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

August 12, 2013 updated by: Duke University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients
Time Frame: baseline and 90 days
baseline and 90 days
Occurence of arrhythmia, heart failure and death
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in regional left ventricular function
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Duke Clinical Research Institute

Investigators

  • Principal Investigator: Christopher B Granger, MD, Duke Clinical Research Institute
  • Principal Investigator: Marc E Jolicoeur, MD MSc, Duke Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00003467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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