Safety and Efficacy on Cell-Based Therapy in Patients With Recent Large Acute Myocardial Infarction - Full Text View

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00691834

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 II

MedlinePlus related topics: Heart Attack Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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)
2: Placebo Comparator 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
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:	Christopher B Granger, MD	Duke University
Principal Investigator:	Marc E Jolicoeur, MD MSc	Duke University

More Information

Responsible Party:	Duke Clinical Research Institute ( Dr Christopher B Granger )
Study ID Numbers:	Pro00003467
Study First Received:	June 3, 2008
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00691834
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Duke University:

Magnetic resonance Imaging

Study placed in the following topic categories:

Necrosis
Heart Failure
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009