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
Recruitment status was Not yet recruiting
Sponsor:
Duke University
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00691834
First received: June 3, 2008
Last updated: February 22, 2009
Last verified: February 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction Heart Failure |
Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Improvement in regional left ventricular function [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691834
Contacts
| 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 |
Locations
| United States, North Carolina | |
| Duke Clinical Research Institute | Not yet recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Marc E Jolicoeur, MD MSc 919-668-7808 marc.jolicoeur@duke.edu | |
| Contact: Christopher B Granger, MD 919-668-8900 christopher.granger@duke.edu | |
| Sub-Investigator: Nelson J Chao, MD | |
| Sub-Investigator: Thomas J Povsic, MD PhD | |
| Sub-Investigator: Victor J Dzau, MD | |
Sponsors and Collaborators
Duke University
Investigators
| Principal Investigator: | Christopher B Granger, MD | Duke Clinical Research Institute |
| Principal Investigator: | Marc E Jolicoeur, MD MSc | Duke Clinical Research Institute |
More Information
No publications provided
| Responsible Party: | Dr Christopher B Granger, Duke Clinical Research Institute |
| ClinicalTrials.gov Identifier: | NCT00691834 History of Changes |
| Other Study ID Numbers: | Pro00003467 |
| Study First Received: | June 3, 2008 |
| Last Updated: | February 22, 2009 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Duke University:
|
Magnetic resonance Imaging |
Additional relevant MeSH terms:
|
Heart Failure Infarction Myocardial Infarction Heart Diseases Cardiovascular Diseases |
Ischemia Pathologic Processes Necrosis Myocardial Ischemia Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013