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

Primary Purpose

Acute Myocardial Infarction, Heart Failure

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intracoronary delivery of unfractionated bone marrow mononuclear cells
Placebo
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Magnetic resonance Imaging

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Intracoronary delivery of unfractionated bone marrow mononuclear cells

    Intracoronary delivery of placebo

    Outcomes

    Primary Outcome Measures

    Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients
    Occurence of arrhythmia, heart failure and death

    Secondary Outcome Measures

    Improvement in regional left ventricular function

    Full Information

    First Posted
    June 3, 2008
    Last Updated
    August 12, 2013
    Sponsor
    Duke University
    Collaborators
    Duke Clinical Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00691834
    Brief Title
    Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction
    Acronym
    ReNeW
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study never received IRB approval. Study was never pursued.
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University
    Collaborators
    Duke Clinical Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction, Heart Failure
    Keywords
    Magnetic resonance Imaging

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Intracoronary delivery of unfractionated bone marrow mononuclear cells
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Intracoronary delivery of placebo
    Intervention Type
    Biological
    Intervention Name(s)
    Intracoronary delivery of unfractionated bone marrow mononuclear cells
    Intervention Description
    Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    Plasma and culture medium (10 ml)
    Primary Outcome Measure Information:
    Title
    Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients
    Time Frame
    baseline and 90 days
    Title
    Occurence of arrhythmia, heart failure and death
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Improvement in regional left ventricular function
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher B Granger, MD
    Organizational Affiliation
    Duke Clinical Research Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marc E Jolicoeur, MD MSc
    Organizational Affiliation
    Duke Clinical Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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