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Withdrawn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
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Magnetic resonance Imaging
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
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
NCT ID
NCT00691834
First Posted
June 3, 2008
Last Updated
August 12, 2013
Sponsor
Duke University
Collaborators
Duke Clinical Research Institute
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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