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

NCT ID: NCT00691834

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-08-31

Brief Summary

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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

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Conditions

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Acute Myocardial Infarction Heart Failure

Keywords

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Magnetic resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Intracoronary delivery of unfractionated bone marrow mononuclear cells

Group Type EXPERIMENTAL

Intracoronary delivery of unfractionated bone marrow mononuclear cells

Intervention Type BIOLOGICAL

Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)

2

Intracoronary delivery of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Plasma and culture medium (10 ml)

Interventions

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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)

Intervention Type BIOLOGICAL

Placebo

Plasma and culture medium (10 ml)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke Clinical Research Institute

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher B Granger, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Marc E Jolicoeur, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Countries

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United States

Other Identifiers

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Pro00003467

Identifier Type: -

Identifier Source: org_study_id