Status:
COMPLETED
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
Lead Sponsor:
Cytori Therapeutics
Conditions:
Myocardial Infarction
Coronary Arteriosclerosis
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
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 infarct...
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 treatmen...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00442806
Start Date
November 1 2007
End Date
April 1 2012
Last Update
November 26 2013
Active Locations (2)
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1
Erasmus University Medical Centrum, Thorax Center
Rotterdam, Netherlands
2
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007