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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 3, 2008

Last Updated Date

February 22, 2009

Start Date ^†

August 2009

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00691834 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Improvement in regional left ventricular function [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Acute Myocardial Infarction
Heart Failure

Intervention ^†

Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells
Biological: Placebo

Study Arms / Comparison Groups

Experimental: Intracoronary delivery of unfractionated bone marrow mononuclear cells
Placebo Comparator: Intracoronary delivery of placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

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

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00691834

Responsible Party

Dr Christopher B Granger, Duke Clinical Research Institute

Secondary IDs ^††

Study Sponsor ^†

Duke University

Collaborators ^††

Investigators ^†

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

Information Provided By

Duke University

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.