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

Phase 1

Completed

• Conditions: Myocardial Infarction; Cardiovascular Disease; Coronary Arteriosclerosis; Coronary Disease
• Interventions: Other: Injection of Placebo; Drug: Injection of ADRC's

• Registration Number: NCT00442806
• Lead Sponsor: Cytori Therapeutics

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-03-01
• Study First Posted: 2007-03-02
• Study Start: 2007-11
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Key

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Injection of Placebo	Placebo is injected
Treatment	Injection of ADRC's	ADRC's are injected

Primary Outcome Measures

Name	Time	Method
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)	6 months

Secondary Outcome Measures

Name	Time	Method
Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography	6 months

Trial Locations

Locations (2)

Erasmus University Medical Centrum, Thorax Center; 🇳🇱 Rotterdam, Netherlands

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain