identifiable infarct artery
  • Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement

Exclusion Criteria:

  • Planned treatment with bypass surgery or prior CABG
  • Multi-vessel PCI
  • Prior myocardial infarction by history or presence of pathologic Q-waves
  • Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
  • Successful reperfusion < 3 hrs from symptom onset
  • Prior MI or significant chronic heart failure
  • Pacemaker/defibrillator
  • Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
  • Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance<25 and/or serum Cr >2.5 mg/dl)
  • Baseline hematocrit < 30
  • Pregnancy, or lactation/parturition within the past 30 days
  • Active or planned treatment with chemotherapy
  • Anticipated difficulty with 90-day follow-up
  • Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
  • Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial
  • Previous enrollment in this trial
  • Participation in an investigational drug or device study within the past 30 days
Both
18 Years to 80 Years
No
Contact: Christopher B Granger, MD 919-668-8900 christopher.granger@duke.edu
Contact: Marc E Jolicoeur, MD MSc 919-668-7808 marc.jolicoeur@duke.edu
United States
 
NCT00691834
Pro00003467
Yes
Dr Christopher B Granger, Duke Clinical Research Institute
Duke University
Not Provided
Principal Investigator: Christopher B Granger, MD Duke Clinical Research Institute
Principal Investigator: Marc E Jolicoeur, MD MSc Duke Clinical Research Institute
Duke University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP