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Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction

NCT ID: NCT00442806

Last Updated: 2013-11-26

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.

Detailed Description

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Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo.

Conditions

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Myocardial Infarction Coronary Arteriosclerosis Cardiovascular Disease Coronary Disease

Keywords

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ADRC Stem Cells Myocardial Infarction STEMI Heart Disease Coronary Artery Disease Coronary Disease ST-Elevation AMI Interventional Cardiology Heart Attack

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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Placebo

Placebo is injected

Group Type PLACEBO_COMPARATOR

Injection of Placebo

Intervention Type OTHER

Placebo is injected

Treatment

ADRC's are injected

Group Type EXPERIMENTAL

Injection of ADRC's

Intervention Type DRUG

ADRC's are injected

Interventions

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Injection of ADRC's

ADRC's are injected

Intervention Type DRUG

Injection of Placebo

Placebo is injected

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Acute myocardial infarction (AMI)
* Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin
* Successful revascularization of the culprit lesion in the major epicardial vessel
* Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI
* Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization.
* Ability to undergo liposuction

Exclusion Criteria

* Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)
* More than 24 hours after acute PCI
* Significant valvular disease
* More than twelve hours between the onset of first symptoms of AMI and revascularization
* Hemodynamic instability within 24 hours prior to randomization
* Neoplasia
* Acute or chronic bacterial or viral infectious disease
* Pacemaker, ICD or any other contra-indication for MRI
* LVEF \<30% or \>50% by Left Ventricular Angiography
* Moderate or severe COPD
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytori Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Duckers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus University Medical Centrum, ThoraxCenter

Locations

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Erasmus University Medical Centrum, Thorax Center

Rotterdam, , Netherlands

Site Status

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status

Countries

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Netherlands Spain

Other Identifiers

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APOLLO - 01

Identifier Type: -

Identifier Source: org_study_id