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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00691834
Recruitment Status : Withdrawn (Study never received IRB approval. Study was never pursued.)
First Posted : June 6, 2008
Last Update Posted : August 13, 2013
Duke Clinical Research Institute
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Heart Failure Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Intracoronary delivery of unfractionated bone marrow mononuclear cells
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)

Placebo Comparator: 2
Intracoronary delivery of placebo
Biological: Placebo
Plasma and culture medium (10 ml)

Primary Outcome Measures :
  1. Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients [ Time Frame: baseline and 90 days ]
  2. Occurence of arrhythmia, heart failure and death [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Improvement in regional left ventricular function [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00691834

Sponsors and Collaborators
Duke University
Duke Clinical Research Institute
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Principal Investigator: Christopher B Granger, MD Duke Clinical Research Institute
Principal Investigator: Marc E Jolicoeur, MD MSc Duke Clinical Research Institute

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Responsible Party: Duke University Identifier: NCT00691834     History of Changes
Other Study ID Numbers: Pro00003467
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: November 2012

Keywords provided by Duke University:
Magnetic resonance Imaging

Additional relevant MeSH terms:
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Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases